Clinical trial NCT00457002: Study of Apixaban for the Prevention of Thrombosis-related Events in Patients With Acute Medical Illness
Official title: A Phase 3 Randomized, Double-Blind, Parallel-group, Multi-center Study of the Safety and Efficacy of Apixaban for Prophylaxis of Venous Thromboembolism in Acutely Ill Medical Subjects During and Following Hospitalization.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Venous Thrombosis
Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism with acutely ill hospitalized patients
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2007-04-05
Enrollment: 6758
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur within patients hospitalized for acute medical illness, and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.


Eligibility criteria: Inclusion Criteria:

* men and non-pregnant, non-breastfeeding women
* 40 years or older
* hospitalized with congestive heart failure or acute respiratory failure
* infection (without septic shock)
* acute rheumatic disorder
* inflammatory bowel disease

Exclusion Criteria:

* patients with venous thromboembolism (VTE)
* active bleeding or at high risk of bleeding
* unable to take oral medication
* with diseases requiring ongoing treatment with anticoagulants or antiplatelets other than aspirin at a dose ≤ 165 mg/day.

Primary outcomes:
measure: Incidence of Composite of Adjudicated Total Venous Thromboembolism (VTE) and VTE-related Death During the Intended Treatment Period - Primary Efficacy Population
timeFrame: Intended Treatment Period
measure: Incidence of Major Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
measure: Incidence of Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
measure: Incidence of Composite of Major or Clinically Relevant Non-Major (CRNM) Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1, first dose of study drug, to last dose of study drug plus 2 days
measure: Incidence of All Bleeding During the Treatment Period in Treated Participants
timeFrame: Day 1, first dose of drug to last dose of drug plus 2 days
Secondary outcomes:
measure: Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Key Secondary Efficacy Evaluable Participants
timeFrame: Day 1 to last dose of parenteral study drug plus 1 day
measure: Incidence of Adjudicated Total VTE and VTE-Related Death During Parenteral Treatment in Secondary Efficacy Evaluable Participants
timeFrame: Day 1 to last dose of parenteral study drug plus 1 day
measure: Incidence of Adjudicated Total VTE or All-Cause Death With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Proximal DVT, Non-Fatal PE or All-Cause Death With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Proximal DVT, Non-Fatal PE or VTE-Related Death, With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated VTE-Related Death With Onset During the Intended Treatment Period in Randomized Participants
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Symptomatic VTE or All-Cause Death With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Symptomatic Adjudicated VTE or VTE-Related Death With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of All VTE or Major Bleeding or All-Cause Death During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated PE With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Non-Fatal PE With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Symptomatic DVT With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Proximal DVT With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Symptomatic Distal DVT With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Symptomatic Proximal DVT With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Incidence of Adjudicated Asymptomatic Proximal DVT With Onset During the Intended Treatment Period
timeFrame: Intended Treatment Period
measure: Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Bleeding AEs, Deaths, and Discontinuations Due to AEs During the Treatment Period in Treated Participants
timeFrame: Day 1, first dose of study drug, to last dose of study drug plus 2 days (AEs), plus 30 days (SAEs, Deaths)
measure: Mean Change From Baseline in Diastolic Blood Pressure in Treated Participants During Treatment Period
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Mean Change From Baseline in Systolic Blood Pressure in Treated Participants During Treatment Period
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Mean Change From Baseline in Heart Rate in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Number of Participants With Marked Abnormalities in Hematology Laboratory Tests During Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Number of Participants With Marked Abnormalities in Electrolyte Laboratory Tests During Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Number of Participants With Marked Abnormalities in Kidney and Liver Function Laboratory Tests During the Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Number of Participants With Marked Abnormalities in Glucose, Creatine Kinase, Uric Acid, and Total Protein Laboratory Tests During the Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Incidence of Events of Special Interest of Adjudicated Myocardial Infarction, Stroke, and Thrombocytopenia During the Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
measure: Number of Participants With Events of Special Interest for Liver Function and Neurology During Treatment Period in Treated Participants With Available Measurements
timeFrame: Day 1 to last dose of study drug plus 2 days (AEs) and plus 30 days (SAEs)
measure: Number of Participants With Liver-Related Elevations During the Treatment Period in Treated Participants
timeFrame: Day 1 to last dose of study drug plus 2 days
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University Of Alabama At Birmingham Hospital
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, Llc
state: Alabama
city: Phoenix
country: United States
facility: Arizona Pulmonary Specialists, Ltd.
state: Arizona
city: Scottsdale
country: United States
facility: Az Pulmonary Specialists Ltd
state: Arizona
city: Fort Smith
country: United States
facility: Fort Smith Lung Center
state: Arkansas
city: La Jolla
country: United States
facility: Scripps Clinic/Scripps Health And Green Hospital
state: California
city: Long Beach
country: United States
facility: Va Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Univ. Of Southern Calif. /Norris Comprehensive Cancer Center
state: California
city: Oakland
country: United States
facility: Dr. Felt Medical Office
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale University School Of Medicine
state: Connecticut
city: Norwalk
country: United States
facility: Norwalk Hospital
state: Connecticut
city: Washington
country: United States
facility: George Washington University
state: District of Columbia
city: Celebration
country: United States
facility: Florida Hospital Celebration Health
state: Florida
city: Clearwater
country: United States
facility: Research Alliance, Inc.
state: Florida
city: Jacksonville
country: United States
facility: Jacksonville Center For Clinical Research
state: Florida
city: Pensacola
country: United States
facility: Pensacola Lung Group
state: Florida
city: Vero Beach
country: United States
facility: Indian River Med. Ctr.
state: Florida
city: Atlanta
country: United States
facility: Atlanta Institute For Medical Research, Inc
state: Georgia
city: Atlanta
country: United States
facility: Pulmonary & Critical Care Of Atlanta
state: Georgia
city: Idaho Falls
country: United States
facility: Idaho Falls Infectious Diseases, Pllc
state: Idaho
city: Oak Park
country: United States
facility: West Suburban Hospital
state: Illinois
city: Carmel
country: United States
facility: Infectious Disease Of Indiana Psc
state: Indiana
city: Topeka
country: United States
facility: Cotton-O-Neil Clinical Research Center
state: Kansas
city: Shreveport
country: United States
facility: Louisiana State University Health Sciences Center-Shreveport
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School Of Medicine
state: Maryland
city: Baltimore
country: United States
facility: Franklin Square Hospital
state: Maryland
city: Detriot
country: United States
facility: Henry Ford Hospital, Transplant Institute
state: Michigan
city: Columbia
country: United States
facility: University Of Missouri-Columbia
state: Missouri
city: Butte
country: United States
facility: Mercury Street Medical Group, Pllc
state: Montana
city: Omaha
country: United States
facility: Creighton University Medical Center
state: Nebraska
city: Mornstown
country: United States
facility: Morristown Memorial Hospital
state: New Jersey
city: Manhasset
country: United States
facility: North Shore University Hospital
state: New York
city: Staten Island
country: United States
facility: Staten Island University Hospital
state: New York
city: Asheville
country: United States
facility: Mission Hospital, Inc
state: North Carolina
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research
state: Oklahoma
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Hershey
country: United States
facility: The Milton S Hershey Medical Center Of Penn. State Univ.
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Orangeburg
country: United States
facility: Palmetto Nephrology Pa
state: South Carolina
city: Spartanburg
country: United States
facility: S. Carolina Pharmaceutical Research
state: South Carolina
city: Dallas
country: United States
facility: Texas Health Presbyterian Dallas
state: Texas
city: Houston
country: United States
facility: Michael E. De Bakey Veteran Affairs Medical Center
state: Texas
city: San Antonio
country: United States
facility: Sonterra Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Sonterra Clinical Research
state: Texas
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
city: Salt Lake City
country: United States
facility: University Of Utah Medical Center
state: Utah
city: Richmond
country: United States
facility: Mcguire Va Medical Center
state: Virginia
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Coronel Suarez
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Derqui-Pilar
country: Argentina
facility: Local Institution
state: Buenos Aires
city: La Plata
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Munro
country: Argentina
facility: Local Institution
state: Buenos Aires
city: San Martin
country: Argentina
facility: Local Institution
state: Buenos Aires
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: Rosario
country: Argentina
facility: Local Institution
state: Santa Fe
city: San Miguel De Tucuman
country: Argentina
facility: Local Institution
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Cordoba
country: Argentina
facility: Local Institution
city: Corrientes
country: Argentina
facility: Local Institution
city: Concord
country: Australia
facility: Local Institution
state: New South Wales
city: St Leonards
country: Australia
facility: Local Institution
state: New South Wales
city: Kippa Ring
country: Australia
facility: Local Institution
state: Queensland
city: Woolloongabba
country: Australia
facility: Local Institution
state: Queensland
city: Bedford Park
country: Australia
facility: Local Institution
state: South Australia
city: Woodville
country: Australia
facility: Local Institution
state: South Australia
city: Box Hill
country: Australia
facility: Local Institution
state: Victoria
city: Parkville
country: Australia
facility: Local Institution
state: Victoria
city: Ringwood East
country: Australia
facility: Local Institution
state: Victoria
city: Graz
country: Austria
facility: Local Institution
city: Wien
country: Austria
facility: Local Institution
city: Ottignies
country: Belgium
facility: Local Institution
state: Waals-Brabant
city: Antwerpen
country: Belgium
facility: Local Institution
city: Brasschaat
country: Belgium
facility: Local Institution
city: Bruxelles
country: Belgium
facility: Local Institution
city: Huy
country: Belgium
facility: Local Institution
city: Leuven
country: Belgium
facility: Local Institution
city: Belo Horizonte
country: Brazil
facility: Local Institution
state: Minas Gerais
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Curitiba
country: Brazil
facility: Local Institution
state: Parana
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Local Institution
state: Rio Grande Do Sul
city: Botucatu
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Campinas
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Jose Do Rio Preto
country: Brazil
facility: Local Institution
state: Sao Paulo
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Sao Paulo
country: Brazil
facility: Local Institution
city: Ajax
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Hamilton
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Windsor
country: Canada
facility: Local Institution
state: Ontario
city: Granby
country: Canada
facility: Local Institution
state: Quebec
city: Greenfield Park
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Montreal
country: Canada
facility: Local Institution
state: Quebec
city: Temuco
country: Chile
facility: Local Institution
state: Araucania
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Santiago
country: Chile
facility: Local Institution
state: Metropolitana
city: Rancagua
country: Chile
facility: Local Institution
state: Valparaiso
city: Bogota
country: Colombia
facility: Local Institution
city: Bucaramanga
country: Colombia
facility: Local Institution
city: Medellin
country: Colombia
facility: Local Institution
city: Brno
country: Czech Republic
facility: Local Institution
city: Jindrichuv Hradec
country: Czech Republic
facility: Local Institution
city: Kladno
country: Czech Republic
facility: Local Institution
city: Kyjov
country: Czech Republic
facility: Local Institution
city: Ostrava
country: Czech Republic
facility: Local Institution
city: Prague 2
country: Czech Republic
facility: Local Institution
city: Praha 1
country: Czech Republic
facility: Local Institution
city: Praha 5
country: Czech Republic
facility: Local Institution
city: Usti Nad Labem
country: Czech Republic
facility: Local Institution
city: Aalborg
country: Denmark
facility: Local Institution
city: Aarhus N
country: Denmark
facility: Local Institution
city: Arhus C
country: Denmark
facility: Local Institution
city: Frederiksberg
country: Denmark
facility: Local Institution
city: Glostrup
country: Denmark
facility: Local Institution
city: Hellerup
country: Denmark
facility: Local Institution
city: Herlev
country: Denmark
facility: Local Institution
city: Herning
country: Denmark
facility: Local Institution
city: Hvidovre
country: Denmark
facility: Local Institution
city: Odense
country: Denmark
facility: Local Institution
city: Randers No
country: Denmark
facility: Local Institution
city: Silkeborg
country: Denmark
facility: Local Institution
city: Bordeaux
country: France
facility: Local Institution
city: Brest Cedex
country: France
facility: Local Institution
city: Brest
country: France
facility: Local Institution
city: Dijon Cedex
country: France
facility: Local Institution
city: Grenoble Cedex 9
country: France
facility: Local Institution
city: Lille Cedex
country: France
facility: Local Institution
city: Nancy
country: France
facility: Local Institution
city: Nimes Cedex 9
country: France
facility: Local Institution
city: Paris Cedex 10
country: France
facility: Local Institution
city: Paris Cedex 15
country: France
facility: Local Institution
city: Saint Etienne Cedex 02
country: France
facility: Local Institution
city: Vernon
country: France
facility: Local Institution
city: Bonn
country: Germany
facility: Local Institution
city: Coburg
country: Germany
facility: Local Institution
city: Darmstadt
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Dresden
country: Germany
facility: Local Institution
city: Hannover
country: Germany
facility: Local Institution
city: Karlsbad
country: Germany
facility: Local Institution
city: Luebeck
country: Germany
facility: Local Institution
city: Mannheim
country: Germany
facility: Local Institution
city: Offenbach
country: Germany
facility: Local Institution
city: Witten
country: Germany
facility: Local Institution
city: Shatin, N.T.
country: Hong Kong
facility: Local Institution
city: Budapest
country: Hungary
facility: Local Institution
city: Debrecen
country: Hungary
facility: Local Institution
city: Dunaujvaros
country: Hungary
facility: Local Institution
city: Eger
country: Hungary
facility: Local Institution
city: Vishakapatnam
country: India
facility: Local Institution
state: Andhra-Pradesh
city: Hyderabad
country: India
facility: Local Institution
state: Andra Pradesh
city: Ahemdabad
country: India
facility: Local Institution
state: Gujarat
city: Bangalore
country: India
facility: Local Institution
state: Karnataka
city: Indore
country: India
facility: Local Institution
state: Madhya Pardesh
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Pune
country: India
facility: Local Institution
state: Maharashtra
city: Pune
country: India
facility: Local Institution
state: Maharastra
city: Ludhiana
country: India
facility: Local Institution
state: Punjab
city: Coimbatore
country: India
facility: Local Institution
state: Tamil Nadu
city: Madurai
country: India
facility: Local Institution
state: Tamil Nadu
city: Chennai
country: India
facility: Local Institution
state: Tamil-Nadu
city: Noida
country: India
facility: Local Institution
state: Uttar Pradesh
city: Ahmedabad
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Bangalore
country: India
facility: Local Institution
city: Hyderabad
country: India
facility: Local Institution
city: Mumbai
country: India
facility: Local Institution
city: New Delhi
country: India
facility: Local Institution
city: Afula
country: Israel
facility: Local Institution
city: Ashkelon
country: Israel
facility: Local Institution
city: Beer Sheva
country: Israel
facility: Local Institution
city: Haifa
country: Israel
facility: Local Institution
city: Petach Tikva
country: Israel
facility: Local Institution
city: Safed
country: Israel
facility: Local Institution
city: Tel Hashomer
country: Israel
facility: Local Institution
city: Tel-Aviv
country: Israel
facility: Local Institution
city: Zerifin
country: Israel
facility: Local Institution
city: Chieti Scalo
country: Italy
facility: Local Institution
city: Cremona
country: Italy
facility: Local Institution
city: Padua
country: Italy
facility: Local Institution
city: Piacenza
country: Italy
facility: Local Institution
city: Reggio Emilia
country: Italy
facility: Local Institution
city: Treviso
country: Italy
facility: Local Institution
city: Vicenza
country: Italy
facility: Local Institution
city: Guri-Si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-Do
city: Seongnam-Si
country: Korea, Republic of
facility: Local Institution
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Seoul
country: Korea, Republic of
facility: Local Institution
city: Suwon
country: Korea, Republic of
facility: Local Institution
city: Kubang Kerian
country: Malaysia
facility: Local Institution
state: Kelantan
city: Batu Caves
country: Malaysia
facility: Local Institution
state: Selangor
city: Johor Bahru
country: Malaysia
facility: Local Institution
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Mexico
country: Mexico
facility: Local Institution
state: Distrito Federal
city: Monterrey
country: Mexico
facility: Local Institution
state: Nuevo Leon
city: Xalapa
country: Mexico
facility: Local Institution
state: Veracruz
city: Merida
country: Mexico
facility: Local Institution
state: Yucatan
city: Queretaro
country: Mexico
facility: Local Institution
city: San Luis Potosi
country: Mexico
facility: Local Institution
city: Den Helder
country: Netherlands
facility: Local Institution
city: Kongsvinger
country: Norway
facility: Local Institution
city: La Victoria
country: Peru
facility: Local Institution
state: Lima
city: Arequipa
country: Peru
facility: Local Institution
city: Callao
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Lima
country: Peru
facility: Local Institution
city: Cagayan De Oro City
country: Philippines
facility: Local Institution
state: Misamis Oriental
city: Las Pinas
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Quezon City
country: Philippines
facility: Local Institution
city: Bydgoszcz
country: Poland
facility: Local Institution
city: Krakow
country: Poland
facility: Local Institution
city: Lodz
country: Poland
facility: Local Institution
city: Nowa Sol
country: Poland
facility: Local Institution
city: Poznan
country: Poland
facility: Local Institution
city: Skierniewice
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Warszawa
country: Poland
facility: Local Institution
city: Wejherowo
country: Poland
facility: Local Institution
city: Zielona Gora
country: Poland
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Moscow
country: Russian Federation
facility: Local Institution
city: Odintsovo
country: Russian Federation
facility: Local Institution
city: Podolsk
country: Russian Federation
facility: Local Institution
city: Ryazan
country: Russian Federation
facility: Local Institution
city: Saint Petersburg
country: Russian Federation
facility: Local Institution
city: Saint-Petersburg
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: Saratov
country: Russian Federation
facility: Local Institution
city: St Petersburg
country: Russian Federation
facility: Local Institution
city: St. Petersburg
country: Russian Federation
facility: Local Institution
city: St.Petersburg
country: Russian Federation
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Singapore
country: Singapore
facility: Local Institution
city: Bloemfontein
country: South Africa
facility: Local Institution
state: Free State
city: Johannesburg
country: South Africa
facility: Local Institution
state: Gauteng
city: Pretoria
country: South Africa
facility: Local Institution
state: Gauteng
city: Amanzimtoti
country: South Africa
facility: Local Institution
state: Kwa Zulu Natal
city: Bellville
country: South Africa
facility: Local Institution
state: Western Cape
city: Groenkloof
country: South Africa
facility: Local Institution
city: Torrevieja
country: Spain
facility: Local Institution
state: Alicante
city: Alcorcon(Madrid)
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Barcelona
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Madrid
country: Spain
facility: Local Institution
city: Sevilla
country: Spain
facility: Local Institution
city: Tarragona
country: Spain
facility: Local Institution
city: Goteborg
country: Sweden
facility: Local Institution
city: Lund
country: Sweden
facility: Local Institution
city: Yung-Kang City
country: Taiwan
facility: Local Institution
state: Tainan
city: Taichung
country: Taiwan
facility: Local Institution
city: Istanbul
country: Turkey
facility: Local Institution
state: Capa
city: Ankara
country: Turkey
facility: Local Institution
state: Dikimevi
city: Istanbul
country: Turkey
facility: Local Institution
city: Donetsk
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkiv
country: Ukraine
facility: Local Institution
city: Kharkov
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Kyiv
country: Ukraine
facility: Local Institution
city: Lutsk
country: Ukraine
facility: Local Institution
city: Lviv
country: Ukraine
facility: Local Institution
city: Uzhgorod
country: Ukraine
facility: Local Institution
city: Vinnitsa
country: Ukraine
facility: Local Institution
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: London
country: United Kingdom
facility: Local Institution
state: Greater London
city: Uxbridge
country: United Kingdom
facility: Local Institution
state: Middlesex
city: Newcastle
country: United Kingdom
facility: Local Institution
state: Tyne And Wear
city: Dudley
country: United Kingdom
facility: Local Institution
state: West Midlands
city: Hull
country: United Kingdom
facility: Local Institution
state: Yorkshire
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
citation: Chi G, Goldhaber SZ, Kittelson JM, Turpie AGG, Hernandez AF, Hull RD, Gold A, Curnutte JT, Cohen AT, Harrington RA, Gibson CM. Effect of extended-duration thromboprophylaxis on venous thromboembolism and major bleeding among acutely ill hospitalized medical patients: a bivariate analysis. J Thromb Haemost. 2017 Oct;15(10):1913-1922. doi: 10.1111/jth.13783. Epub 2017 Sep 4.
citation: Marszalek J, Mehrsefat S, Chi G. The risk of stroke among acutely ill hospitalized medical patients: lessons from recent trials on extended-duration thromboprophylaxis. Expert Rev Hematol. 2017 Aug;10(8):679-684. doi: 10.1080/17474086.2017.1343662. Epub 2017 Jun 21.
citation: Sharma A, Chatterjee S, Lichstein E, Mukherjee D. Extended thromboprophylaxis for medically ill patients with decreased mobility: does it improve outcomes? J Thromb Haemost. 2012 Oct;10(10):2053-60. doi: 10.1111/j.1538-7836.2012.04874.x.
citation: Goldhaber SZ, Leizorovicz A, Kakkar AK, Haas SK, Merli G, Knabb RM, Weitz JI; ADOPT Trial Investigators. Apixaban versus enoxaparin for thromboprophylaxis in medically ill patients. N Engl J Med. 2011 Dec 8;365(23):2167-77. doi: 10.1056/NEJMoa1110899. Epub 2011 Nov 13.