Clinical trial NCT00329238: Secondary Prevention of Venous Thrombo Embolism (VTE).
Official title: A Phase III, Randomised, Multicenter, Double-blind, Parallel-group, Active Controlled Study to Evaluate the Efficacy and Safety of Oral Dabigatran Etexilate (150 mg Bid) Compared to Warfarin (INR 2.0-3.0) for the Secondary Prevention of Venous Thromboembolism.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thromboembolism
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2006-05-24
Enrollment: 2867
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: The general aim of this study is to determine the comparative safety and efficacy of dabigatran etexilate administered orally and warfarin (International Normalized Ratio (INR) of 2.0-3.0) for the long-term treatment and secondary prevention of symptomatic venous thromboembolism in patients who have been successfully treated with standard doses of an approved anticoagulant for three to twelve months for confirmed acute symptomatic Venous Thrombo-embolism.


Eligibility criteria: Inclusion criteria:

Inclusion_Criteria

* Acute symptomatic deep vein thrombosis (DVT)
* Pulmonary embolism (PE) 3-12 months prior to screening, which has been documented by objective testing

Exclusion criteria:

Exclusion_Criteria

* Symptomatic DVT or PE at screening Interruption of anticoagulant therapy for 2 or more weeks during the 3-12 months of treatment for the prior VTE.
* Patients who in the investigators judgement are perceived as having an excessive risk of bleeding Elevated Aspartate aminotransferase (AST) or Alanine tranminase (ALT) \> 2x ULN
* Severe renal impairment (estimated creatinine clearance \<= 30 ml/min)

Primary outcomes:
measure: Composite of Recurrent VTE or VTE Death at 36 Months
timeFrame: 36 months
measure: Composite of Recurrent VTE or VTE Death at 18 Months
timeFrame: 18 months
Secondary outcomes:
measure: Composite of Recurrent VTE or All Cause Death at 36 Months
timeFrame: 36 months
measure: Composite of Recurrent VTE or All Cause Death at 18 Months
timeFrame: 18 months
measure: Deep Vein Thrombosis (DVT) at 36 Months
timeFrame: 36 months
measure: DVT at 18 Months
timeFrame: 18 months
measure: Symptomatic Pulmonary Embolism (PE) at 36 Months
timeFrame: 36 months
measure: Symptomatic Pulmonary Embolism (PE) at 18 Months
timeFrame: 18 months
measure: Deaths Related to VTE at 36 Months
timeFrame: 36 months
measure: Deaths Related to VTE at 18 Months
timeFrame: 18 months
measure: Deaths of All Causes at 36 Months
timeFrame: 36 months
measure: Deaths of All Causes at 18 Months
timeFrame: 18 months
measure: Number of Participants With Bleeding Events
timeFrame: first intake of study drug until 6 days following last intake of study drug
measure: Laboratory Analysis
timeFrame: 18 months + 30 days follow up
measure: Number of Participants With Definite Acute Coronary Syndrome (ACS)
timeFrame: day of first study drug intake until last day of study drug intake; from the day after last intake of study drug until trial termination
Other outcomes:
Locations:
city: Mobile
country: United States
facility: 1160.47.01035 Boehringer Ingelheim Investigational Site
state: Alabama
city: Hartford
country: United States
facility: 1160.47.01056 Boehringer Ingelheim Investigational Site
state: Connecticut
city: Clearwater
country: United States
facility: 1160.47.01044 Boehringer Ingelheim Investigational Site
state: Florida
city: Augusta
country: United States
facility: 1160.47.01019 Boehringer Ingelheim Investigational Site
state: Georgia
city: Decatur
country: United States
facility: 1160.47.01008 Boehringer Ingelheim Investigational Site
state: Georgia
city: Baltimore
country: United States
facility: 1160.47.01014 Boehringer Ingelheim Investigational Site
state: Maryland
city: Roxbury Crossing
country: United States
facility: 1160.47.01018 Boehringer Ingelheim Investigational Site
state: Massachusetts
city: Detroit
country: United States
facility: 1160.47.01023 Boehringer Ingelheim Investigational Site
state: Michigan
city: St. Louis Park
country: United States
facility: 1160.47.01009 Boehringer Ingelheim Investigational Site
state: Minnesota
city: Lebanon
country: United States
facility: 1160.47.01031 Boehringer Ingelheim Investigational Site
state: New Hampshire
city: Albuquerque
country: United States
facility: 1160.47.01036 Boehringer Ingelheim Investigational Site
state: New Mexico
city: Chapel Hill
country: United States
facility: 1160.47.01027 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: 1160.47.01039 Boehringer Ingelheim Investigational Site
state: North Carolina
city: Grand Forks
country: United States
facility: 1160.47.01030 Boehringer Ingelheim Investigational Site
state: North Dakota
city: Toledo
country: United States
facility: 1160.47.01013 Boehringer Ingelheim Investigational Site
state: Ohio
city: Altoona
country: United States
facility: 1160.47.01052 Boehringer Ingelheim Investigational Site
state: Pennsylvania
city: Summerville
country: United States
facility: 1160.47.01055 Boehringer Ingelheim Investigational Site
state: South Carolina
city: Richmond
country: United States
facility: 1160.47.01017 Boehringer Ingelheim Investigational Site
state: Virginia
city: Adrogué
country: Argentina
facility: 1160.47.54017 Boehringer Ingelheim Investigational Site
city: Bahía Blanca
country: Argentina
facility: 1160.47.54015 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
facility: 1160.47.54001 Boehringer Ingelheim Investigational Site
city: Capital Federal
country: Argentina
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city: Capital Federal
country: Argentina
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city: Capital Federal
country: Argentina
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city: Capital Federal
country: Argentina
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city: Capital Federal
country: Argentina
facility: 1160.47.54010 Boehringer Ingelheim Investigational Site
city: La Plata
country: Argentina
facility: 1160.47.54016 Boehringer Ingelheim Investigational Site
city: Mar del Plata
country: Argentina
facility: 1160.47.54014 Boehringer Ingelheim Investigational Site
city: Quilmes
country: Argentina
facility: 1160.47.54013 Boehringer Ingelheim Investigational Site
city: Rosario
country: Argentina
facility: 1160.47.54011 Boehringer Ingelheim Investigational Site
city: Salta
country: Argentina
facility: 1160.47.54018 Boehringer Ingelheim Investigational Site
city: Santa Fe
country: Argentina
facility: 1160.47.54012 Boehringer Ingelheim Investigational Site
city: Wooloongabba
country: Australia
facility: 1160.47.61002 Princess Alexandra Hospital
state: Queensland
city: Bedford Park
country: Australia
facility: 1160.47.61004 Boehringer Ingelheim Investigational Site
state: South Australia
city: Box Hill
country: Australia
facility: 1160.47.61003 Boehringer Ingelheim Investigational Site
state: Victoria
city: Clayton
country: Australia
facility: 1160.47.61001 Boehringer Ingelheim Investigational Site
state: Victoria
city: Windsor
country: Australia
facility: 1160.47.61006 Boehringer Ingelheim Investigational Site
state: Victoria
city: Perth
country: Australia
facility: 1160.47.61005 Boehringer Ingelheim Investigational Site
state: Western Australia
city: Graz
country: Austria
facility: 1160.47.43001 Boehringer Ingelheim Investigational Site
city: Innsbruck
country: Austria
facility: 1160.47.43003 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.47.43002 Boehringer Ingelheim Investigational Site
city: Wien
country: Austria
facility: 1160.47.43004 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1160.47.32001 Boehringer Ingelheim Investigational Site
city: Bruxelles
country: Belgium
facility: 1160.47.32002 Boehringer Ingelheim Investigational Site
city: Leuven
country: Belgium
facility: 1160.47.32005 Boehringer Ingelheim Investigational Site
city: Liège
country: Belgium
facility: 1160.47.32004 Boehringer Ingelheim Investigational Site
city: Brasília
country: Brazil
facility: 1160.47.55010 Boehringer Ingelheim Investigational Site
city: Campinas - SP
country: Brazil
facility: 1160.47.55007 Boehringer Ingelheim Investigational Site
city: Curitiba
country: Brazil
facility: 1160.47.55014 Boehringer Ingelheim Investigational Site
city: Juvene - Paraná -
country: Brazil
facility: 1160.47.55017 Boehringer Ingelheim Investigational Site
city: pTO aLEGRE
country: Brazil
facility: 1160.47.55012 Boehringer Ingelheim Investigational Site
city: Rio de Janeiro - RJ
country: Brazil
facility: 1160.47.55016 Boehringer Ingelheim Investigational Site
city: São Bernardo do Campo
country: Brazil
facility: 1160.47.55018 Boehringer Ingelheim Investigational Site
city: São José do Rio Preto
country: Brazil
facility: 1160.47.55005 Boehringer Ingelheim Investigational Site
city: Plovdiv
country: Bulgaria
facility: 1160.47.35910 Boehringer Ingelheim Investigational Site
city: Rousse
country: Bulgaria
facility: 1160.47.35908 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.47.35901 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.47.35903 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.47.35904 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.47.35906 Boehringer Ingelheim Investigational Site
city: Sofia
country: Bulgaria
facility: 1160.47.35907 Boehringer Ingelheim Investigational Site
city: Varna
country: Bulgaria
facility: 1160.47.35905 Boehringer Ingelheim Investigational Site
city: Edmonton
country: Canada
facility: 1160.47.02006 Boehringer Ingelheim Investigational Site
state: Alberta
city: Edmonton
country: Canada
facility: 1160.47.02013 Boehringer Ingelheim Investigational Site
state: Alberta
city: Victoria
country: Canada
facility: 1160.47.02021 Boehringer Ingelheim Investigational Site
state: British Columbia
city: Saint Johns
country: Canada
facility: 1160.47.02004 Boehringer Ingelheim Investigational Site
state: New Brunswick
city: Halifax
country: Canada
facility: 1160.47.02001 Boehringer Ingelheim Investigational Site
state: Nova Scotia
city: Hamilton
country: Canada
facility: 1160.47.02002 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.47.02005 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.47.02010 Boehringer Ingelheim Investigational Site
state: Ontario
city: Hamilton
country: Canada
facility: 1160.47.02022 Boehringer Ingelheim Investigational Site
state: Ontario
city: Ottawa
country: Canada
facility: 1160.47.02015 Boehringer Ingelheim Investigational Site
state: Ontario
city: Toronto
country: Canada
facility: 1160.47.02019 Boehringer Ingelheim Investigational Site
state: Ontario
city: Montreal
country: Canada
facility: 1160.47.02008 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.47.02009 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.47.02014 Boehringer Ingelheim Investigational Site
state: Quebec
city: Montreal
country: Canada
facility: 1160.47.02017 Boehringer Ingelheim Investigational Site
state: Quebec
city: Beijing
country: China
facility: 1160.47.86001 Boehringer Ingelheim Investigational Site
city: Beijing
country: China
facility: 1160.47.86015 Boehringer Ingelheim Investigational Site
city: Chengdu
country: China
facility: 1160.47.86014 Boehringer Ingelheim Investigational Site
city: Guangzhou
country: China
facility: 1160.47.86012 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1160.47.86009 Boehringer Ingelheim Investigational Site
city: Hangzhou
country: China
facility: 1160.47.86010 Boehringer Ingelheim Investigational Site
city: Nanjing
country: China
facility: 1160.47.86013 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86002 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86003 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86004 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86005 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86006 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86007 Boehringer Ingelheim Investigational Site
city: Shanghai
country: China
facility: 1160.47.86016 Boehringer Ingelheim Investigational Site
city: Shijiazhuang
country: China
facility: 1160.47.86011 Boehringer Ingelheim Investigational Site
city: Brno
country: Czech Republic
facility: 1160.47.42001 Boehringer Ingelheim Investigational Site
city: Hradec Kralove
country: Czech Republic
facility: 1160.47.42002 Boehringer Ingelheim Investigational Site
city: Hranice
country: Czech Republic
facility: 1160.47.42011 Boehringer Ingelheim Investigational Site
city: Liberec
country: Czech Republic
facility: 1160.47.42012 Boehringer Ingelheim Investigational Site
city: Novy Jicin
country: Czech Republic
facility: 1160.47.42015 Boehringer Ingelheim Investigational Site
city: Ostrava-Vitkovice
country: Czech Republic
facility: 1160.47.42005 Boehringer Ingelheim Investigational Site
city: Praha 2
country: Czech Republic
facility: 1160.47.42004 Boehringer Ingelheim Investigational Site
city: Tabor
country: Czech Republic
facility: 1160.47.42014 Boehringer Ingelheim Investigational Site
city: Usti nad Labem
country: Czech Republic
facility: 1160.47.42010 Boehringer Ingelheim Investigational Site
city: Zlin
country: Czech Republic
facility: 1160.47.42007 Boehringer Ingelheim Investigational Site
city: Esbjerg
country: Denmark
facility: 1160.47.45008 Boehringer Ingelheim Investigational Site
city: Holbæk
country: Denmark
facility: 1160.47.45009 Boehringer Ingelheim Investigational Site
city: Kolding
country: Denmark
facility: 1160.47.45002 Boehringer Ingelheim Investigational Site
city: København NV
country: Denmark
facility: 1160.47.45004 Boehringer Ingelheim Investigational Site
city: København S
country: Denmark
facility: 1160.47.45007 Boehringer Ingelheim Investigational Site
city: Slagelse
country: Denmark
facility: 1160.47.45006 Boehringer Ingelheim Investigational Site
city: Espoo
country: Finland
facility: 1160.47.35804 Boehringer Ingelheim Investigational Site
city: Helsinki
country: Finland
facility: 1160.47.35801 Boehringer Ingelheim Investigational Site
city: Jyväskylä
country: Finland
facility: 1160.47.35802 Boehringer Ingelheim Investigational Site
city: Kuopio
country: Finland
facility: 1160.47.35805 Boehringer Ingelheim Investigational Site
city: Tampere
country: Finland
facility: 1160.47.35803 Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301A Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301B Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301C Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301D Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301E Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301F Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301H Boehringer Ingelheim Investigational Site
city: Brest Cedex
country: France
facility: 1160.47.3301I Boehringer Ingelheim Investigational Site
city: Lorient
country: France
facility: 1160.47.3302A Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.47.3303A Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.47.3303B Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.47.3303C Boehringer Ingelheim Investigational Site
city: St Etienne Cedex 2
country: France
facility: 1160.47.3303D Boehringer Ingelheim Investigational Site
city: Vandoeuvre les Nancy
country: France
facility: 1160.47.3308A Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1160.47.49017 Boehringer Ingelheim Investigational Site
city: Dresden
country: Germany
facility: 1160.47.49018 Boehringer Ingelheim Investigational Site
city: Köln
country: Germany
facility: 1160.47.49003 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1160.47.49005 Boehringer Ingelheim Investigational Site
city: Mannheim
country: Germany
facility: 1160.47.49006 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.47.49007 Boehringer Ingelheim Investigational Site
city: München
country: Germany
facility: 1160.47.49008 Boehringer Ingelheim Investigational Site
city: Püttlingen
country: Germany
facility: 1160.47.49009 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.47.30001 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.47.30006 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.47.30007 Boehringer Ingelheim Investigational Site
city: Athens
country: Greece
facility: 1160.47.30009 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.47.36001 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.47.36006 Boehringer Ingelheim Investigational Site
city: Budapest
country: Hungary
facility: 1160.47.36007 Boehringer Ingelheim Investigational Site
city: Debrecen
country: Hungary
facility: 1160.47.36002 Boehringer Ingelheim Investigational Site
city: Gyula
country: Hungary
facility: 1160.47.36012 Boehringer Ingelheim Investigational Site
city: Miskolc
country: Hungary
facility: 1160.47.36004 Boehringer Ingelheim Investigational Site
city: Pecs
country: Hungary
facility: 1160.47.36003 Boehringer Ingelheim Investigational Site
city: Szombathely
country: Hungary
facility: 1160.47.36011 Boehringer Ingelheim Investigational Site
city: Székesfehérvár
country: Hungary
facility: 1160.47.36010 Boehringer Ingelheim Investigational Site
city: Ahmedabad
country: India
facility: 1160.47.91002 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1160.47.91011 Boehringer Ingelheim Investigational Site
city: Bangalore
country: India
facility: 1160.47.91015 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1160.47.91012 Boehringer Ingelheim Investigational Site
city: Chennai
country: India
facility: 1160.47.91017 Boehringer Ingelheim Investigational Site
city: Madurai
country: India
facility: 1160.47.91009 Boehringer Ingelheim Investigational Site
city: Mysore
country: India
facility: 1160.47.91007 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1160.47.91003 Boehringer Ingelheim Investigational Site
city: new Delhi
country: India
facility: 1160.47.91006 Boehringer Ingelheim Investigational Site
city: New Delhi
country: India
facility: 1160.47.91010 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.47.91001 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.47.91005 Boehringer Ingelheim Investigational Site
city: Pune
country: India
facility: 1160.47.91008 Boehringer Ingelheim Investigational Site
city: Trivandrum
country: India
facility: 1160.47.91014 Boehringer Ingelheim Investigational Site
city: Vadodara
country: India
facility: 1160.47.91004 Boehringer Ingelheim Investigational Site
city: Afula
country: Israel
facility: 1160.47.97202 Boehringer Ingelheim Investigational Site
city: Ashkelon
country: Israel
facility: 1160.47.97207 Boehringer Ingelheim Investigational Site
city: Haifa
country: Israel
facility: 1160.47.97211 Boehringer Ingelheim Investigational Site
city: Holon
country: Israel
facility: 1160.47.97203 Boehringer Ingelheim Investigational Site
city: Kfar Saba
country: Israel
facility: 1160.47.97205 Boehringer Ingelheim Investigational Site
city: Petach Tikva
country: Israel
facility: 1160.47.97206 Boehringer Ingelheim Investigational Site
city: Rehovot
country: Israel
facility: 1160.47.97208 Boehringer Ingelheim Investigational Site
city: Tel Aviv
country: Israel
facility: 1160.47.97210 Boehringer Ingelheim Investigational Site
city: Tel Hashomer
country: Israel
facility: 1160.47.97204 Boehringer Ingelheim Investigational Site
city: Zerifin
country: Israel
facility: 1160.47.97201 Boehringer Ingelheim Investigational Site
city: Bologna
country: Italy
facility: 1160.47.39003 Boehringer Ingelheim Investigational Site
city: Cremona
country: Italy
facility: 1160.47.39004 Boehringer Ingelheim Investigational Site
city: Genova
country: Italy
facility: 1160.47.39006 Boehringer Ingelheim Investigational Site
city: Milano
country: Italy
facility: 1160.47.39008 Boehringer Ingelheim Investigational Site
city: Reggio Emilia
country: Italy
facility: 1160.47.39007 Boehringer Ingelheim Investigational Site
city: Udine
country: Italy
facility: 1160.47.39009 Boehringer Ingelheim Investigational Site
city: Vittorio Veneto
country: Italy
facility: 1160.47.39005 Boehringer Ingelheim Investigational Site
city: Chihuahua
country: Mexico
facility: 1160.47.52036 Boehringer Ingelheim Investigational Site
city: Culiacan
country: Mexico
facility: 1160.47.52039 Boehringer Ingelheim Investigational Site
city: Guadalajara, Jal.
country: Mexico
facility: 1160.47.52030 Boehringer Ingelheim Investigational Site
city: Monterrey
country: Mexico
facility: 1160.47.52027 Boehringer Ingelheim Investigational Site
city: San Luis Potosí
country: Mexico
facility: 1160.47.52034 Boehringer Ingelheim Investigational Site
city: Amersfoort
country: Netherlands
facility: 1160.47.31001 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.47.31006 Boehringer Ingelheim Investigational Site
city: Amsterdam
country: Netherlands
facility: 1160.47.31007 Boehringer Ingelheim Investigational Site
city: Den Bosch
country: Netherlands
facility: 1160.47.31010 Boehringer Ingelheim Investigational Site
city: Heerlen
country: Netherlands
facility: 1160.47.31014 Boehringer Ingelheim Investigational Site
city: Maastricht
country: Netherlands
facility: 1160.47.31005 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.47.31004 Boehringer Ingelheim Investigational Site
city: Rotterdam
country: Netherlands
facility: 1160.47.31009 Boehringer Ingelheim Investigational Site
city: Christchurch
country: New Zealand
facility: 1160.47.64004 Boehringer Ingelheim Investigational Site
city: Grafton
country: New Zealand
facility: 1160.47.64003 Boehringer Ingelheim Investigational Site
city: Otahuhu
country: New Zealand
facility: 1160.47.64002 Boehringer Ingelheim Investigational Site
city: Takapuna Auckland 9
country: New Zealand
facility: 1160.47.64001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.47.47001 Boehringer Ingelheim Investigational Site
city: Oslo
country: Norway
facility: 1160.47.47004 Boehringer Ingelheim Investigational Site
city: Rud
country: Norway
facility: 1160.47.47003 Boehringer Ingelheim Investigational Site
city: Trondheim
country: Norway
facility: 1160.47.47005 Boehringer Ingelheim Investigational Site
city: Kielce
country: Poland
facility: 1160.47.48004 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.47.48005 Boehringer Ingelheim Investigational Site
city: Krakow
country: Poland
facility: 1160.47.48007 Boehringer Ingelheim Investigational Site
city: Poznan
country: Poland
facility: 1160.47.48003 Boehringer Ingelheim Investigational Site
city: Warsaw
country: Poland
facility: 1160.47.48006 Boehringer Ingelheim Investigational Site
city: Almada
country: Portugal
facility: 1160.47.35104 Boehringer Ingelheim Investigational Site
city: Coimbra
country: Portugal
facility: 1160.47.35109 Boehringer Ingelheim Investigational Site
city: Covilhã
country: Portugal
facility: 1160.47.35107 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1160.47.35101 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1160.47.35102 Boehringer Ingelheim Investigational Site
city: Lisboa
country: Portugal
facility: 1160.47.35105 Boehringer Ingelheim Investigational Site
city: Belgorod
country: Russian Federation
facility: 1160.47.07022 Boehringer Ingelheim Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: 1160.47.07011 Boehringer Ingelheim Investigational Site
city: Chelyabinsk
country: Russian Federation
facility: 1160.47.07021 Boehringer Ingelheim Investigational Site
city: Ekaterinburg
country: Russian Federation
facility: 1160.47.07007 Boehringer Ingelheim Investigational Site
city: Krasnodar
country: Russian Federation
facility: 1160.47.07016 Boehringer Ingelheim Investigational Site
city: Kursk
country: Russian Federation
facility: 1160.47.07004 Boehringer Ingelheim Investigational Site
city: Novosibirsk
country: Russian Federation
facility: 1160.47.07010 Boehringer Ingelheim Investigational Site
city: Omsk
country: Russian Federation
facility: 1160.47.07020 Boehringer Ingelheim Investigational Site
city: Pskov
country: Russian Federation
facility: 1160.47.07018 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.47.07009 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.47.07023 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.47.07024 Boehringer Ingelheim Investigational Site
city: Rostov-na-Donu
country: Russian Federation
facility: 1160.47.07025 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1160.47.07001 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1160.47.07002 Boehringer Ingelheim Investigational Site
city: St. Petersburg
country: Russian Federation
facility: 1160.47.07017 Boehringer Ingelheim Investigational Site
city: Tyumen
country: Russian Federation
facility: 1160.47.07019 Boehringer Ingelheim Investigational Site
city: Ufa
country: Russian Federation
facility: 1160.47.07014 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.47.07005 Boehringer Ingelheim Investigational Site
city: Yaroslavl
country: Russian Federation
facility: 1160.47.07006 Boehringer Ingelheim Investigational Site
city: Banska Bystrica
country: Slovakia
facility: 1160.47.42107 Boehringer Ingelheim Investigational Site
city: Lucenec
country: Slovakia
facility: 1160.47.42106 Boehringer Ingelheim Investigational Site
city: Nitra
country: Slovakia
facility: 1160.47.42102 Boehringer Ingelheim Investigational Site
city: Nove Zamky
country: Slovakia
facility: 1160.47.42103 Boehringer Ingelheim Investigational Site
city: Zilina
country: Slovakia
facility: 1160.47.42104 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.47.27001 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.47.27002 Boehringer Ingelheim Investigational Site
city: Johannesburg
country: South Africa
facility: 1160.47.27006 Boehringer Ingelheim Investigational Site
city: Pretoria
country: South Africa
facility: 1160.47.27007
city: Randburg
country: South Africa
facility: 1160.47.27003 Boehringer Ingelheim Investigational Site
city: Roodepoort
country: South Africa
facility: 1160.47.27005 Boehringer Ingelheim Investigational Site
city: Alicante
country: Spain
facility: 1160.47.34006 Boehringer Ingelheim Investigational Site
city: Badalona (Barcelona)
country: Spain
facility: 1160.47.34012 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.47.34001 Boehringer Ingelheim Investigational Site
city: Barcelona
country: Spain
facility: 1160.47.34002 Boehringer Ingelheim Investigational Site
city: Cartagena. Murcia
country: Spain
facility: 1160.47.34007 Boehringer Ingelheim Investigational Site
city: Cuenca
country: Spain
facility: 1160.47.34003 Boehringer Ingelheim Investigational Site
city: Madrid
country: Spain
facility: 1160.47.34009 Boehringer Ingelheim Investigational Site
city: Santander
country: Spain
facility: 1160.47.34004 Boehringer Ingelheim Investigational Site
city: Valencia
country: Spain
facility: 1160.47.34011 Boehringer Ingelheim Investigational Site
city: Göteborg
country: Sweden
facility: 1160.47.46002 Boehringer Ingelheim Investigational Site
city: Jönköping
country: Sweden
facility: 1160.47.46006 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.47.46001 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.47.46007 Boehringer Ingelheim Investigational Site
city: Stockholm
country: Sweden
facility: 1160.47.46008 Boehringer Ingelheim Investigational Site
city: Sundsvall
country: Sweden
facility: 1160.47.46005 Boehringer Ingelheim Investigational Site
city: Uppsala
country: Sweden
facility: 1160.47.46003 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.47.90003 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.47.90004 Boehringer Ingelheim Investigational Site
city: Ankara
country: Turkey
facility: 1160.47.90005 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.47.90001 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.47.90002 Boehringer Ingelheim Investigational Site
city: Istanbul
country: Turkey
facility: 1160.47.90007 Boehringer Ingelheim Investigational Site
city: Izmir
country: Turkey
facility: 1160.47.90006 Boehringer Ingelheim Investigational Site
city: Kharkov
country: Ukraine
facility: 1160.47.38002 Boehringer Ingelheim Investigational Site
city: Kiev
country: Ukraine
facility: 1160.47.38006 Boehringer Ingelheim Investigational Site
city: Vinnitsa
country: Ukraine
facility: 1160.47.38005 Boehringer Ingelheim Investigational Site
city: Zaporozhye
country: Ukraine
facility: 1160.47.38003 Boehringer Ingelheim Investigational Site
city: Headington, Oxford
country: United Kingdom
facility: 1160.47.44005 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.47.44009 Boehringer Ingelheim Investigational Site
city: London
country: United Kingdom
facility: 1160.47.44011 Boehringer Ingelheim Investigational Site
city: Newcastle upon Tyne
country: United Kingdom
facility: 1160.47.44006 Boehringer Ingelheim Investigational Site
city: Sheffield
country: United Kingdom
facility: 1160.47.44012 Boehringer Ingelheim Investigational Site
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
citation: Goldhaber SZ, Eriksson H, Kakkar A, Schellong S, Feuring M, Fraessdorf M, Kreuzer J, Schueler E, Schulman S. Efficacy of dabigatran versus warfarin in patients with acute venous thromboembolism in the presence of thrombophilia: Findings from RE-COVER(R), RE-COVER II, and RE-MEDY. Vasc Med. 2016 Dec;21(6):506-514. doi: 10.1177/1358863X16668588. Epub 2016 Nov 1.
citation: Majeed A, Hwang HG, Connolly SJ, Eikelboom JW, Ezekowitz MD, Wallentin L, Brueckmann M, Fraessdorf M, Yusuf S, Schulman S. Management and outcomes of major bleeding during treatment with dabigatran or warfarin. Circulation. 2013 Nov 19;128(21):2325-32. doi: 10.1161/CIRCULATIONAHA.113.002332. Epub 2013 Sep 30.
citation: Schulman S, Kearon C, Kakkar AK, Schellong S, Eriksson H, Baanstra D, Kvamme AM, Friedman J, Mismetti P, Goldhaber SZ; RE-MEDY Trial Investigators; RE-SONATE Trial Investigators. Extended use of dabigatran, warfarin, or placebo in venous thromboembolism. N Engl J Med. 2013 Feb 21;368(8):709-18. doi: 10.1056/NEJMoa1113697.