Efficacy and Safety Study of Apixaban for Extended Treatment of Deep Vein Thrombosis or Pulmonary Embolism

Venous Thrombosis Clinical Trial

Official title:

A Safety and Efficacy Trial Evaluating the Use of Apixaban for the Extended Treatment of Deep Vein Thrombosis and Pulmonary Embolism

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00633893
• Other study ID #: CV185-057
• Secondary ID: EUDRACT: 2007-00
• Status: Completed
• Phase: Phase 3
• First received: March 5, 2008
• Last updated: October 30, 2013
• Start date: May 2008
• Est. completion date: August 2012

Study information

• Verified date: October 2013
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug AdministrationCanada: Health CanadaArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyChile: Instituto de Salud Pública de ChileMexico: Federal Commission for Sanitary Risks ProtectionAustria: Federal Office for Safety in Health CareDenmark: Danish Medicines AgencyFrance: Ministry of HealthGermany: Ministry of HealthIsrael: Ministry of HealthItaly: Ministry of HealthNorway: Directorate of HealthSpain: Spanish Agency of MedicinesSouth Africa: Department of HealthTurkey: Ministry of HealthUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyCzech Republic: Ministry of HealthHungary: Ministry of Health, Social and Family AffairsPoland: Ministry of HealthRussia: Ministry of Health of the Russian FederationUkraine: Ministry of HealthAustralia: Department of Health and Ageing Therapeutic Goods AdministrationHong Kong: Department of HealthIndia: Central Drugs Standard Control OrganizationKorea: Food and Drug AdministrationMalaysia: National Pharmaceutical Control BureauTaiwan: Department of HealthRomania: National Medicines AgencyPortugal: National Pharmacy and Medicines Institute
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the effects of an investigational blood thinner, apixaban, in preventing venous thromboembolic (VTE) recurrence or death in patients who have completed their intended treatment for deep vein thrombosis (DVT) or pulmonary embolism (PE)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2711
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Men and women = 18 years of age;

• Clinical diagnosis of Deep Vein Thrombosis (DVT) or Pulmonary Embolism (PE);

• Anticoagulant treatment completed

• No recurrence of Venous Thromboembolism (VTE)

Exclusion Criteria:

• Subjects with indications for long-term treatment with a vitamin K antagonist

• Active bleeding or high risk for serious bleeding

• Short life expectancy

• Uncontrolled high blood pressure

• Impaired kidney or liver function

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pulmonary Embolism
• Thrombosis
• Venous Thrombosis

Intervention

Drug:
• Apixaban
Tablets, Oral, twice daily, 12 months
• Placebo
Tablets, Oral, twice daily, 12 months

Locations

Country	Name	City	State
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Capital Federal	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad De Buenos Aires	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Coronel Suarez	Buenos Aires
Argentina	Local Institution	Corrientes
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	La Plata	Buenos Aires
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	San Martin	Buenos Aires
Australia	Local Institution	Adelaide	South Australia
Australia	Local Institution	Bedford Park	South Australia
Australia	Local Institution	Box Hill	Victoria
Australia	Local Institution	Clayton	Victoria
Australia	Local Institution	Footscray	Victoria
Australia	Local Institution	Garran	Australian Capital Territory
Australia	Local Institution	Herston	Queensland
Australia	Local Institution	Kippa Ring	Queensland
Australia	Local Institution	Kogarah	New South Wales
Australia	Local Institution	Launceston	Tasmania
Australia	Local Institution	Lismore	New South Wales
Australia	Local Institution	Parkville	Victoria
Australia	Local Institution	Perth	Western Australia
Australia	Local Institution	Richmond	Victoria
Australia	Local Institution	Ringwood East	Victoria
Australia	Local Institution	St Leonards	New South Wales
Australia	Local Institution	Windsor	Victoria
Australia	Local Institution	Woolloongabba	Queensland
Austria	Local Institution	Graz
Austria	Local Institution	Innsbruck
Austria	Local Institution	Vienna
Austria	Local Institution	Vienna
Austria	Local Institution	Wien
Austria	Local Institution	Wien
Brazil	Local Institution	Belo Horizonte - Mg	Minas Gerais
Brazil	Local Institution	Belo Horizonte - Mg	Minas Gerais
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Brasilia	Distrito Federal
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Port Alegre	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Porto Alegre	Rio Grande Do Sul
Brazil	Local Institution	Rio De Janeiro
Brazil	Local Institution	Rio Janeiro	Rio De Janeiro
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Santo Andre - Sp	Sao Paulo
Brazil	Local Institution	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Local Institution	Sao Jose Do Rio Preto	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Brazil	Local Institution	Sao Paulo
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Edmonton	Alberta
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Kelowna	British Columbia
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Pointe- Claire	Quebec
Canada	Local Institution	Quebec
Canada	Local Institution	St. Jerome	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Victoria	British Columbia
Canada	Local Institution	Waterloo	Ontario
Canada	Local Institution	Windsor	Ontario
Chile	Local Institution	Independencia	Metropolitana
Chile	Local Institution	Punta Arenas	Magallanes Antartica
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Santiago	Metropolitana
Chile	Local Institution	Temuco	Araucania
Chile	Local Institution	Vina Del Mar	Valparaiso
Czech Republic	Local Institution	Kladno
Czech Republic	Local Institution	Litomysl
Czech Republic	Local Institution	Mestec Kralove
Czech Republic	Local Institution	Ostrava Vitkovice
Czech Republic	Local Institution	Plzen
Czech Republic	Local Institution	Praha 1
Czech Republic	Local Institution	Praha 1
Czech Republic	Local Institution	Praha 13
Czech Republic	Local Institution	Praha 2
Czech Republic	Local Institution	Praha 2
Czech Republic	Local Institution	Praha 2
Czech Republic	Local Institution	Praha 4
Czech Republic	Local Institution	Usti Nad Orlici
Denmark	Local Institution	Arhus C
Denmark	Local Institution	Braedstrup
Denmark	Local Institution	Esbjerg
Denmark	Local Institution	Frederiksberg
Denmark	Local Institution	Hellerup
Denmark	Local Institution	Herning
Denmark	Local Institution	Hilleroed
Denmark	Local Institution	Naestved
Denmark	Local Institution	Silkeborg
France	Local Institution	Arras
France	Local Institution	Besancon
France	Local Institution	Brest Cedex
France	Local Institution	Clamart
France	Local Institution	Clermont-Ferrand Cedex 01
France	Local Institution	Dijon
France	Local Institution	Grenoble
France	Local Institution	Le Kremlin-Bicetre
France	Local Institution	Lille Cedex
France	Local Institution	Limoges Cedex
France	Local Institution	Lyon Cedex 03
France	Local Institution	Nantes
France	Local Institution	Saint-Priest En Jarez
France	Local Institution	Toulouse Cedex 9
France	Local Institution	Vernon
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Bochum
Germany	Local Institution	Bonn
Germany	Local Institution	Cologne
Germany	Local Institution	Dortmund
Germany	Local Institution	Dresden
Germany	Local Institution	Dresden
Germany	Local Institution	Erfurt
Germany	Local Institution	Frankfurt
Germany	Local Institution	Gottingen
Germany	Local Institution	Karlsbad
Germany	Local Institution	Krefeld
Germany	Local Institution	Ludwigshafen
Germany	Local Institution	Mannheim
Germany	Local Institution	Mannheim
Germany	Local Institution	Mannheim
Germany	Local Institution	Munchen
Germany	Local Institution	Munich
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Shatin, N.T
India	Local Institution	Ahmedabad	Gujarat
India	Local Institution	Ahmedabad
India	Local Institution	Bangalore	Karnataka
India	Local Institution	Bangalore
India	Local Institution	Bangalore, Karnataka
India	Local Institution	Bengaluru	Karnataka
India	Local Institution	Chennai	Tamil Nadu
India	Local Institution	Chennai
India	Local Institution	Chennai
India	Local Institution	Gurgaon	Haryana
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Kochi	Kerala
India	Local Institution	Ludhiana	Tagore Nagar
India	Local Institution	Mohali	Punjab
India	Local Institution	New Dehli
India	Local Institution	Pune	Maharashtra
Israel	Local Institution	Afula
Israel	Local Institution	Givataim
Israel	Local Institution	Hadera
Israel	Local Institution	Haifa
Israel	Local Institution	Haifa
Israel	Local Institution	Holon
Israel	Local Institution	Jerusalem
Israel	Local Institution	Kfar Saba
Israel	Local Institution	Kiryat Hadassah
Israel	Local Institution	Nahariya
Israel	Local Institution	Petach-Tikva
Israel	Local Institution	Safed
Israel	Local Institution	Tel Aviv
Israel	Local Institution	Tel Hashomer
Italy	Local Institution	Bollate
Italy	Local Institution	Bologna
Italy	Local Institution	Chieti Scalo
Italy	Local Institution	Cosenza
Italy	Local Institution	Ferrara
Italy	Local Institution	Firenze
Italy	Local Institution	Genova
Italy	Local Institution	Milano
Italy	Local Institution	Padova
Italy	Local Institution	Palermo
Italy	Local Institution	Pavia
Italy	Local Institution	Perugia
Italy	Local Institution	Piacenza
Italy	Local Institution	Pisa
Italy	Local Institution	Roma
Italy	Local Institution	Rozzano (Mi)
Italy	Local Institution	San Daniele Del Friuli (Ud)
Italy	Local Institution	Udine
Italy	Local Institution	Venezia
Italy	Local Institution	Vicenza
Italy	Local Institution	Vittorio Veneto (Tv)
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Jongno-Gu
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Culiacan	Sinaloa
Mexico	Local Institution	Culiacan	Sinaloa
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Leon	Guanajuato
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Puebla
Mexico	Local Institution	Queretaro
Mexico	Local Institution	San Luis Potosi
Mexico	Local Institution	San Luis Potosi
Mexico	Local Institution	Tijuana	Baja California
Mexico	Local Institution	Xalapa	Veracruz
Mexico	Local Institution	Zapopan	Jalisco
Norway	Local Institution	Alesund
Norway	Local Institution	Fredrikstad
Norway	Local Institution	Gjettum
Norway	Local Institution	Gjovik
Norway	Local Institution	Hamar
Norway	Local Institution	Oslo
Philippines	Local Institution	Cavite
Philippines	Local Institution	Davao City
Philippines	Local Institution	Pasig City
Philippines	Local Institution	Quezon City
Poland	Local Institution	Arkonska 4
Poland	Local Institution	Bialystok
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Bydgoszcz
Poland	Local Institution	Gdansk
Poland	Local Institution	Gdynia
Poland	Local Institution	Gdynia
Poland	Local Institution	Lodz
Poland	Local Institution	Lublin
Poland	Local Institution	Lublin
Poland	Local Institution	Poznan
Poland	Local Institution	Przeworsk
Poland	Local Institution	Szczecin
Poland	Local Institution	Tarnobrzeg
Poland	Local Institution	Warsaw
Poland	Local Institution	Warsaw
Poland	Local Institution	Warsawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Wroclaw
Poland	Local Institution	Wroclaw
Portugal	Local Institution	Guarda
Portugal	Local Institution	Lisboa
Puerto Rico	Local Institution	San Juan
Puerto Rico	Local Institution	San Juan
Romania	Local Institution	Baia Mare
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Targu Mures
Russian Federation	Local Institution	Arkhangelsk
Russian Federation	Local Institution	Kemerovo
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Rostov-On Don
Russian Federation	Local Institution	Ryazan
Russian Federation	Local Institution	Saint Petersburg
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Saint-Petersburg
Russian Federation	Local Institution	Samara
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	St Petersburg
Russian Federation	Local Institution	Tomsk
Russian Federation	Local Institution	Yaroslavl
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
South Africa	Local Institution	Bellville	Western Cape
South Africa	Local Institution	Bloemfontein	Free State
South Africa	Local Institution	Centurion	Gauteng
South Africa	Local Institution	Durban	Kwa Zulu Natal
South Africa	Local Institution	George	Western Cape
South Africa	Local Institution	Parktown	Gauteng
South Africa	Local Institution	Pietermaritzburg	Kwa Zulu Natal
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Somerset West	Western Cape
South Africa	Local Institution	Worcester	Western Cape
Spain	Local Institution	Badalona	Barcelona
Spain	Local Institution	Cadiz
Spain	Local Institution	Getafe
Spain	Local Institution	Girona
Spain	Local Institution	L'Hospitalet De Llobregat
Spain	Local Institution	Leon
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Majadahonda	Madrid
Spain	Local Institution	Mourente
Spain	Local Institution	Pamplona
Spain	Local Institution	Salamanca
Spain	Local Institution	San Sebastian De Los Reyes	Madrid
Spain	Local Institution	Sant Boi De Llobregat
Spain	Local Institution	Tarragona
Spain	Local Institution	Toledo
Spain	Local Institution	Torrevieja	Alicante
Spain	Local Institution	Valencia
Ukraine	Local Institution	Chernihiv
Ukraine	Local Institution	Dnipropetrovsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Ivano-Frankivsk
Ukraine	Local Institution	Ivano-Frankivsk
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Lviv
Ukraine	Local Institution	Odesa
Ukraine	Local Institution	Ternopil
Ukraine	Local Institution	Vinnytsia
Ukraine	Local Institution	Zaporizhzhia
United Kingdom	Local Institution	Aberdeen	Aberdeenshire
United Kingdom	Local Institution	Bury St. Edmunds	Suffolk
United Kingdom	Local Institution	Coventry	West Midlands
United Kingdom	Local Institution	Dudley	West Midlands
United Kingdom	Local Institution	Hull	Humberside
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Manchester	Greater Manchester
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United Kingdom	Local Institution	Romford	Essex
United States	Akron General Medical Center	Akron	Ohio
United States	Amarillo Heart Clinical Research Institute Inc.	Amarillo	Texas
United States	Anne Arundel Health System Research Institute, Inc.	Annapolis	Maryland
United States	Rocky Mountain Internal Medicine	Aurora	Colorado
United States	Vascular Surgical Associates, Pc	Austell	Georgia
United States	Beaver Medical Group	Banning	California
United States	Bay Pines Va Healthcare Systems	Bay Pines	Florida
United States	Lake Washington Vascular, Pllc	Bellevue	Washington
United States	Alabama Clinical Therapeutics, Llc	Birmingham	Alabama
United States	Boise Orthopedic Clinic	Boise	Idaho
United States	Holston Medical Group	Bristol	Tennessee
United States	Kaleida Health System	Buffalo	New York
United States	Mercury Street Medical Group, Pllc	Butte	Montana
United States	Community Health Care, Inc.	Canal Fulton	Ohio
United States	Infectious Disease Of Indiana Psc	Carmel	Indiana
United States	Valley Medical Research	Centerville	Ohio
United States	Charleston Hematology Oncology Associates, Pa	Charleston	South Carolina
United States	University Of Virginia Health System	Charlottesville	Virginia
United States	Research Alliance, Inc.	Clearwater	Florida
United States	St. Francis Sleep Allergy & Lung Institute	Clearwater	Florida
United States	Ohio State University Medical Center	Columbus	Ohio
United States	Remington Davis Inc.	Columbus	Ohio
United States	Corsicana Medical Research	Corsicana	Texas
United States	Atlanta Institute For Medical Research, Inc	Decatur	Georgia
United States	Henry Ford Hospital	Detroit	Michigan
United States	Thomas L. Ortel, Md, Phd	Durham	North Carolina
United States	Valley Internal Medicine	Fayetteville	North Carolina
United States	Berma Research Group	Fort Lauderdale	Florida
United States	Fort Smith Lung Center	Fort Smith	Arkansas
United States	New West Physicians	Golden	Colorado
United States	Goshen Medical Associates	Goshen	New York
United States	Internal Medical Associates Of Grand Island, P.C	Grand Island	Nebraska
United States	Great Falls Clinic, Llp	Great Falls	Montana
United States	Greenville Hospital System	Greenville	South Carolina
United States	Kentucky Lung Clinic	Hazard	Kentucky
United States	Healthworx	Hollywood	Florida
United States	Ankur Doshi, Md	Houston	Texas
United States	Cape Cod Research Institute	Hyannis	Massachusetts
United States	Three Rivers Medical Associates, Pa	Irmo	South Carolina
United States	Veterans Affairs Medical Center	Kansas City	Missouri
United States	Holston Medical Group	Kingsport	Tennessee
United States	Scripps Clinic/Scripps Health And Green Hospital	La Jolla	California
United States	Gwinnett Biomedical Research	Lawrenceville	Georgia
United States	Tanner Clinic	Layton	Utah
United States	Sjh Cardiology Associates	Liverpool	New York
United States	Healthcare Partners Medical Group	Los Angeles	California
United States	Hematology Oncology Associates	Loxahatchee	Florida
United States	Medical Assoicates Inc.	Menomonee Falls	Wisconsin
United States	South Miami Heart Center	Miami	Florida
United States	Mission Internal Medical Group	Mission Viejo	California
United States	Clinical Research Authority, Llc	Murrells Inlet	South Carolina
United States	Saltzer Medical Group	Nampa	Idaho
United States	Physicians Regional Medical Group	Naples	Florida
United States	Office Of:Eugene C. Fletcher, Md	New Albany	Indiana
United States	Alfieri Cardiology	Newark	Delaware
United States	Sentara York Clinical Research	Norfolk	Virginia
United States	Cor Clinical Research, Llc	Oklahoma City	Oklahoma
United States	Creighton University Medical Center	Omaha	Nebraska
United States	Owensboro Heart & Vascular	Owensboro	Kentucky
United States	Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group	Palm Springs	California
United States	Cardiovascular Consultants, Ltd.	Phoenix	Arizona
United States	Pma Medical Specialists	Phoenixville	Pennsylvania
United States	Richard A. Mclean M.D., P.A.	Plantation	Florida
United States	Indus Clinical Research Institute, Inc.	Pomona	California
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Rex Healthcare	Raleigh	North Carolina
United States	Pen Bay Medical Center	Rockport	Maine
United States	William Beaumont Hospital	Royal Oak	Michigan
United States	University Of Utah Hospital	Salt Lake City	Utah
United States	Kaiser Permanente Medical Center	San Francisco	California
United States	Stanford University Medical Center	Stanford	California
United States	Richmond University Medical Center	Staten Island	New York
United States	Piedmont Healthcare/Research	Statesville	North Carolina
United States	Palmetto Clinical Research	Summerville	South Carolina
United States	Franciscan Research Center	Tacoma	Washington
United States	Tampa Clinical Research	Tampa	Florida
United States	Robert J. Bloomberg, Md, Pc	Tempe	Arizona
United States	Jobst Vascular Center At The Toledo Hospital	Toledo	Ohio
United States	Northwest Heart Center	Tomball	Texas
United States	Harbor Ucla Medical Center	Torrance	California
United States	New York Medical College	Valhalla	New York
United States	Primary Care Of The Treasure Coast, Inc.	Vero Beach	Florida
United States	Progressive Clinical Research	Vista	California
United States	Cleveland Clinic Florida	Weston	Florida
United States	Whiteville Medical Associates, P.A.	Whiteville	North Carolina
United States	Wilmington Medical Research	Wilmington	North Carolina
United States	Heartland Vascular Medicine And Surgery	Windsor Heights	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Brazil,  Canada,  Chile,  Czech Republic,  Denmark,  France,  Germany,  Hong Kong,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Norway,  Philippines,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	VTE included: nonfatal deep vein thrombosis (DVT) or nonfatal pulmonary embolism (PE). All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.	Day 1 up to 12 Months	No
Primary	Adjudicated Composite of Symptomatic, Recurrent Venous Thromboembolism (VTE) or All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE included: nonfatal DVT or nonfatal PE. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted. Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 months	No
Secondary	Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or VTE-related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate (proportion of participants with event) calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. For missing endpoint data, participants were imputed as having had a primary efficacy outcome event.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) -Related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE includes nonfatal DVT or nonfatal PE. All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Composite endpoint included events that occurred any time from randomization until end of the intended treatment period, regardless of whether the participants were receiving drug treatment. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. If there were missing endpoint data, participants were imputed as having had an efficacy outcome event.	Day 1 up to 12 Months	No
Secondary	Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population With Imputation	DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period: longer of the dosing period plus 2 days (completed treatment) or 355 days (discontinued early). Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months	No
Secondary	Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population With Imputation	PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months	No
Secondary	Adjudicated Venous Thromboembolism (VTE) - Related Death During the Intended Treatment Period - Randomized Population With Imputation	VTE-related death defined as: PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation).	Day 1 up to 12 Months	No
Secondary	Adjudicated Cardiovascular (CV)-Related Death During the Intended Treatment Period - Randomized Population With Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months	No
Secondary	Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population With Imputation	DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Participants with missing endpoint information were classified as having had the efficacy event (imputation). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 Months	No
Secondary	Number of Participants With an Adjudicated Symptomatic Nonfatal Venous Thromboembolism (VTE) Recurrence or Death (All Cause) During the Intended Treatment Period - Randomized Participants Without Imputation	All index events, DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. First event category was the first primary event for each participant and each participant was counted once. CV-related death was presented excluding VTE-related death. In participants with event category, each participant was counted once in each event category but could have been counted in multiple categories. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	No
Secondary	Adjudicated Major Bleeding During the Treatment Period - Treated Population	Major bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 grams per deciliter (g/dL) or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 milliliters (mL) or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ; or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated Composite of Major/Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	Major bleeding and clinically relevant non-major bleeding were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Major bleeding was defined as acute clinically overt bleeding: associated with a fall in hemoglobin of 2 g/dL or more, or leading to a transfusion of 2 or more units of packed red blood cells or 1000 mL or more of whole blood, or in a critical site: intracranial, intraspinal, intraocular, pericardial, intra-articular, intramuscular with compartment syndrome, retroperitoneal, or another critical organ or is fatal. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated Clinically Relevant Non-major Bleeding During the Treatment Period - Treated Participants	Non-major clinically relevant bleeding was adjudicated/confirmed by a central independent adjudication committee blinded to treatment and defined as: acute clinically overt bleeding compromising hemodynamics; leading to hospitalization; traumatic subcutaneous hematoma; intramuscular hematoma; epistaxis that lasted for more than 5 minutes, was repetitive or led to an intervention; spontaneous gingival bleeding (or lasting more than 5 minutes); spontaneous hematuria (macroscopic or lasted more than 24 hours after instrumentation of the urogenital tract); macroscopic gastrointestinal hemorrhage (including at least 1 episode of melena or hematemesis (if clinically apparent with positive results on a fecal occult-blood test); rectal blood loss. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits.	Day 1 up to 12 months	Yes
Secondary	Adjudicated Clinically Relevant Minor Bleeding During the Treatment Period - Treated Participants	All bleeding events were reviewed by the central independent adjudication committee blinded to treatment and classified as major bleeding, clinically relevant non-major bleeding, minor bleeding or no bleeding. If event was not major or clinically relevant non-major, it was judged to be minor. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Confidence interval (CI) for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 months	Yes
Secondary	Adjudicated Total Bleeding During the Treatment Period - Treated Participants	All bleeding events were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Total bleeding was defined as any major, clinically relevant non-major, or minor bleeding. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). CI for single event rate was calculated based on the Wald asymptotic confidence limits. Treated population includes randomized participants who received at least one dose of study drug.	Day 1 up to 12 months	Yes
Secondary	Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Venous Thromboembolism-related Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated Composite of Recurrent, Symptomatic Venous Thromboembolism (VTE) or Cardio Vascular (CV) - Related Death During the Intended Treatment Period - Randomized Population Without Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event. Index events of DVT and/or PE, along with myocardial infarction and stroke were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Composite endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for these endpoints; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	No
Secondary	Adjudicated Nonfatal Deep Vein Thrombosis (DVT) During the Intended Treatment Period - Randomized Population Without Imputation	DVT was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	No
Secondary	Adjudicated Nonfatal Pulmonary Embolism (PE) During the Intended Treatment Period - Randomized Population Without Imputation	PE was adjudicated/confirmed by a central independent adjudication committee blinded to treatment: PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	No
Secondary	Adjudicated Venous Thromboembolism (VTE)- Related Death During the Intended Treatment Period - Randomized Population Without Imputation	VTE related death defined as PE (based on objective diagnostic testing, autopsy), unexplained death (and VTE cannot be ruled out), sudden death (and VTE cannot be ruled out). DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, and death, were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated Cardio Vascular (CV)-Related Death During the Intended Treatment Period - Randomized Population Without Imputation	CV-related death was defined as myocardial infarction, stroke, or other specified cardiovascular event and these were adjudicated/confirmed by a central independent adjudication committee blinded to treatment. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	Yes
Secondary	Adjudicated All-Cause Death During the Intended Treatment Period - Randomized Population Without Imputation	DVT and/or PE were adjudicated/confirmed by a central independent adjudication committee blinded to treatment: DVT assessed by compression ultrasound and/or venography; PE assessed by spiral computed tomography scanning, pulmonary angiography, and/or ventilation/perfusion lung scan. New/recurrent VTE, death, venous/arterial thromboembolic events, bleeding, thrombocytopenia, acute myocardial infarction and stroke were also adjudicated. Event rate is proportion of participants with event; calculated as n/N (n=number of events; N=number of participants). Intended treatment period was defined as the longer of the dosing period plus 2 days or 355 days. Endpoint included events at any time from randomization until end of the intended treatment period, regardless whether drug treatment was received. No imputation was done for this endpoint; participants who had an event during the intended treatment period were counted.	Day 1 up to 12 Months	Yes

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