Clinical trial NCT01076764: Effect of Otamixaban Versus Unfractionated Heparin + Eptifibatide in Patients With Unstable Angina/Non ST Elevation Myocardial Infarction Undergoing Early Invasive Strategy
Official title: Randomized, Double-blind, Triple-dummy Trial to Compare the Efficacy of Otamixaban With Unfractionated Heparin + Eptifibatide, in Patients With Unstable Angina/Non ST Segment Elevation Myocardial Infarction Scheduled to Undergo an Early Invasive Strategy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acute Coronary Syndrome
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2010-02-26
Enrollment: 13220
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Primary Objective:

* To demonstrate the superior efficacy (composite of all-cause death + Myocardial Infarction (MI)) of Otamixaban to Unfractionated Heparin (UFH) + Eptifibatide

Secondary Objectives:

* To demonstrate the superior efficacy (composite of all-cause death + MI + any stroke) of Otamixaban as compared to UFH + Eptifibatide
* To document the effect of Otamixaban on rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction as compared to UFH + eptifibatide
* To document the effect on mortality (all cause death) of Otamixaban as compared to UFH + eptifibatide
* To document the safety of Otamixaban as compared to UFH + eptifibatide
* To document the effect of Otamixaban on thrombotic procedural complications during the index Percutaneous Coronary Intervention (PCI) as compared to UFH + eptifibatide

Detailed description: Up to the interim analysis, patients are randomized to one of the Otamixaban arms or the control arm (UFH + Eptifibatide). Then after interim analysis, patients will be randomized to the continued Otamixaban arm (per Data Monitoring Committee (DMC) decision based on interim analysis results) or the control arm (UFH + Eptifibatide). Except the DMC, all participants will remain blinded to this decision until the end of study.

The total duration of the study period per subject will range between 30 days and 180 days. Study end date being the Day 30 visit of the last randomized patient, follow up will be until Day 180 or study end date whichever comes first.

Eligibility criteria: Inclusion criteria:

Patient with non-ST-segment elevation Acute Coronary Syndrome (NSTE-ACS) with:

1. Ischemic symptoms (chest pain or equivalent) at rest ≥ 10 minutes within 24 hours of randomization,

   AND
2. One of the two following criteria:

   * New ST-segment depression ≥ 0.1 mV (≥1 mm), or transient (\< 30 minutes) ST-segment elevation ≥ 0.1 mV (≥ 1 mm) in at least 2 contiguous leads on the electrocardiogram,
   * Elevation of cardiac biomarkers within 24 hours of randomization, defined as elevated troponin T, troponin I, or CK-MB level above upper limit of normal,

   AND
3. Planned to have a coronary angiography (followed, when indicated, by PCI) as early as possible (after at least 2 hours of treatment with study drug) and within 36 hours (at the latest on Day 3, if justified),

   AND
4. Informed consent obtained in writing.

Exclusion criteria:

* Revascularization procedure already performed for the qualifying event Acute ST-segment elevation MI.
* Patient having received curative dose of anticoagulant treatment (including UFH, LMWH, or bivalirudin) for more than 24 hours prior to randomization or who have been treated by abciximab.
* Inability to discontinue current anticoagulation in order to transition to Investigational Products according to the specified transition timing.
* Patient who can not be treated by aspirin and clopidogrel (or any other oral antiplatelet agent) according to their local labeling.
* Patient who cannot be treated with eptifibatide according to the national labeling (when available). In countries where eptifibatide is not approved the reference label to be considered is either the European labeling or the US labeling
* Patient who cannot be treated with unfractionated heparin according to the national labeling.
* Allergy to otamixaban.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Primary outcomes:
measure: Efficacy: Adjudicated double composite of all-cause of death and new myocardial infarction
timeFrame: from randomization (day 1) to day 7
measure: Safety: Adjudicated Thrombolysis In Myocardial Infarction (TIMI) significant bleeding (composite of TIMI major and minor)
timeFrame: from day 1 to day 7
Secondary outcomes:
measure: Adjudicated Triple efficacy composite of all-cause death, new myocardial infarction and any stroke
timeFrame: from day 1 to day 7
measure: Rehospitalization or prolongation of hospitalization due to a new episode of myocardial ischemia/myocardial infarction
timeFrame: from day 1 to day 30
measure: Adjudicated all-cause death
timeFrame: from day 1 to day 30
measure: Adjudicated Procedural thrombotic complications during the index PCI
timeFrame: during index PCI
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Investigational Site Number 840015
state: Alabama
city: Phoenix
country: United States
facility: Investigational Site Number 840569
state: Arizona
city: Phoenix
country: United States
facility: Investigational Site Number 840703
state: Arizona
city: Anaheim
country: United States
facility: Investigational Site Number 840101
state: California
city: Anaheim
country: United States
facility: Investigational Site Number 840151
state: California
city: Beverley Hills
country: United States
facility: Investigational Site Number 840213
state: California
city: Huntington Beach
country: United States
facility: Investigational Site Number 840572
state: California
city: Long Beach
country: United States
facility: Investigational Site Number 840201
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840071
state: California
city: Los Angeles
country: United States
facility: Investigational Site Number 840557
state: California
city: Northridge
country: United States
facility: Investigational Site Number 840903
state: California
city: San Francisco
country: United States
facility: Investigational Site Number 840065
state: California
city: Santa Rosa
country: United States
facility: Investigational Site Number 840561
state: California
city: Littleton
country: United States
facility: Investigational Site Number 840721
state: Colorado
city: Bridgeport
country: United States
facility: Investigational Site Number 840551
state: Connecticut
city: New Haven
country: United States
facility: Investigational Site Number 840166
state: Connecticut
city: Washington
country: United States
facility: Investigational Site Number 840520
state: District of Columbia
city: Fort Lauderdale
country: United States
facility: Investigational Site Number 840185
state: Florida
city: Jacksonville
country: United States
facility: Investigational Site Number 840028
state: Florida
city: Lake Mary
country: United States
facility: Investigational Site Number 840047
state: Florida
city: Melbourne
country: United States
facility: Investigational Site Number 840500
state: Florida
city: Miami
country: United States
facility: Investigational Site Number 840706
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840009
state: Florida
city: Ocala
country: United States
facility: Investigational Site Number 840146
state: Florida
city: Orlando
country: United States
facility: Investigational Site Number 840577
state: Florida
city: Sarasota
country: United States
facility: Investigational Site Number 840021
state: Florida
city: St. Petersburg
country: United States
facility: Investigational Site Number 840902
state: Florida
city: Tampa
country: United States
facility: Investigational Site Number 840508
state: Florida
city: Gainesville
country: United States
facility: Investigational Site Number 840719
state: Georgia
city: Boise
country: United States
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state: Idaho
city: Aurora
country: United States
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state: Illinois
city: Chicago
country: United States
facility: Investigational Site Number 840190
state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Harvey
country: United States
facility: Investigational Site Number 840521
state: Illinois
city: Joliet
country: United States
facility: Investigational Site Number 840148
state: Illinois
city: Hammond
country: United States
facility: Investigational Site Number 840042
state: Indiana
city: Indianapolis
country: United States
facility: Investigational Site Number 840554
state: Indiana
city: Muncie
country: United States
facility: Investigational Site Number 840560
state: Indiana
city: Ames
country: United States
facility: Investigational Site Number 840904
state: Iowa
city: West Des Moines
country: United States
facility: Investigational Site Number 840058
state: Iowa
city: Overland
country: United States
facility: Investigational Site Number 840912
state: Kansas
city: Louisville
country: United States
facility: Investigational Site Number 840568
state: Kentucky
city: Alexandria
country: United States
facility: Investigational Site Number 840534
state: Louisiana
city: Lake Charles
country: United States
facility: Investigational Site Number 840564
state: Louisiana
city: New Orleans
country: United States
facility: Investigational Site Number 840533
state: Louisiana
city: Dearborn
country: United States
facility: Investigational Site Number 840517
state: Michigan
city: Kalamazoo
country: United States
facility: Investigational Site Number 840544
state: Michigan
city: Saginaw
country: United States
facility: Investigational Site Number 840531
state: Michigan
city: Minneapolis
country: United States
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state: Minnesota
city: Minneapolis
country: United States
facility: Investigational Site Number 840510
state: Minnesota
city: Tupelo
country: United States
facility: Investigational Site Number 840527
state: Mississippi
city: Bridgeton
country: United States
facility: Investigational Site Number 840208
state: Missouri
city: Independence
country: United States
facility: Investigational Site Number 840209
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site Number 840194
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site Number 840138
state: Missouri
city: Kansas City
country: United States
facility: Investigational Site Number 840056
state: Missouri
city: St Louis
country: United States
facility: Investigational Site Number 840530
state: Missouri
city: St Louis
country: United States
facility: Investigational Site Number 840580
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840210
state: Missouri
city: St. Louis
country: United States
facility: Investigational Site Number 840052
state: Missouri
city: Kalispell
country: United States
facility: Investigational Site Number 840529
state: Montana
city: Omaha
country: United States
facility: Investigational Site Number 840059
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840727
state: Nebraska
city: Omaha
country: United States
facility: Investigational Site Number 840079
state: Nebraska
city: Reno
country: United States
facility: Investigational Site Number 840157
state: Nevada
city: Brooklyn
country: United States
facility: Investigational Site Number 840518
state: New York
city: New York
country: United States
facility: Investigational Site Number 840539
state: New York
city: Charlotte
country: United States
facility: Investigational Site Number 840585
state: North Carolina
city: Greenville
country: United States
facility: Investigational Site Number 840515
state: North Carolina
city: Raleigh
country: United States
facility: Investigational Site Number 840566
state: North Carolina
city: Winston Salem
country: United States
facility: Investigational Site Number 840908
state: North Carolina
city: Minot
country: United States
facility: Investigational Site Number 840136
state: North Dakota
city: Toledo
country: United States
facility: Investigational Site Number 840082
state: Ohio
city: Midwest City
country: United States
facility: Investigational Site Number 840025
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840049
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840905
state: Oklahoma
city: Oklahoma City
country: United States
facility: Investigational Site Number 840193
state: Oklahoma
city: Tulsa
country: United States
facility: Investigational Site Number 840901
state: Oklahoma
city: Eugene
country: United States
facility: Investigational Site Number 840206
state: Oregon
city: Chambersburg
country: United States
facility: Investigational Site Number 840540
state: Pennsylvania
city: Doylestown
country: United States
facility: Investigational Site Number 840519
state: Pennsylvania
city: Erie
country: United States
facility: Investigational Site Number 840003
state: Pennsylvania
city: Harrisburg
country: United States
facility: Investigational Site Number 840098
state: Pennsylvania
city: Philadelphia
country: United States
facility: Investigational Site Number 840573
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840075
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Investigational Site Number 840911
state: Pennsylvania
city: Washington
country: United States
facility: Investigational Site Number 840211
state: Pennsylvania
city: Oak Ridge
country: United States
facility: Investigational Site Number 840072
state: Tennessee
city: Amarillo
country: United States
facility: Investigational Site Number 840023
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840203
state: Texas
city: Austin
country: United States
facility: Investigational Site Number 840574
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840060
state: Texas
city: Dallas
country: United States
facility: Investigational Site Number 840578
state: Texas
city: Fort Worth
country: United States
facility: Investigational Site Number 840715
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840090
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840207
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840559
state: Texas
city: Houston
country: United States
facility: Investigational Site Number 840586
state: Texas
city: Tyler
country: United States
facility: Investigational Site Number 840087
state: Texas
city: Victoria
country: United States
facility: Investigational Site Number 840910
state: Texas
city: Wichita Falls
country: United States
facility: Investigational Site Number 840555
state: Texas
city: Richmond
country: United States
facility: Investigational Site Number 840553
state: Virginia
city: Richmond
country: United States
facility: Investigational Site Number 840188
state: Virginia
city: Salem
country: United States
facility: Investigational Site Number 840165
state: Virginia
city: Winchester
country: United States
facility: Investigational Site Number 840565
state: Virginia
city: Tacoma
country: United States
facility: Investigational Site Number 840121
state: Washington
city: Manitowoc
country: United States
facility: Investigational Site Number 840513
state: Wisconsin
city: Adrogue
country: Argentina
facility: Investigational Site Number 032048
city: Avellaneda
country: Argentina
facility: Investigational Site Number 032013
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032046
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032043
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032003
city: Buenos Aires
country: Argentina
facility: Investigational Site Number 032032
city: Caba
country: Argentina
facility: Investigational Site Number 032014
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032007
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032039
city: Capital Federal
country: Argentina
facility: Investigational Site Number 032045
city: Ciudad Autonoma De Bs.As
country: Argentina
facility: Investigational Site Number 032029
city: Ciudad De Buenos Aires
country: Argentina
facility: Investigational Site Number 032036
city: Cordoba
country: Argentina
facility: Investigational Site Number 032044
city: Cordoba
country: Argentina
facility: Investigational Site Number 032010
city: Corrientes
country: Argentina
facility: Investigational Site Number 032001
city: Florencio Varela
country: Argentina
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city: La Plata
country: Argentina
facility: Investigational Site Number 032018
city: La Plata
country: Argentina
facility: Investigational Site Number 032027
city: Mendoza
country: Argentina
facility: Investigational Site Number 032020
city: Olivos
country: Argentina
facility: Investigational Site Number 032033
city: Pilar
country: Argentina
facility: Investigational Site Number 032022
city: Resistencia
country: Argentina
facility: Investigational Site Number 032023
city: Resistencia
country: Argentina
facility: Investigational Site Number 032002
city: Rosario
country: Argentina
facility: Investigational Site Number 032004
city: Rosario
country: Argentina
facility: Investigational Site Number 032005
city: Rosario
country: Argentina
facility: Investigational Site Number 032021
city: Rosario
country: Argentina
facility: Investigational Site Number 032028
city: Rosario
country: Argentina
facility: Investigational Site Number 032040
city: San Luis
country: Argentina
facility: Investigational Site Number 032025
city: San Martin
country: Argentina
facility: Investigational Site Number 032024
city: San Miguel De Tucuman
country: Argentina
facility: Investigational Site Number 032008
city: Santa Fe
country: Argentina
facility: Investigational Site Number 032041
city: Santa Fe
country: Argentina
facility: Investigational Site Number 032006
city: Adelaide
country: Australia
facility: Investigational Site Number 036008
city: Ballarat
country: Australia
facility: Investigational Site Number 036004
city: Concord
country: Australia
facility: Investigational Site Number 036010
city: Herston
country: Australia
facility: Investigational Site Number 036001
city: Hobart
country: Australia
facility: Investigational Site Number 036913
city: Liverpool
country: Australia
facility: Investigational Site Number 036011
city: Prahran
country: Australia
facility: Investigational Site Number 036003
city: Wien
country: Austria
facility: Investigational Site Number 040002
city: Wien
country: Austria
facility: Investigational Site Number 040001
city: Gomel
country: Belarus
facility: Investigational Site Number 112004
city: Minsk
country: Belarus
facility: Investigational Site Number 112003
city: Minsk
country: Belarus
facility: Investigational Site Number 112002
city: Minsk
country: Belarus
facility: Investigational Site Number 112001
city: Bonheiden
country: Belgium
facility: Investigational Site Number 056001
city: Brugge
country: Belgium
facility: Investigational Site Number 056007
city: Brussels
country: Belgium
facility: Investigational Site Number 056003
city: Haine-Saint-Paul
country: Belgium
facility: Investigational Site Number 056006
city: Leuven
country: Belgium
facility: Investigational Site Number 056008
city: Campinas
country: Brazil
facility: Investigational Site Number 076025
city: Fortaleza
country: Brazil
facility: Investigational Site Number 076011
city: Marilia
country: Brazil
facility: Investigational Site Number 076015
city: Maringa
country: Brazil
facility: Investigational Site Number 076016
city: Passo Fundo
country: Brazil
facility: Investigational Site Number 076013
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076009
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076001
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076022
city: Porto Alegre
country: Brazil
facility: Investigational Site Number 076004
city: Recife
country: Brazil
facility: Investigational Site Number 076023
city: Recife
country: Brazil
facility: Investigational Site Number 076030
city: Rio De Janeiro
country: Brazil
facility: Investigational Site Number 076027
city: Salvador
country: Brazil
facility: Investigational Site Number 076029
city: Sao Jose Do Rio Preto
country: Brazil
facility: Investigational Site Number 076014
city: Sao Jose Do Rio Preto
country: Brazil
facility: Investigational Site Number 076002
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076012
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076020
city: Sao Paulo
country: Brazil
facility: Investigational Site Number 076007
city: Uberlandia
country: Brazil
facility: Investigational Site Number 076008
city: Votuporanga
country: Brazil
facility: Investigational Site Number 076024
city: Blagoevgrad
country: Bulgaria
facility: Investigational Site Number 100511
city: Kazanlak
country: Bulgaria
facility: Investigational Site Number 100508
city: Pazardjik
country: Bulgaria
facility: Investigational Site Number 100512
city: Pleven
country: Bulgaria
facility: Investigational Site Number 100505
city: Ruse
country: Bulgaria
facility: Investigational Site Number 100509
city: Sandanski
country: Bulgaria
facility: Investigational Site Number 100510
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100501
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100502
city: Sofia
country: Bulgaria
facility: Investigational Site Number 100503
city: Varna
country: Bulgaria
facility: Investigational Site Number 100507
city: Veliko Tarnovo
country: Bulgaria
facility: Investigational Site Number 100504
city: Yambol
country: Bulgaria
facility: Investigational Site Number 100506
city: Gatineau
country: Canada
facility: Investigational Site Number 124005
city: Hamilton
country: Canada
facility: Investigational Site Number 124006
city: Montreal
country: Canada
facility: Investigational Site Number 124004
city: Quebec
country: Canada
facility: Investigational Site Number 124001
city: Sherbrooke
country: Canada
facility: Investigational Site Number 124007
city: St. John
country: Canada
facility: Investigational Site Number 124009
city: Toronto
country: Canada
facility: Investigational Site Number 124002
city: Antofagasta
country: Chile
facility: Investigational Site Number 152003
city: Concepcion
country: Chile
facility: Investigational Site Number 152906
city: Iquique
country: Chile
facility: Investigational Site Number 152005
city: Santiago
country: Chile
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city: Santiago
country: Chile
facility: Investigational Site Number 152001
city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
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city: Santiago
country: Chile
facility: Investigational Site Number 152010
city: Santiago
country: Chile
facility: Investigational Site Number 152012
city: Talcahuano
country: Chile
facility: Investigational Site Number 152011
city: Temuco
country: Chile
facility: Investigational Site Number 152908
city: Temuco
country: Chile
facility: Investigational Site Number 152913
city: Valdivia
country: Chile
facility: Investigational Site Number 152016
city: Valparaíso
country: Chile
facility: Investigational Site Number 152912
city: Vina Del Mar
country: Chile
facility: Investigational Site Number 152907
city: Viña Del Mar
country: Chile
facility: Investigational Site Number 152910
city: Barranquilla
country: Colombia
facility: Investigational Site Number 170016
city: Bogota
country: Colombia
facility: Investigational Site Number 170009
city: Bogotá
country: Colombia
facility: Investigational Site Number 170011
city: Bucaramanga
country: Colombia
facility: Investigational Site Number 170002
city: Cali
country: Colombia
facility: Investigational Site Number 170012
city: Medellin
country: Colombia
facility: Investigational Site Number 170001
city: Medellin
country: Colombia
facility: Investigational Site Number 170003
city: Medellin
country: Colombia
facility: Investigational Site Number 170017
city: Slavonski Brod
country: Croatia
facility: Investigational Site Number 191502
city: Zagreb
country: Croatia
facility: Investigational Site Number 191503
city: Zagreb
country: Croatia
facility: Investigational Site Number 191505
city: Zagreb
country: Croatia
facility: Investigational Site Number 191506
city: Brno
country: Czech Republic
facility: Investigational Site Number 203005
city: Hradec Kralove
country: Czech Republic
facility: Investigational Site Number 203903
city: Liberec
country: Czech Republic
facility: Investigational Site Number 203902
city: Olomouc
country: Czech Republic
facility: Investigational Site Number 203009
city: Ostrava - Poruba
country: Czech Republic
facility: Investigational Site Number 203010
city: Praha 10
country: Czech Republic
facility: Investigational Site Number 203001
city: Praha 2
country: Czech Republic
facility: Investigational Site Number 203901
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203007
city: Praha 5
country: Czech Republic
facility: Investigational Site Number 203003
city: Usti Nad Labem
country: Czech Republic
facility: Investigational Site Number 203002
city: Zlin
country: Czech Republic
facility: Investigational Site Number 203006
city: Cairo
country: Egypt
facility: Investigational Site Number 818504
city: Cairo
country: Egypt
facility: Investigational Site Number 818501
city: Cairo
country: Egypt
facility: Investigational Site Number 818502
city: Giza
country: Egypt
facility: Investigational Site Number 818503
city: Tallinn
country: Estonia
facility: Investigational Site Number 233001
city: Tallinn
country: Estonia
facility: Investigational Site Number 233901
city: Avignon Cedex 2
country: France
facility: Investigational Site Number 250016
city: Bayonne
country: France
facility: Investigational Site Number 250010
city: Belfort Cedex
country: France
facility: Investigational Site Number 250002
city: Besancon
country: France
facility: Investigational Site Number 250001
city: Creteil
country: France
facility: Investigational Site Number 250006
city: Dijon Cedex
country: France
facility: Investigational Site Number 250003
city: Le Chesnay Cedex
country: France
facility: Investigational Site Number 250013
city: Montfermeil
country: France
facility: Investigational Site Number 250012
city: Mulhouse
country: France
facility: Investigational Site Number 250005
city: Mulhouse
country: France
facility: Investigational Site Number 250015
city: Paris
country: France
facility: Investigational Site Number 250009
city: Pau
country: France
facility: Investigational Site Number 250011
city: Rouen
country: France
facility: Investigational Site Number 250007
city: Strasbourg
country: France
facility: Investigational Site Number 250014
city: Toulouse Cedex 9
country: France
facility: Investigational Site Number 250008
city: Berlin
country: Germany
facility: Investigational Site Number 276022
city: Berlin
country: Germany
facility: Investigational Site Number 276004
city: Berlin
country: Germany
facility: Investigational Site Number 276024
city: Bonn
country: Germany
facility: Investigational Site Number 276023
city: Frankfurt Am Main
country: Germany
facility: Investigational Site Number 276006
city: Freiburg
country: Germany
facility: Investigational Site Number 276901
city: Hamburg
country: Germany
facility: Investigational Site Number 276003
city: Hamburg
country: Germany
facility: Investigational Site Number 276902
city: Heidelberg
country: Germany
facility: Investigational Site Number 276009
city: Heidenheim
country: Germany
facility: Investigational Site Number 276904
city: Kassel
country: Germany
facility: Investigational Site Number 276002
city: Langen
country: Germany
facility: Investigational Site Number 276013
city: Mainz
country: Germany
facility: Investigational Site Number 276001
city: Mönchengladbach
country: Germany
facility: Investigational Site Number 276905
city: München
country: Germany
facility: Investigational Site Number 276005
city: Rostock
country: Germany
facility: Investigational Site Number 276018
city: Alexandroupolis
country: Greece
facility: Investigational Site Number 300009
city: Athens
country: Greece
facility: Investigational Site Number 300004
city: Athens
country: Greece
facility: Investigational Site Number 300001
city: Athens
country: Greece
facility: Investigational Site Number 300011
city: Chios
country: Greece
facility: Investigational Site Number 300007
city: Larissa
country: Greece
facility: Investigational Site Number 300008
city: Melissia
country: Greece
facility: Investigational Site Number 300003
city: N. Ionia
country: Greece
facility: Investigational Site Number 300005
city: Patras
country: Greece
facility: Investigational Site Number 300002
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300010
city: Thessaloniki
country: Greece
facility: Investigational Site Number 300006
city: Chai Wan
country: Hong Kong
facility: Investigational Site Number 344001
city: Budapest
country: Hungary
facility: Investigational Site Number 348003
city: Budapest
country: Hungary
facility: Investigational Site Number 348008
city: Budapest
country: Hungary
facility: Investigational Site Number 348002
city: Budapest
country: Hungary
facility: Investigational Site Number 348004
city: Szeged
country: Hungary
facility: Investigational Site Number 348009
city: Szekesfehervar
country: Hungary
facility: Investigational Site Number 348007
city: Szolnok
country: Hungary
facility: Investigational Site Number 348001
city: Szombathely
country: Hungary
facility: Investigational Site Number 348005
city: Zalaegerszeg
country: Hungary
facility: Investigational Site Number 348006
city: Ahmedabad
country: India
facility: Investigational Site Number 356019
city: Ahmedabad
country: India
facility: Investigational Site Number 356004
city: Ahmedabad
country: India
facility: Investigational Site Number 356007
city: Allahabad
country: India
facility: Investigational Site Number 356012
city: Bangalore
country: India
facility: Investigational Site Number 356008
city: Chandigarh
country: India
facility: Investigational Site Number 356020
city: Gurgaon
country: India
facility: Investigational Site Number 356029
city: Gurgaon
country: India
facility: Investigational Site Number 356027
city: Hyderabad
country: India
facility: Investigational Site Number 356040
city: Hyderabad
country: India
facility: Investigational Site Number 356046
city: Jaipur
country: India
facility: Investigational Site Number 356014
city: Karamsad
country: India
facility: Investigational Site Number 356003
city: Kochi
country: India
facility: Investigational Site Number 356037
city: Kolkata
country: India
facility: Investigational Site Number 356034
city: Madurai
country: India
facility: Investigational Site Number 356039
city: Mangalore
country: India
facility: Investigational Site Number 356018
city: Mumbai
country: India
facility: Investigational Site Number 356021
city: Mumbai
country: India
facility: Investigational Site Number 356016
city: Mumbai
country: India
facility: Investigational Site Number 356031
city: Mumbai
country: India
facility: Investigational Site Number 356032
city: Mysore
country: India
facility: Investigational Site Number 356011
city: Nagpur
country: India
facility: Investigational Site Number 356022
city: Nagpur
country: India
facility: Investigational Site Number 356035
city: Nagpur
country: India
facility: Investigational Site Number 356023
city: Nashik
country: India
facility: Investigational Site Number 356036
city: New Delhi
country: India
facility: Investigational Site Number 356025
city: New Delhi
country: India
facility: Investigational Site Number 356001
city: New Delhi
country: India
facility: Investigational Site Number 356026
city: Pune
country: India
facility: Investigational Site Number 356010
city: Pune
country: India
facility: Investigational Site Number 356033
city: Secunderabad
country: India
facility: Investigational Site Number 356024
city: Varanasi
country: India
facility: Investigational Site Number 356002
city: Vijaywada
country: India
facility: Investigational Site Number 356044
city: Bandung
country: Indonesia
facility: Investigational Site Number 360505
city: Depok
country: Indonesia
facility: Investigational Site Number 360501
city: Jakarta
country: Indonesia
facility: Investigational Site Number 360506
city: Jakarta
country: Indonesia
facility: Investigational Site Number 360503
city: Jakarta
country: Indonesia
facility: Investigational Site Number 360502
city: Afula
country: Israel
facility: Investigational Site Number 376005
city: Ashkelon
country: Israel
facility: Investigational Site Number 376003
city: Hadera
country: Israel
facility: Investigational Site Number 376011
city: Haifa
country: Israel
facility: Investigational Site Number 376004
city: Haifa
country: Israel
facility: Investigational Site Number 376009
city: Holon
country: Israel
facility: Investigational Site Number 376010
city: Jerusalem
country: Israel
facility: Investigational Site Number 376002
city: Jerusalem
country: Israel
facility: Investigational Site Number 376013
city: Safed
country: Israel
facility: Investigational Site Number 376007
city: Tel Aviv
country: Israel
facility: Investigational Site Number 376008
city: Tel Hashomer
country: Israel
facility: Investigational Site Number 376001
city: Tzrifin
country: Israel
facility: Investigational Site Number 376012
city: Bergamo
country: Italy
facility: Investigational Site Number 380902
city: Bologna
country: Italy
facility: Investigational Site Number 380918
city: Brescia
country: Italy
facility: Investigational Site Number 380904
city: Brescia
country: Italy
facility: Investigational Site Number 380928
city: Castellanza
country: Italy
facility: Investigational Site Number 380929
city: Catania
country: Italy
facility: Investigational Site Number 380930
city: Catania
country: Italy
facility: Investigational Site Number 380912
city: Cittadella
country: Italy
facility: Investigational Site Number 380932
city: Conegliano
country: Italy
facility: Investigational Site Number 380926
city: Empoli
country: Italy
facility: Investigational Site Number 380909
city: Forlì
country: Italy
facility: Investigational Site Number 380924
city: Livorno
country: Italy
facility: Investigational Site Number 380908
city: Massa
country: Italy
facility: Investigational Site Number 380923
city: Massa
country: Italy
facility: Investigational Site Number 380935
city: Messina
country: Italy
facility: Investigational Site Number 380933
city: Milano
country: Italy
facility: Investigational Site Number 380910
city: Modena
country: Italy
facility: Investigational Site Number 380905
city: Napoli
country: Italy
facility: Investigational Site Number 380936
city: Perugia
country: Italy
facility: Investigational Site Number 380901
city: Pescara
country: Italy
facility: Investigational Site Number 380907
city: Pordenone
country: Italy
facility: Investigational Site Number 380919
city: Reggio Emilia
country: Italy
facility: Investigational Site Number 380916
city: Roma
country: Italy
facility: Investigational Site Number 380931
city: Roma
country: Italy
facility: Investigational Site Number 380917
city: Rovigo
country: Italy
facility: Investigational Site Number 380927
city: Rozzano
country: Italy
facility: Investigational Site Number 380921
city: Seriate
country: Italy
facility: Investigational Site Number 380914
city: Treviso
country: Italy
facility: Investigational Site Number 380925
city: Amman
country: Jordan
facility: Investigational Site Number 400501
city: Irbid
country: Jordan
facility: Investigational Site Number 400502
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 410005
city: Busan
country: Korea, Republic of
facility: Investigational Site Number 410006
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410002
city: Daegu
country: Korea, Republic of
facility: Investigational Site Number 410014
city: Daejeon
country: Korea, Republic of
facility: Investigational Site Number 410017
city: Goyang
country: Korea, Republic of
facility: Investigational Site Number 410004
city: Guri
country: Korea, Republic of
facility: Investigational Site Number 410018
city: Gwangju
country: Korea, Republic of
facility: Investigational Site Number 410016
city: Seongnam
country: Korea, Republic of
facility: Investigational Site Number 410007
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410008
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410012
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410011
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410001
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410009
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410010
city: Seoul
country: Korea, Republic of
facility: Investigational Site Number 410003
city: Suwon
country: Korea, Republic of
facility: Investigational Site Number 410013
city: Wonju
country: Korea, Republic of
facility: Investigational Site Number 410015
city: Daugavpils
country: Latvia
facility: Investigational Site Number 428004
city: Liepaja
country: Latvia
facility: Investigational Site Number 428002
city: Riga
country: Latvia
facility: Investigational Site Number 428001
city: Riga
country: Latvia
facility: Investigational Site Number 428003
city: Beirut
country: Lebanon
facility: Investigational Site Number 422502
city: Beirut
country: Lebanon
facility: Investigational Site Number 422505
city: Kaunas
country: Lithuania
facility: Investigational Site Number 440003
city: Siauliai
country: Lithuania
facility: Investigational Site Number 440001
city: Vilnius
country: Lithuania
facility: Investigational Site Number 440904
city: Skopje
country: Macedonia, The Former Yugoslav Republic of
facility: Investigational Site Number 807501
city: Kuching
country: Malaysia
facility: Investigational Site Number 458001
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484009
city: Aguascalientes
country: Mexico
facility: Investigational Site Number 484907
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484902
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484015
city: Guadalajara
country: Mexico
facility: Investigational Site Number 484901
city: Merida
country: Mexico
facility: Investigational Site Number 484019
city: Mexico City
country: Mexico
facility: Investigational Site Number 484003
city: Monterrey
country: Mexico
facility: Investigational Site Number 484004
city: Morelia, Michoacan
country: Mexico
facility: Investigational Site Number 484910
city: México Df
country: Mexico
facility: Investigational Site Number 484914
city: Puebla
country: Mexico
facility: Investigational Site Number 484020
city: Queretaro
country: Mexico
facility: Investigational Site Number 484017
city: San Luis Potosi
country: Mexico
facility: Investigational Site Number 484012
city: San Luis Potosi
country: Mexico
facility: Investigational Site Number 484911
city: Xalapa
country: Mexico
facility: Investigational Site Number 484013
city: Podgorica
country: Montenegro
facility: Investigational Site Number 499501
city: Alkmaar
country: Netherlands
facility: Investigational Site Number 528003
city: Arnhem
country: Netherlands
facility: Investigational Site Number 528005
city: Leeuwarden
country: Netherlands
facility: Investigational Site Number 528007
city: Nieuwegein
country: Netherlands
facility: Investigational Site Number 528004
city: Rotterdam
country: Netherlands
facility: Investigational Site Number 528002
city: Auckland
country: New Zealand
facility: Investigational Site Number 554004
city: Hamilton
country: New Zealand
facility: Investigational Site Number 554001
city: Nelson
country: New Zealand
facility: Investigational Site Number 554002
city: Arendal
country: Norway
facility: Investigational Site Number 578903
city: Bergen
country: Norway
facility: Investigational Site Number 578901
city: Stavanger
country: Norway
facility: Investigational Site Number 578902
city: Panama
country: Panama
facility: Investigational Site Number 591504
city: Panamá
country: Panama
facility: Investigational Site Number 591502
city: Lambayeque
country: Peru
facility: Investigational Site Number 604005
city: Lima
country: Peru
facility: Investigational Site Number 604002
city: Lima
country: Peru
facility: Investigational Site Number 604011
city: Lima
country: Peru
facility: Investigational Site Number 604014
city: Lima
country: Peru
facility: Investigational Site Number 604003
city: Lima
country: Peru
facility: Investigational Site Number 604017
city: Lima
country: Peru
facility: Investigational Site Number 604006
city: Lima
country: Peru
facility: Investigational Site Number 604012
city: Lima
country: Peru
facility: Investigational Site Number 604008
city: Bialystok
country: Poland
facility: Investigational Site Number 616005
city: Bialystok
country: Poland
facility: Investigational Site Number 616038
city: Bydgoszcz
country: Poland
facility: Investigational Site Number 616017
city: Bytom
country: Poland
facility: Investigational Site Number 616009
city: Elblag
country: Poland
facility: Investigational Site Number 616040
city: Elk
country: Poland
facility: Investigational Site Number 616027
city: Gdansk
country: Poland
facility: Investigational Site Number 616023
city: Jelenia Gora
country: Poland
facility: Investigational Site Number 616032
city: Katowice
country: Poland
facility: Investigational Site Number 616037
city: Katowice
country: Poland
facility: Investigational Site Number 616046
city: Klodzko
country: Poland
facility: Investigational Site Number 616034
city: Krakow
country: Poland
facility: Investigational Site Number 616045
city: Krakow
country: Poland
facility: Investigational Site Number 616002
city: Lodz
country: Poland
facility: Investigational Site Number 616029
city: Lomza
country: Poland
facility: Investigational Site Number 616004
city: Lubin
country: Poland
facility: Investigational Site Number 616024
city: Lublin
country: Poland
facility: Investigational Site Number 616041
city: Ostroleka
country: Poland
facility: Investigational Site Number 616016
city: Radom
country: Poland
facility: Investigational Site Number 616003
city: Radom
country: Poland
facility: Investigational Site Number 616047
city: Rybnik
country: Poland
facility: Investigational Site Number 616033
city: Tarnów
country: Poland
facility: Investigational Site Number 616019
city: Torun
country: Poland
facility: Investigational Site Number 616022
city: Walbrzych
country: Poland
facility: Investigational Site Number 616018
city: Warszawa
country: Poland
facility: Investigational Site Number 616014
city: Warszawa
country: Poland
facility: Investigational Site Number 616001
city: Wloclawek
country: Poland
facility: Investigational Site Number 616031
city: Wroclaw
country: Poland
facility: Investigational Site Number 616015
city: Zamosc
country: Poland
facility: Investigational Site Number 616020
city: Almada
country: Portugal
facility: Investigational Site Number 620010
city: Amadora
country: Portugal
facility: Investigational Site Number 620006
city: Coimbra
country: Portugal
facility: Investigational Site Number 620001
city: Coimbra
country: Portugal
facility: Investigational Site Number 620002
city: Lisboa
country: Portugal
facility: Investigational Site Number 620003
city: Ponta Delgada
country: Portugal
facility: Investigational Site Number 620015
city: Setúbal
country: Portugal
facility: Investigational Site Number 620004
city: Évora
country: Portugal
facility: Investigational Site Number 620011
city: Brasov
country: Romania
facility: Investigational Site Number 642002
city: Bucuresti
country: Romania
facility: Investigational Site Number 642004
city: Bucuresti
country: Romania
facility: Investigational Site Number 642001
city: Cluj Napoca
country: Romania
facility: Investigational Site Number 642005
city: Targu-Mures
country: Romania
facility: Investigational Site Number 642003
city: Barnaul
country: Russian Federation
facility: Investigational Site Number 643018
city: Ekaterinburg
country: Russian Federation
facility: Investigational Site Number 643015
city: Kemerovo
country: Russian Federation
facility: Investigational Site Number 643011
city: Krasnodar
country: Russian Federation
facility: Investigational Site Number 643014
city: Krasnoyarsk
country: Russian Federation
facility: Investigational Site Number 643021
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643005
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643004
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643020
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643003
city: Moscow
country: Russian Federation
facility: Investigational Site Number 643001
city: Nizniy Novgorod
country: Russian Federation
facility: Investigational Site Number 643016
city: Novosibirsk
country: Russian Federation
facility: Investigational Site Number 643024
city: Saint-Peterburg
country: Russian Federation
facility: Investigational Site Number 643008
city: Saint-Petersburg
country: Russian Federation
facility: Investigational Site Number 643019
city: Samara
country: Russian Federation
facility: Investigational Site Number 643013
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643006
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643025
city: St-Petersburg
country: Russian Federation
facility: Investigational Site Number 643007
city: Tomsk
country: Russian Federation
facility: Investigational Site Number 643012
city: Volgograd
country: Russian Federation
facility: Investigational Site Number 643023
city: Yaroslavl
country: Russian Federation
facility: Investigational Site Number 643017
city: Belgrade
country: Serbia
facility: Investigational Site Number 688505
city: Kragujevac
country: Serbia
facility: Investigational Site Number 688501
city: Nis
country: Serbia
facility: Investigational Site Number 688503
city: Sremska Kamenica
country: Serbia
facility: Investigational Site Number 688502
city: Zemun
country: Serbia
facility: Investigational Site Number 688504
city: Zemun
country: Serbia
facility: Investigational Site Number 688506
city: Singapore
country: Singapore
facility: Investigational Site Number 702001
city: Singapore
country: Singapore
facility: Investigational Site Number 702002
city: Banska Bystrica
country: Slovakia
facility: Investigational Site Number 703003
city: Martin
country: Slovakia
facility: Investigational Site Number 703002
city: Nitra
country: Slovakia
facility: Investigational Site Number 703001
city: Alberton
country: South Africa
facility: Investigational Site Number 710004
city: Cape Town
country: South Africa
facility: Investigational Site Number 710005
city: Cape Town
country: South Africa
facility: Investigational Site Number 710001
city: Centurion
country: South Africa
facility: Investigational Site Number 710003
city: Kuils River
country: South Africa
facility: Investigational Site Number 710002
city: Pretoria
country: South Africa
facility: Investigational Site Number 710007
city: Alcorcón
country: Spain
facility: Investigational Site Number 724013
city: Alicante
country: Spain
facility: Investigational Site Number 724001
city: Badalona
country: Spain
facility: Investigational Site Number 724014
city: Barcelona
country: Spain
facility: Investigational Site Number 724022
city: Barcelona
country: Spain
facility: Investigational Site Number 724021
city: Barcelona
country: Spain
facility: Investigational Site Number 724025
city: Barcelona
country: Spain
facility: Investigational Site Number 724002
city: Barcelona
country: Spain
facility: Investigational Site Number 724901
city: Cáceres
country: Spain
facility: Investigational Site Number 724007
city: Elche
country: Spain
facility: Investigational Site Number 724026
city: Galdakao
country: Spain
facility: Investigational Site Number 724016
city: Girona
country: Spain
facility: Investigational Site Number 724023
city: La Laguna
country: Spain
facility: Investigational Site Number 724006
city: Madrid
country: Spain
facility: Investigational Site Number 724003
city: Madrid
country: Spain
facility: Investigational Site Number 724902
city: Madrid
country: Spain
facility: Investigational Site Number 724027
city: Murcia
country: Spain
facility: Investigational Site Number 724904
city: Málaga
country: Spain
facility: Investigational Site Number 724017
city: San Juan De Alicante
country: Spain
facility: Investigational Site Number 724018
city: Santander
country: Spain
facility: Investigational Site Number 724005
city: Santiago De Compostela
country: Spain
facility: Investigational Site Number 724012
city: Terrassa
country: Spain
facility: Investigational Site Number 724903
city: Torrevieja
country: Spain
facility: Investigational Site Number 724010
city: Valencia
country: Spain
facility: Investigational Site Number 724024
city: Lugano
country: Switzerland
facility: Investigational Site Number 756001
city: Zürich
country: Switzerland
facility: Investigational Site Number 756002
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 158007
city: Kaohsiung
country: Taiwan
facility: Investigational Site Number 158002
city: Linkou
country: Taiwan
facility: Investigational Site Number 158003
city: Taichung
country: Taiwan
facility: Investigational Site Number 158008
city: Taipei
country: Taiwan
facility: Investigational Site Number 158904
city: Taipei
country: Taiwan
facility: Investigational Site Number 158001
city: Taipei
country: Taiwan
facility: Investigational Site Number 158009
city: Bangkok
country: Thailand
facility: Investigational Site Number 764002
city: Bangkok
country: Thailand
facility: Investigational Site Number 764901
city: Bangkok
country: Thailand
facility: Investigational Site Number 764005
city: Khon Kaen
country: Thailand
facility: Investigational Site Number 764004
city: Klong Luang
country: Thailand
facility: Investigational Site Number 764007
city: Muang
country: Thailand
facility: Investigational Site Number 764903
city: Rajathavee
country: Thailand
facility: Investigational Site Number 764006
city: Ariana
country: Tunisia
facility: Investigational Site Number 788002
city: Monastir
country: Tunisia
facility: Investigational Site Number 788005
city: Monastir
country: Tunisia
facility: Investigational Site Number 788006
city: Tunis
country: Tunisia
facility: Investigational Site Number 788001
city: Tunis
country: Tunisia
facility: Investigational Site Number 788004
city: Adana
country: Turkey
facility: Investigational Site Number 792010
city: Ankara
country: Turkey
facility: Investigational Site Number 792023
city: Antalya
country: Turkey
facility: Investigational Site Number 792009
city: Bursa
country: Turkey
facility: Investigational Site Number 792008
city: Bursa
country: Turkey
facility: Investigational Site Number 792022
city: Edirne
country: Turkey
facility: Investigational Site Number 792030
city: Erzurum
country: Turkey
facility: Investigational Site Number 792006
city: Eskisehir
country: Turkey
facility: Investigational Site Number 792020
city: Gaziantep
country: Turkey
facility: Investigational Site Number 792004
city: Istanbul
country: Turkey
facility: Investigational Site Number 792018
city: Istanbul
country: Turkey
facility: Investigational Site Number 792032
city: Istanbul
country: Turkey
facility: Investigational Site Number 792028
city: Istanbul
country: Turkey
facility: Investigational Site Number 792016
city: Istanbul
country: Turkey
facility: Investigational Site Number 792029
city: Izmir
country: Turkey
facility: Investigational Site Number 792011
city: Izmir
country: Turkey
facility: Investigational Site Number 792001
city: Izmir
country: Turkey
facility: Investigational Site Number 792003
city: Kayseri
country: Turkey
facility: Investigational Site Number 792012
city: Kocaeli
country: Turkey
facility: Investigational Site Number 792014
city: Konya
country: Turkey
facility: Investigational Site Number 792015
city: Malatya
country: Turkey
facility: Investigational Site Number 792025
city: Mersin
country: Turkey
facility: Investigational Site Number 792019
city: Samsun
country: Turkey
facility: Investigational Site Number 792021
city: Sivas
country: Turkey
facility: Investigational Site Number 792026
city: Cherkasy
country: Ukraine
facility: Investigational Site Number 804004
city: Kharkiv
country: Ukraine
facility: Investigational Site Number 804001
city: Lviv
country: Ukraine
facility: Investigational Site Number 804005
city: Zaporozhie
country: Ukraine
facility: Investigational Site Number 804003
city: Bournemouth
country: United Kingdom
facility: Investigational Site Number 826008
city: Bradford
country: United Kingdom
facility: Investigational Site Number 826007
city: Craigavon
country: United Kingdom
facility: Investigational Site Number 826001
city: East Kilbride
country: United Kingdom
facility: Investigational Site Number 826005
city: Hull
country: United Kingdom
facility: Investigational Site Number 826002
city: Manchester
country: United Kingdom
facility: Investigational Site Number 826006
city: St Leonards
country: United Kingdom
facility: Investigational Site Number 826003
city: Hanoi
country: Vietnam
facility: Investigational Site Number 704006
city: Ho Chi Minh City
country: Vietnam
facility: Investigational Site Number 704001
city: Ho Chi Minh City
country: Vietnam
facility: Investigational Site Number 704003
city: Ho Chi Minh City
country: Vietnam
facility: Investigational Site Number 704004
city: Ho Chi Minh City
country: Vietnam
facility: Investigational Site Number 704005
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References:
citation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Gaudin C, Fanouillere K, Moryusef A, Wiviott SD, Sabatine MS. Design and rationale of the treatment of acute coronary syndromes with otamixaban trial: a double-blind triple-dummy 2-stage randomized trial comparing otamixaban to unfractionated heparin and eptifibatide in non-ST-segment elevation acute coronary syndromes with a planned early invasive strategy. Am Heart J. 2012 Dec;164(6):817-24.e13. doi: 10.1016/j.ahj.2012.10.001. Epub 2012 Nov 7.
citation: Steg PG, Mehta SR, Pollack CV Jr, Bode C, Cohen M, French WJ, Hoekstra J, Rao SV, Ruzyllo W, Ruiz-Nodar JM, Sabate M, Widimsky P, Kiss RG, Navarro Estrada JL, Hod H, Kerkar P, Guneri S, Sezer M, Ruda M, Nicolau JC, Cavallini C, Ebrahim I, Petrov I, Kim JH, Jeong MH, Ramos Lopez GA, Laanmets P, Kovar F, Gaudin C, Fanouillere KC, Minini P, Hoffman EB, Moryusef A, Wiviott SD, Sabatine MS; TAO Investigators. Anticoagulation with otamixaban and ischemic events in non-ST-segment elevation acute coronary syndromes: the TAO randomized clinical trial. JAMA. 2013 Sep 18;310(11):1145-55. doi: 10.1001/jama.2013.277165.
citation: Abtan J, Wiviott SD, Sorbets E, Popovic B, Elbez Y, Mehta SR, Sabatine MS, Bode C, Pollack CV, Cohen M, Moccetti T, Laanmets P, Faxon D, Okreglicki A, Ducrocq G, Steg PG; TAO investigators. Prevalence, clinical determinants and prognostic implications of coronary procedural complications of percutaneous coronary intervention in non-ST-segment elevation myocardial infarction: Insights from the contemporary multinational TAO trial. Arch Cardiovasc Dis. 2021 Mar;114(3):187-196. doi: 10.1016/j.acvd.2020.09.005. Epub 2021 Jan 29.
citation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Petrauskiene B, Henry P, Dorobantu M, French WJ, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Sex Differences in Ischemic and Bleeding Outcomes in Patients With Non-ST-Segment-Elevation Acute Coronary Syndrome Undergoing Percutaneous Coronary Intervention: Insights From the TAO Trial. Circ Cardiovasc Interv. 2021 Jan;14(1):e009759. doi: 10.1161/CIRCINTERVENTIONS.120.009759. Epub 2021 Jan 12.
citation: Dillinger JG, Ducrocq G, Elbez Y, Cohen M, Bode C, Pollack C Jr, Nicolau JC, Henry P, Kedev S, Wiviott SD, Sabatine MS, Mehta SR, Steg PG. Activated Clotting Time to Guide Heparin Dosing in Non-ST-Segment-Elevation Acute Coronary Syndrome Patients Undergoing Percutaneous Coronary Intervention and Treated With IIb/IIIa Inhibitors: Impact on Ischemic and Bleeding Outcomes: Insights From the TAO Trial. Circ Cardiovasc Interv. 2018 Jun;11(6):e006084. doi: 10.1161/CIRCINTERVENTIONS.118.006084.