Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— ARISTOTLE  

Official title:

A Phase 3, Active (Warfarin) Controlled, Randomized, Double-Blind, Parallel Arm Study to Evaluate Efficacy and Safety of Apixaban in Preventing Stroke and Systemic Embolism in Subjects With Nonvalvular Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00412984
• Other study ID #: CV185-030
• Status: Completed
• Phase: Phase 3
• Start date: December 31, 2006
• Est. completion date: May 25, 2011

Study information

• Verified date: May 2018
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20976
• Est. completion date: May 25, 2011
• Est. primary completion date: May 25, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Males and females = 18 yrs with atrial fibrillation (AF) and one or more of the following risk factors for stroke:

• Age = 75, previous stroke

• transient ischemic attack (TIA) or Systemic Embolism (SE)

• Symptomatic congestive heart failure or left ventricular dysfunction with left ventricular ejection fraction (LVEF) = 40%

• Diabetes mellitus or hypertension requiring pharmacological treatment

Related Conditions & MeSH terms

• Atrial Fibrillation
• Atrial Flutter

Intervention

Drug:
• warfarin
Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
• apixaban
Oral tablets, 5.0 mg or 2.5 mg, twice daily

Locations

Country	Name	City	State
Argentina	Local Institution	Adrogue	Buenos Aires
Argentina	Local Institution	Bahia Blanca	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cipolletti	RIO Negro
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma De Buenos Aire	Buenos Aires
Argentina	Local Institution	Cordoba	Provincia DE Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Coronel Suarez	Buenos Aires
Argentina	Local Institution	Haedo	Buenos Aires
Argentina	Local Institution	Junin	Buenos Aires
Argentina	Local Institution	La Plata	Buenos Aires
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	Merlo	Buenos Aires
Argentina	Local Institution	Merlo	Buenos Aires
Argentina	Local Institution	Olivos	Buenos Aires
Argentina	Local Institution	Quilmes	Buenos Aires
Argentina	Local Institution	Ramos Mejia	Buenos Aires
Argentina	Local Institution	Ramos Mejia	Buenos Aires
Argentina	Local Institution	Ramos Mejia	Buenos Aires
Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Rosario	Santa Fe
Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Salta
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Philippines	Local Institution	Manila
Philippines	Local Institution	Naga City
Philippines	Local Institution	Pasig City
Philippines	Local Institution	Quezon
Philippines	Local Institution	Quezon City
Philippines	Local Institution	San Juan
Poland	Local Institution	Gdynia
Poland	Local Institution	Gdynia
Poland	Local Institution	Gdynia
Poland	Local Institution	Grodzisk Mazowiecki
Poland	Local Institution	Inowroclaw
Poland	Local Institution	Kielce
Poland	Local Institution	Kielce
Poland	Local Institution	Krakow
Poland	Local Institution	Krakow
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Lodz
Poland	Local Institution	Piotrkow Trybunalski
Poland	Local Institution	Plock
Poland	Local Institution	Plock
Poland	Local Institution	Plonsk
Poland	Local Institution	Poznan
Poland	Local Institution	Poznan
Poland	Local Institution	Ruda Slaska
Poland	Local Institution	Skierniewice
Poland	Local Institution	Slupsk
Poland	Local Institution	Torun
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Wegrow
Puerto Rico	Local Institution	Cayey
Puerto Rico	Local Institution	Cidra
Puerto Rico	Local Institution	Ponce
Romania	Local Institution	Baia Mare
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Bucharest
Romania	Local Institution	Cluj Napoca
Romania	Local Institution	Cluj Napoca
Romania	Local Institution	Iasi
Romania	Local Institution	Oradea
Romania	Local Institution	Sibiu
Romania	Local Institution	Targu-Mures
Romania	Local Institution	Timisoara
Romania	Local Institution	Timisoara
Romania	Local Institution	Tirgu Mures
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Chita
Russian Federation	Local Institution	Dzerzhinskiy
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Kemerovo
Russian Federation	Local Institution	Kirovsk
Russian Federation	Local Institution	Krasnodar
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Nizhni Novgorod
Russian Federation	Local Institution	Nizhni Novgorod
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Odintsovo
Russian Federation	Local Institution	Penza
Russian Federation	Local Institution	Perm
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	Saint-Petersburg
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	St Petersburg
Russian Federation	Local Institution	St Petersburg
Russian Federation	Local Institution	St-Petersburg
Russian Federation	Local Institution	St-Petersburg
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St. Petersburg
Russian Federation	Local Institution	St.-Petersburg
Russian Federation	Local Institution	St.Petersburg
Russian Federation	Local Institution	Tomsk
Russian Federation	Local Institution	Tumen
Russian Federation	Local Institution	Tver
Russian Federation	Local Institution	Voronezh
Russian Federation	Local Institution	Voronezh
Russian Federation	Local Institution	Yaroslavl
Russian Federation	Local Institution	Yaroslavl
Russian Federation	Local Institution	Yaroslavl
Russian Federation	Local Institution	Zheleznodorozhniy
Russian Federation	Local Institution	Zhukovsky
Russian Federation	Local Institution	Zhukovsky
Singapore	Local Institution	Singapore
South Africa	Local Institution	Bellville Cape Town	Western CAPE
South Africa	Local Institution	George	Western CAPE
South Africa	Local Institution	Observatory	Cape Town
South Africa	Local Institution	Parow	Western CAPE
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Pretoria	Gauteng
South Africa	Local Institution	Richards Bay	KWA ZULU Natal
South Africa	Local Institution	Somerset West	Western CAPE
South Africa	Local Institution	Westdene	Bloemfontein
South Africa	Local Institution	Worcester	Western CAPE
Spain	Local Institution	Albacete
Spain	Local Institution	Barcelona
Spain	Local Institution	Barcelona
Spain	Local Institution	Elda
Spain	Local Institution	Figueres
Spain	Local Institution	Gerona
Spain	Local Institution	La Canada	Almeria
Spain	Local Institution	Las Palmas
Spain	Local Institution	Lugo	Galicia
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Palma De Mallorca
Spain	Local Institution	San Juan	Alicante
Spain	Local Institution	San Sebastian De Los Reyes
Spain	Local Institution	Tarragona
Spain	Local Institution	Torrevieja	Alicante
Spain	Local Institution	Viladecans
Sweden	Local Institution	Goteberg
Sweden	Local Institution	Helsingborg
Sweden	Local Institution	Linkoping
Sweden	Local Institution	Lund
Sweden	Local Institution	Orebro
Sweden	Local Institution	Orebro
Sweden	Local Institution	Skelleftea
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Sweden	Local Institution	Vaxjo
Switzerland	Local Institution	Baden
Switzerland	Local Institution	Bern
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Turkey	Local Institution	Ankara
Turkey	Local Institution	Eskisehir
Turkey	Local Institution	Izmir
Ukraine	Local Institution	Chernivtsy
Ukraine	Local Institution	Dnipropetrovsk
Ukraine	Local Institution	Dnipropetrovsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Ivano-Frankivsk
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkov
Ukraine	Local Institution	Kharkov
Ukraine	Local Institution	Kharkov
Ukraine	Local Institution	Kiev
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Lugansk
Ukraine	Local Institution	Lugansk
Ukraine	Local Institution	Lutsk
Ukraine	Local Institution	Lviv
Ukraine	Local Institution	Lviv
Ukraine	Local Institution	Mykolayiv
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Odessa
Ukraine	Local Institution	Uzhgorod
Ukraine	Local Institution	Vinnitsa
Ukraine	Local Institution	Zaporozhye
Ukraine	Local Institution	Zhytomyr
United Kingdom	Local Institution	Aberdeen	Aberdeenshire
United Kingdom	Local Institution	Antrim
United Kingdom	Local Institution	Barnet	Hertfordshire
United Kingdom	Local Institution	Barnsley	South Yorkshire
United Kingdom	Local Institution	Belfast	Antrim
United Kingdom	Local Institution	Birmingham	WEST Midlands
United Kingdom	Local Institution	Blackpool
United Kingdom	Local Institution	Bournemouth	Dorset
United Kingdom	Local Institution	Bury St Edmunds	Suffolk
United Kingdom	Local Institution	Bury St Edmunds	Suffolk
United Kingdom	Local Institution	Bury St. Edmunds	Suffolk
United Kingdom	Local Institution	Cambridge	Cambridgeshire
United Kingdom	Local Institution	Cardiff	MID Glamorgan
United Kingdom	Local Institution	Chesterfield	Derbyshire
United Kingdom	Local Institution	Chesterfield	Derbyshire
United Kingdom	Local Institution	Chichester	EAST Sussex
United Kingdom	Local Institution	Colchester	Essex
United Kingdom	Local Institution	Craigavon	Armagh
United Kingdom	Local Institution	Denmark Hill	Greater London
United Kingdom	Local Institution	Doncaster	South Yorkshire
United Kingdom	Local Institution	Glasgow
United Kingdom	Local Institution	Glasgow	Strathclyde
United Kingdom	Local Institution	Glasgow	Dumbartonshire
United Kingdom	Local Institution	Glasgow	Aberdeenshire
United Kingdom	Local Institution	Harrow	Middlesex
United Kingdom	Local Institution	Ipswich	Suffolk
United Kingdom	Local Institution	Ipswich	Suffolk
United Kingdom	Local Institution	Livingston	WEST Lothian
United Kingdom	Local Institution	Llandough	MID Glamorgan
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Newcastle Upon Tyne	Tyne and Wear
United Kingdom	Local Institution	Newport	Gwent
United Kingdom	Local Institution	Nottingham	Nottinghamshire
United Kingdom	Local Institution	Paisley	Renfrewshire
United Kingdom	Local Institution	Peterborough	Cambridgeshire
United Kingdom	Local Institution	Romford	Essex
United Kingdom	Local Institution	Stirling	Stirlingshire
United Kingdom	Local Institution	Swansea	WEST Glamorgan
United Kingdom	Local Institution	Westbury	Wiltshire
United Kingdom	Local Institution	Westbury	Wiltshire
United Kingdom	Local Institution	Worksop	Nottinghamshire
United Kingdom	Local Institution	York	Yorkshire
United Kingdom	Local Institution	York	Yorkshire
United States	Abington Medical Specialists	Abington	Pennsylvania
United States	Akron Cardiology Consultants	Akron	Ohio
United States	Albany Assoc. In Cardiology	Albany	New York
United States	Albany Associates In Cardiology	Albany	New York
United States	Abq Health Partners, Llc	Albuquerque	New Mexico
United States	University Of New Mexico/University Hospital	Albuquerque	New Mexico
United States	University Of New Mexico/University Hospital	Albuquerque	New Mexico
United States	Alexandria Cardiology Clinic	Alexandria	Louisiana
United States	Great Lakes Heart Center Of Alpena	Alpena	Michigan
United States	Blair Medical Associates, Inc.	Altoona	Pennsylvania
United States	Amarillo Heart Clinical Research Institute Inc.	Amarillo	Texas
United States	Mcfarland Clinic Pc	Ames	Iowa
United States	Advanced Clinical Reserach Institute	Anaheim	California
United States	Alaska Heart Institute	Anchorage	Alaska
United States	Community Clinical Research Center	Anderson	Indiana
United States	Southeastern Research Associates, Inc	Anderson	South Carolina
United States	Asheville Cardiology Associates	Asheville	North Carolina
United States	Cardiovascular Specialits, Pc	Atlanta	Georgia
United States	Medical Specialist Of The Palm Beach	Atlantis	Florida
United States	Augusta Cardiology Clinic, P.C.	Augusta	Georgia
United States	Fox Valley Clinical Research Center, Llc	Aurora	Illinois
United States	Miami International Cardiology Consultants	Aventura	Florida
United States	Franklin Square Hospital	Baltimore	Maryland
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland
United States	Midatlantic Cardiovascular Associates, P.A.	Baltimore	Maryland
United States	Midatlantic Cardiovascular Associates, P.A.	Baltimore	Maryland
United States	Midatlantic Cardiovascular Associates, P.A.	Baltimore	Maryland
United States	Midatlantic Cardiovascular Associates, Pa	Baltimore	Maryland
United States	Midatlantic Cardiovascular Associates, Pa	Baltimore	Maryland
United States	Lowcountry Medical Group	Beaufort	South Carolina
United States	Lowcountry Medical Group, Llc	Beaufort	South Carolina
United States	Midatlantic Cardiovascular Associates, Pa	Bel Air	Maryland
United States	St. Charles Health System, Inc	Bend	Oregon
United States	St. Charles Health System, Inc.	Bend	Oregon
United States	Comprehensive Clinical Research	Berlin	New Jersey
United States	Act/Cardiovascular Research Institute	Beverly Hills	California
United States	Burlington Medical Associates	Billerica	Massachusetts
United States	Cardiology Associates, Pc	Binghamton	New York
United States	Alabama Internal Medicine Pc	Birmingham	Alabama
United States	Birmingham Heart Clinic P.C.	Birmingham	Alabama
United States	Cardiovascular Associates, Pc	Birmingham	Alabama
United States	Premier Healthcare, Llc	Bloomington	Indiana
United States	David Charles Mishkel, Md, Pa	Boca Raton	Florida
United States	Caritas St. Elizabeth'S Medical Center	Boston	Massachusetts
United States	Bridgeport Hospital	Bridgeport	Connecticut
United States	Connecticut Clinical Research, Llc	Bridgeport	Connecticut
United States	Holston Medical Group	Bristol	Tennessee
United States	Christopher M. Johnson, D.O.	Bucyrus	Ohio
United States	Christopher M. Johnson, D.O.	Bucyrus	Ohio
United States	Bruce L. Platt Md, Pc	Buffalo	New York
United States	Bruce L. Platt, Md	Buffalo	New York
United States	Buffalo Heart Group, Llp	Buffalo	New York
United States	Buffalo Heart Group, Llp	Buffalo	New York
United States	Daniel W. Gottlieb, Md, Ps	Burien	Washington
United States	Daniel William Gottlieb, Md	Burien	Washington
United States	Kernodle Clinic, Inc.	Burlington	North Carolina
United States	Lahey Clinic Medical Center	Burlington	Massachusetts
United States	Heritage Cardiology Assoc.	Camp Hill	Pennsylvania
United States	Community Health Care, Inc.	Canal Fulton	Ohio
United States	Cardiology Associates	Canton	Ohio
United States	Capitol Interventional Cardiology	Carmichael	California
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Nmff	Chicago	Illinois
United States	The Carl & Edyth Lindner Center For R&E At The Christ Hosp	Cincinnati	Ohio
United States	The Heart & Vascular Institute Of Florida	Clearwater	Florida
United States	The Heart And Vascular Institute Of Florida	Clearwater	Florida
United States	Electrophysiology Associates, Pc	Colorado Springs	Colorado
United States	Cardiovascular Specialists Of Central Maryland, P.A.	Columbia	Maryland
United States	Columbia Heart Clinic	Columbia	South Carolina
United States	University Of Missouri	Columbia	Missouri
United States	Columbus Cardiology Associates Pc	Columbus	Georgia
United States	Columbus Cardiology Associates,Pc	Columbus	Georgia
United States	Corsicana Medical Research, Pllc	Corsicana	Texas
United States	Georgia Heart Specialists, L.L.C.	Covington	Georgia
United States	Heartplace	Dallas	Texas
United States	Soltero Cardiovascular Research Center	Dallas	Texas
United States	Cardiovascular Specialist Of South Florida	Davie	Florida
United States	Daytona Heart Group	Daytona Beach	Florida
United States	Atlanta Institute For Medical Research, Inc	Decatur	Georgia
United States	Aurora Denver Cardiology Associates, P.C.	Denver	Colorado
United States	Denver Va Medical Center	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Central Bucks Cardiology	Doylestown	Pennsylvania
United States	Heart Care Center, P.C.	East Syracuse	New York
United States	Central Cardiology Assoc.	Elizabethtown	Kentucky
United States	Elkhart Clinic, Llc	Elkhart	Indiana
United States	Cardiovascular Associates Of The Delware Valley, P.A.	Elmer	New Jersey
United States	Internal Medicine And Lipid Mgmt.	Erie	Pennsylvania
United States	Escondido Cardiology Associates, Inc.	Escondido	California
United States	Oregon Medical Group - Clinical Research	Eugene	Oregon
United States	Neccr Internal Medicine & Cardiology Associates,Llc	Fall River	Massachusetts
United States	Lillestol Research Llc	Fargo	North Dakota
United States	Broward General Medical Center	Fort Lauderdale	Florida
United States	Cardiology Associates Of Fort Lauderdale, P.A.	Fort Lauderdale	Florida
United States	Florida Heart Associates	Fort Myers	Florida
United States	Fort Wayne Cardiology	Fort Wayne	Indiana
United States	Lutheran Medical Group, Llc	Fort Wayne	Indiana
United States	Heart Center Of North Texas	Fort Worth	Texas
United States	Florida Research Network, Llc	Gainesville	Florida
United States	Northeast Georgia Heart Center, Pc	Gainesville	Georgia
United States	New West Physicians Clinical Research	Golden	Colorado
United States	Internal Medical Associates of Grand Island, P.C	Grand Island	Nebraska
United States	Internal Medical Associates Of Grand Island, P.C	Grand Island	Nebraska
United States	Cardiology Associates Of Green Bay Ltd-Bellin Hospital	Green Bay	Wisconsin
United States	Upstate Cardiology	Greenville	South Carolina
United States	Internal Medicine Of Greer	Greer	South Carolina
United States	Cardiology Associates Of New Haven,Pc	Guilford	Connecticut
United States	Clinical Investigation Specialists, Inc	Gurnee	Illinois
United States	Cardiovascular Associates Of The Delaware Valley, P.A.	Haddon Heights	New Jersey
United States	Kandra, Fierer, Kuskin Associates	Harrisburg	Pennsylvania
United States	Nebraska Heart Institute	Hastings	Nebraska
United States	Pivotal Clinical Research, Llc	Hatfield	Pennsylvania
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	William D. Bowden, D.O.	Healdsburg	California
United States	Carolina Cardiology Associates, Pa	High Point	North Carolina
United States	Hillsboro Cardiology Pc	Hillsboro	Oregon
United States	Healthworx	Hollywood	Florida
United States	Luis Tami, Md	Hollywood	Florida
United States	Dr. Rajesh Shroff	Hot Springs	Arkansas
United States	Cardiovascular Institute Of The South	Houma	Louisiana
United States	Center For Atrial Fibrillation	Houston	Texas
United States	Francisco R. Maislos	Houston	Texas
United States	Northwest Houston Cardiology, Pa	Houston	Texas
United States	Northwest Houston Cardiology, Pa	Houston	Texas
United States	The Methodist Hospital	Houston	Texas
United States	The Methodist Hospital Neurology Institute	Houston	Texas
United States	The University Of Texas Md Anderson Cancer Center	Houston	Texas
United States	Woodlands North Houston Heart Center	Houston	Texas
United States	Regional Medical Center And Diagnostic Clinics	Humble	Texas
United States	Huntington Hospital	Huntington	New York
United States	Heart Center, Inc.	Huntsville	Alabama
United States	St Francis Medical Group - Indiana Heart Physicians	Indianapolis	Indiana
United States	The Care Group, Llc	Indianapolis	Indiana
United States	The Care Group, Llc.	Indianapolis	Indiana
United States	Nature Coast Clinical Research	Inverness	Florida
United States	Jacksonville Cardiovascular Center	Jacksonville	Florida
United States	Jacksonville Center For Clinical Research	Jacksonville	Florida
United States	Jacksonville Heart Center, Pa	Jacksonville	Florida
United States	Jacksonville Heart Center, Pa	Jacksonville	Florida
United States	St. Luke'S Cardiology	Jacksonville	Florida
United States	St. Vincent'S Ambulatory Care, Inc	Jacksonville	Florida
United States	Jacksonville Heart Center, P.A.	Jacksonville Beach	Florida
United States	Lycoming Internal Medicine Inc.	Jersey Shore	Pennsylvania
United States	Cvms Research Institute, Llc	Jupiter	Florida
United States	Ricardo Bedoya, M.D.	Jupiter	Florida
United States	Saint Luke'S Lipid And Diabetes Research Center	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri
United States	Holston Medical Group	Kingsport	Tennessee
United States	Knoxville Heart Group	Knoxville	Tennessee
United States	Volunteer Research Group	Knoxville	Tennessee
United States	Volunteer Research Group	Knoxville	Tennessee
United States	La Mesa Cardiac Center, A Medical Group	La Mesa	California
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Wilford Hall Medical Center	Lackland Air Force Base	Texas
United States	Smith, Patel & Amkieh, Llc	Lacombe	Louisiana
United States	Imperial Calcasieu Medical Group, Llp	Lake Charles	Louisiana
United States	Thoracic And Cardiovascular Healthcare Foundation	Lansing	Michigan
United States	Va Southern Nevada Healthcare System	Las Vegas	Nevada
United States	Utah Cardiology P.C	Layton	Utah
United States	Lynn N. Smith, Md	Lewisburg	West Virginia
United States	Central Maine Heart & Vascular Institute	Lewiston	Maine
United States	New Lexington Clinic, P.S.C.	Lexington	Kentucky
United States	Mary K. Richards, Md Pa	Little Rock	Arkansas
United States	South Denver Cardiology Associates Pc	Littleton	Colorado
United States	Sjh Cardiology Associates	Liverpool	New York
United States	Advanced Cardiovascular Health Specialists, Pc	Livonia	Michigan
United States	Dcol Center For Clinical Research	Longview	Texas
United States	Va Greater Los Angeles Healthcare System	Los Angeles	California
United States	Norton Cardiovascular Associates	Louisville	Kentucky
* Note: There are 1113 locations in all - only the first 1000 are shown.

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Hong Kong,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Puerto Rico,  Romania,  Russian Federation,  Singapore,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Adverse Events (AEs), Bleeding AEs, Serious Adverse Events (SAEs), Discontinuations Due to AEs, or Deaths During the Treatment Period	AE: all SAEs or AEs with onset from first dose through 2 days (AEs) or 30 days (SAEs) after the last dose of blinded study drug (BSD). SAE: all SAEs with onset from first dose through 30 days after the last dose of BSD. Bleeding AE: all serious or non-serious bleeding-related AEs with onset from first dose through 2 days after the last dose of BSD. Discontinuations due to AE: all SAEs or AEs with onset from first dose of BSD and with action taken=drug discontinued. Deaths: all deaths occurring from first dose through 30 days after the last dose of BSD.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Other	Rate of Adjudicated Bleeding Endpoints Per Global Use of Strategies to Open Occluded Coronary Arteries (GUSTO) During the Treatment Period	Rate=number of adjudicated GUSTO bleeding events per 100 patient years. GUSTO Bleeding Criteria: GUSTO severe (or life-threatening) bleeding: either intracranial hemorrhage or bleeding that causes hemodynamic compromise and requires intervention. GUSTO moderate bleeding: bleeding that requires blood transfusion but does not result in hemodynamic compromise.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Other	Rate of Adjudicated Bleeding Endpoints Per Thrombolysis in Myocardial Infarction (TIMI) During the Treatment Period	Rate=number of adjudicated TIMI bleeding events per 100 patient years. TIMI Bleeding Criteria: Major bleeding=Intracranial bleeding and/or clinically overt bleeding associated with =5 gm/dL fall in Hgb or 15% fall in hematocrit (Hct) from baseline, accounting for transfusions. Minor bleeding=Clinically overt bleeding associated with =3 gm/dL fall in Hgb or a =10% fall in Hct from baseline, accounting for transfusions.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Other	Number of Participants With Net-Clinical Benefit During Treatment Period	Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Other	Rate of Net-Clinical Benefit During Treatment Period	Rate=number of events of net-clinical benefit per 100 patient years. Net-Clinical Benefit = Composite of stroke, systemic embolism and ISTH major bleeding	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Primary	Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period	All suspected efficacy events were adjudicated by the Central Events Committee (CEC). Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.	Time to first event in "Intended Treatment Period": started on day of randomization, ended at efficacy cut-off date (date target number of primary efficacy events [448] was expected to have occurred; set to 30-Jan-2011, prior to unblinding).
Primary	Rate of Adjudicated Stroke or Systemic Embolism (SE) During the Intended Treatment Period	Rate=Number of adjudicated stroke or SE events per 100 patient years. Diagnosis of stroke=the nontraumatic focal neurological deficit lasting at least 24 hours, and includes ischemic stroke, hemorrhagic stroke, ischemic stroke with hemorrhagic conversion, stroke of uncertain type, and retinal ischemic event (embolism, infarction). Diagnosis of SE=clinical history consistent with an acute loss of blood flow to a peripheral artery (or arteries), supported by evidence of embolism from surgical specimens, autopsy, angiography, vascular imaging, or other objective testing.	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Number of Participants With Event of Major (International Society on Thrombosis and Hemostasis [ISTH]) Bleeding During Treatment Period	ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more, and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following critical sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary	Rate of Adjudicated Major (ISTH) Bleed Events During Treatment Period	Rate=number of adjudicated major (ISTH) bleed events per 100 patient years. ISTH Bleeding Criteria: Major bleeding=a bleeding event that was: clinically overt bleeding accompanied by a decrease in hemoglobin (Hgb) of 2 g/dL or more and/or a transfusion of 2 or more units of packed red blood cells; bleeding that occurred in at least 1 of the following sites: intracranial, intraspinal, intraocular (within the corpus of the eye; a conjunctival bleed is not an intraocular bleed), pericardial, intra-articular, intramuscular with compartment syndrome, and retroperitoneal; bleeding that was fatal.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary	Number of Participants With Events of All-Cause Death During the Intended Treatment Period	Death was defined as all-cause mortality. All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, myocardial infarction (MI), sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Rate of Adjudicated All-Cause Death During the Intended Treatment Period	All unobserved deaths were assumed to be cardiovascular in nature unless a non-cardiovascular cause could be clearly provided. Cardiovascular=deaths due to ischemic and hemorrhagic stroke, SE, MI, sudden death, heart failure, other cardiovascular, and unobserved deaths. Non-cardiovascular=all deaths due to a clearly documented non-cardiovascular cause (further classified into the categories: bleeding, study drug toxicity other than bleeding, malignancy, infection, trauma, and pulmonary causes of death).	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), and Myocardial Infarction (MI) (as Individual Endpoints) During the Intended Treatment Period	Diagnosis for an acute or evolving MI=elevation of creatine kinase-MB isoenzyme (CK-MB) or Troponin T or I = 2 × the upper limit of normal (ULN), or if no CK-MB or troponin values are available, a total CK = 2×ULN, or new, significant (=0.04 s) Q waves in =2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1.	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Rate of Ischemic or Unspecified Stroke, Hemorrhagic Stroke, Systemic Embolism (SE), Myocardial Infarction (MI) and All-Cause Death (ACD) (as Composite Endpoints) During the Intended Treatment Period	Diagnosis for an acute or evolving MI=elevation of CK-MB or Troponin T or I = 2 × the ULN, or if no CK-MB or troponin values are available, a total CK = 2×ULN, or new, significant (=0.04 s) Q waves in =2 contiguous leads. For descriptions of Stroke and SE, see Outcome Measure 1. For description of ACD, see Outcome Measure 5.	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Number of Warfarin/Vitamin K Antagonist (VKA) Naive Participants With Composite Stroke / Systemic Embolism (SE) / Major Bleeding During the Intended Treatment Period	For descriptions of Stroke and SE, see Outcome Measure 1. For description of Major bleeding, see Outcome Measure 3.	"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Rate of Composite Stroke / Systemic Embolism / Major Bleeding in Warfarin/Vitamin K Antagonist (VKA) Naive Participants During the Intended Treatment Period		"Intended Treatment Period" started on the day of randomization and ended at the efficacy cut-off date (date on which it was expected that the target number of primary efficacy events [448] would have occurred; set to 30-Jan-2011, prior to unblinding).
Secondary	Number of Participants With Events of Major or Clinically Relevant Nonmajor (CRNM) Bleed During Treatment Period	Major bleeding=bleeding that is clinically overt and that either resulted in a decrease in hemoglobin of 2 g/dL or more over a 24-hour period, led to a transfusion of 2 or more units of packed red blood cells, occurred in a critical site, or led to death. CRNM bleeding=bleeding that is clinically overt, that satisfies none of the additional criteria required for the event to be adjudicated as a major bleeding event, that led to either hospital admission for bleeding, physician-guided medical or surgical treatment for bleeding, or a change in antithrombotic therapy.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary	Rate of Events of Major or Clinically Relevant Non-Major (CRNM) Bleed During Treatment Period	Rate=number of major or CRNM bleed events per 100 patient years. Major=clinically overt and either 1) resulted in a decrease in hemoglobin of 2 g/dL or more, or 2) led to a transfusion of 2 or more units of packed red blood cells, or 3) occurred in a critical site, or 4) led to death. CRNM bleeding=clinically overt, but satisfied no additional criteria required to be adjudicated as a major bleeding event, and led to either 1) hospital admission for bleeding or 2) physician guided medical or surgical treatment for bleeding or 3) a change in antithrombotic therapy.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary	Number of Participants With All Bleeding Events During Treatment Period	All bleeding events include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.
Secondary	Rate of All Bleeding Events During Treatment Period	Rate=number of all bleeding events per 100 patient years. "All bleeding events" include major bleeding, CRNM bleeding (see Outcome Measure 12 Description for definitions), plus events of minor bleeding and fatal bleeding. Minor bleeding: All acute clinically overt bleeding events not meeting the criteria for either major bleeding or clinically relevant non-major bleeding will be classified as minor bleeding. Fatal bleeding is defined as a bleeding event that the Clinical Events Committee determines is the primary cause of death or contributes directly to death.	"Treatment Period" started with first dose of blinded study drug and ended 2 days after the last dose of blinded study drug. Mean duration of exposure to double-blind study drug was 1.7 years in each treatment group.

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