A Phase III Study of Apixaban in Patients With Atrial Fibrillation

Atrial Fibrillation Clinical Trial

— AVERROES  

Official title:

Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00496769
• Other study ID #: CV185-048
• Status: Completed
• Phase: Phase 3
• Start date: August 31, 2007
• Est. completion date: May 25, 2017

Study information

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

Clinical Trial Summary

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.

Description:

An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

Recruitment information / eligibility

• Status: Completed
• Enrollment: 6421
• Est. completion date: May 25, 2017
• Est. primary completion date: November 30, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Key Inclusion Criteria:

• Male and female

• Age of 50 years or older

• Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)

• At least 1 of the following risk factors for stroke:

• Prior stroke or transient ischemic attack

• Age of 75 years or older

• Arterial hypertension on treatment

• Diabetes mellitus

• Heart failure (New York Health Authority Class 2 or greater at time of enrollment)

• Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment

• Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)

• Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

• Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued

• Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

• Women who are pregnant or breast feeding

• Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy

• Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis

• Valvular disease requiring surgery

• Planned ablation procedure for atrial fibrillation to be performed within 3 months

• Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)

• Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

• Active peptic ulcer disease

• Platelet count <100,000/mm^3 or hemoglobin <10g/dL

• Recent stroke (within 10 days)

• Documented hemorrhagic tendencies or blood dyscrasias

• Current alcohol or drug abuse or psychosocial reasons that make study participation impractical

• Severe comorbid condition with life expectancy <1 year

• Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded

• Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)

• Allergy or adverse reaction to acetylsalicylic acid

• Required treatment with a thienopyridine (clopidogrel or ticlopidine)

• Prisoners or participants who are compulsory detained (involuntarily incarcerated)

• Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study

• Patients who are compulsorily detained for treatment for a psychiatric or physical illness

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Drug:
• Apixaban
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
• Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Locations

Country	Name	City	State
Argentina	Local Institution	Adrogue	Buenos Aires
Argentina	Local Institution	Autonoma Buenos Aires	Buenos Aires
Argentina	Local Institution	Bahia Blanca	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Cordoba
Argentina	Local Institution	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	Corrientes
Argentina	Local Institution	Haedo	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	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	Salta
Argentina	Local Institution	San Francisco	Cordoba
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Argentina	Local Institution	San Miguel De Tucuman	Tucuman
Argentina	Local Institution	San Salvador De Jujuy	Jujuy
Argentina	Local Institution	Santa Fe
Argentina	Local Institution	Zarate	Provincia Buenos Aires
Australia	Local Institution	Auchenflower	Queensland
Australia	Local Institution	Coffs Harbour	New South Wales
Australia	Local Institution	Concord	New South Wales
Australia	Local Institution	Geelong	Victoria
Australia	Local Institution	Gosford	New South Wales
Australia	Local Institution	Joondalup	Western Australia
Australia	Local Institution	Kingswood	New South Wales
Australia	Local Institution	Kippa Ring	Queensland
Australia	Local Institution	Milton	Queensland
Australia	Local Institution	Woolloongabba	Queensland
Austria	Local Institution	Graz
Austria	Local Institution	Linz
Austria	Local Institution	Oberpullendorf
Austria	Local Institution	Salzburg
Belgium	Local Institution	Aalst
Belgium	Local Institution	Brasschaat
Belgium	Local Institution	Brussel
Belgium	Local Institution	Bruxelles
Belgium	Local Institution	De Pinte
Belgium	Local Institution	Genk
Belgium	Local Institution	Huy
Belgium	Local Institution	Roeselare
Belgium	Local Institution	Turnhout
Brazil	Local Institution	Belem	Para
Brazil	Local Institution	Belo Horizonte	Minas Gerais
Brazil	Local Institution	Blumenau	Santa Catarina
Brazil	Local Institution	Botucatu	Sao Paulo
Brazil	Local Institution	Campina Grande Do Sul	Parana
Brazil	Local Institution	Campinas	Sao Paulo
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Curitiba	Parana
Brazil	Local Institution	Marilia	Sao Paulo
Brazil	Local Institution	Marilia	Sao Paulo
Brazil	Local Institution	Maringa	Parana
Brazil	Local Institution	Natal	Rio Grande Do Norte
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	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	Salvador	Bahia
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	San Jose- Do Rio Preto	Sao Paulo
Brazil	Local Institution	Sao Jose	Santa Catarina
Brazil	Local Institution	Sao Jose Do Rio Preto	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
Brazil	Local Institution	Uberaba	Minas Gerais
Brazil	Local Institution	Uberaba	Minas Gerais
Canada	Local Institution	Brampton	Ontario
Canada	Local Institution	Burlington	Ontario
Canada	Local Institution	Cambridge	Ontario
Canada	Local Institution	Cambridge	Ontario
Canada	Local Institution	Greenfield Park	Quebec
Canada	Local Institution	Grimsby	Ontario
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Hamilton	Ontario
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	Montreal	Quebec
Canada	Local Institution	New Westminster	British Columbia
Canada	Local Institution	Oshawa	Ontario
Canada	Local Institution	Oshawa,	Ontario
Canada	Local Institution	Ottawa	Ontario
Canada	Local Institution	Quebec
Canada	Local Institution	Saint Georges Beauce	Quebec
Canada	Local Institution	Sarnia	Ontario
Canada	Local Institution	Saskatoon	Saskatchewan
Canada	Local Institution	St. Jerome	Quebec
Canada	Local Institution	St. Lambert	Quebec
Canada	Local Institution	Sudbury	Ontario
Canada	Local Institution	Sudbury	Ontario
Canada	Local Institution	Terrebonne	Quebec
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Toronto	Ontario
Canada	Local Institution	Westmount	Quebec
Canada	Local Institution	Weston	Ontario
Canada	Local Institution	Winnipeg	Manitoba
Chile	Local Institution	Osorno	LOS Lagos
Chile	Local Institution	Santiago	Metropolitana
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	Valdivia	Los Rios
Chile	Local Institution	Victoria	Araucania
Chile	Local Institution	Vina Del Mar	Valparaiso
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Beijing	Beijing
China	Local Institution	Chengdu	Sichuan
China	Local Institution	Dalian	Liaoning
China	Local Institution	Guangzhou	Guangdong
China	Local Institution	Qingdao	Shandong
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shanghai	Shanghai
China	Local Institution	Shenyang	Liaoning
China	Local Institution	Shijiazhuang	Hebei
China	Local Institution	Suzhou	Jiangsu
China	Local Institution	Wuhan	Hubei
Colombia	Local Institution	Barranquilla	Atlantico
Colombia	Local Institution	Bogota
Colombia	Local Institution	Bucaramanga	Santander
Colombia	Local Institution	Cali	Valle DEL Cauca
Colombia	Local Institution	Medellin	Antioquia
Czechia	Local Institution	Brno
Czechia	Local Institution	Havirov - Mesto
Czechia	Local Institution	Jindrichuv Hradec
Czechia	Local Institution	Kladno
Czechia	Local Institution	Kromeriz
Czechia	Local Institution	Mestec Kralove
Czechia	Local Institution	Ostrava
Czechia	Local Institution	Pisek
Czechia	Local Institution	Praha 1
Czechia	Local Institution	Praha 2
Czechia	Local Institution	Praha 5
Czechia	Local Institution	Prelouc
Czechia	Local Institution	Pribram
Czechia	Local Institution	Slany
Czechia	Local Institution	Usti Nad Orlici
Denmark	Local Institution	Arhus C
Denmark	Local Institution	Esbjerg
Denmark	Local Institution	Frederiksberg
Finland	Local Institution	Espoo
Finland	Local Institution	Helsinki
Finland	Local Institution	Jyvaskyla
Finland	Local Institution	Kuopio
Finland	Local Institution	Tampere
France	Local Institution	Abbeville Cedex
France	Local Institution	Albi Cedex 09
France	Local Institution	Cholet
France	Local Institution	Grenoble Cedex 09
France	Local Institution	Langres Cedex
France	Local Institution	Paris Cedex 18
France	Local Institution	Sisteron
France	Local Institution	Toulon Cedex 09
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Berlin
Germany	Local Institution	Bonn
Germany	Local Institution	Essen
Germany	Local Institution	Frankfurt Am Main
Germany	Local Institution	Halle/saale
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Hamburg
Germany	Local Institution	Heidelberg
Germany	Local Institution	Heidelberg
Germany	Local Institution	Kassel
Germany	Local Institution	Koln
Germany	Local Institution	Leipzig
Germany	Local Institution	Magdeburg
Germany	Local Institution	Mainz
Germany	Local Institution	Mainz
Germany	Local Institution	Mannheim
Germany	Local Institution	Papenburg
Germany	Local Institution	Regensburg
Germany	Local Institution	Riesa
Germany	Local Institution	Witten
Germany	Local Institution	Wolmirstedt
Greece	Local Institution	Athens
Greece	Local Institution	Larissa
Greece	Local Institution	Thiva
Hong Kong	Local Institution	Chai Wan
Hong Kong	Local Institution	Hong Kong
Hong Kong	Local Institution	Shatin	NEW Territories
India	Local Institution	Ahmedabad
India	Local Institution	Bangalore
India	Local Institution	Bangalore	Karnataka
India	Local Institution	Banglore	Karnataka
India	Local Institution	Bikaner
India	Local Institution	Chennai	Tamil Nadu
India	Local Institution	Dhantoli	Nagpur
India	Local Institution	Hyderabad	Andhra Pradesh
India	Local Institution	Indore
India	Local Institution	Jaipur
India	Local Institution	Kottayam
India	Local Institution	Lucknow	Uttar Pradesh
India	Local Institution	Mumbai	Maharashtra
India	Local Institution	Mumbai	Maharashtra
India	Local Institution	Mysore	Karnataka
India	Local Institution	Nagpur,	Maharashtra
India	Local Institution	Nashik	Maharashtra
India	Local Institution	Pune	Maharashtra
India	Local Institution	Pune
Indonesia	Local Institution	Bandung
Indonesia	Local Institution	Denpasar
Indonesia	Local Institution	Jakarta
Indonesia	Local Institution	Jakarta
Indonesia	Local Institution	Jakarta Timur
Indonesia	Local Institution	Malang	Jawa-timur
Indonesia	Local Institution	Padang
Indonesia	Local Institution	Palembang
Indonesia	Local Institution	Surabaya
Indonesia	Local Institution	Yogyakarta
Israel	Local Institution	Afula
Israel	Local Institution	Ashkelon
Israel	Local Institution	Givatayim
Israel	Local Institution	Hadera
Israel	Local Institution	Haifa
Israel	Local Institution	Haifa
Israel	Local Institution	Holon
Israel	Local Institution	Nazareth
Israel	Local Institution	Nazareth
Israel	Local Institution	Petach-tikva
Israel	Local Institution	Safed
Israel	Local Institution	Tel Aviv
Italy	Local Institution	Ascoli Piceno
Italy	Local Institution	Chieti
Italy	Local Institution	Genova
Italy	Local Institution	Isernia
Italy	Local Institution	Lido Di Camaiore
Italy	Local Institution	Palermo
Italy	Local Institution	Perugia
Italy	Local Institution	San Daniele De Friuli (ud)
Italy	Local Institution	Sassari
Korea, Republic of	Local Institution	Busan
Korea, Republic of	Local Institution	Daegu
Korea, Republic of	Local Institution	Daejeon
Korea, Republic of	Local Institution	Goyang-si	Gyeonggi-do
Korea, Republic of	Local Institution	Gwangju
Korea, Republic of	Local Institution	Kuri-city	Kyunggi-do
Korea, Republic of	Local Institution	Seongnam-si	Gyeonggi-do
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Korea, Republic of	Local Institution	Seoul
Malaysia	Local Institution	Cheras	Kuala Lumpur
Malaysia	Local Institution	Johor Bahru	Johor
Malaysia	Local Institution	Kuala Lumpur
Malaysia	Local Institution	Kuala Lumpur
Malaysia	Local Institution	Kuching	Sarawak
Malaysia	Local Institution	Pulau Pinang	Pinang
Mexico	Local Institution	Acapulco	Guerrero
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Aguascalientes
Mexico	Local Institution	Atizapan De Zaragoza	Estado De Mexico
Mexico	Local Institution	Chihuahua
Mexico	Local Institution	Culiacan	Sinaloa
Mexico	Local Institution	Durango
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Guadalajara	Jalisco
Mexico	Local Institution	Hermosillo	Sonora
Mexico	Local Institution	Jalapa	Veracruz
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Mexico	Distrito Federal
Mexico	Local Institution	Monterrey	Nuevo Leon
Mexico	Local Institution	Queretaro
Mexico	Local Institution	San Luis Potosi
Mexico	Local Institution	San Luis Potosi, Slp	San Luis Potosi
Mexico	Local Institution	Zapopan	Jalisco
Norway	Local Institution	Fyllingsdal
Norway	Local Institution	Kongsberg
Norway	Local Institution	Oslo
Norway	Local Institution	Oslo
Philippines	Local Institution	Binan	Laguna
Philippines	Local Institution	Cagayan De Oro City
Philippines	Local Institution	Cavite
Philippines	Local Institution	Iligan City	Lanao DEL Norte
Philippines	Local Institution	Laoag City
Philippines	Local Institution	Manila
Philippines	Local Institution	Muntinlupa City
Philippines	Local Institution	Naga City	Camarines SUR
Poland	Local Institution	Czestochowa
Poland	Local Institution	Elblag
Poland	Local Institution	Gdynia
Poland	Local Institution	Gliwice
Poland	Local Institution	Gniewkowo
Poland	Local Institution	Grodzisk Mazowiecki
Poland	Local Institution	Inowroclaw
Poland	Local Institution	Kielce
Poland	Local Institution	Krakow
Poland	Local Institution	Krakow
Poland	Local Institution	Lodz
Poland	Local Institution	Piotrkow Trybunalski
Poland	Local Institution	Plock
Poland	Local Institution	Poznan
Poland	Local Institution	Pulawy
Poland	Local Institution	Siemianowice Slaskie
Poland	Local Institution	Skierniewice
Poland	Local Institution	Tarnow
Poland	Local Institution	Warsaw
Poland	Local Institution	Warszawa
Poland	Local Institution	Warszawa
Poland	Local Institution	Wegrow
Poland	Local Institution	Zabrze
Poland	Local Institution	Zarow
Russian Federation	Local Institution	Barnaul
Russian Federation	Local Institution	Chelyabinsk
Russian Federation	Local Institution	Ekaterinburg
Russian Federation	Local Institution	Ekaterinburg
Russian Federation	Local Institution	Kaluga	Anenki
Russian Federation	Local Institution	Kazan
Russian Federation	Local Institution	Kemerovo
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	Nizhniy Novgorod
Russian Federation	Local Institution	Novosibirsk
Russian Federation	Local Institution	Perm
Russian Federation	Local Institution	Perm
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	Samara
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	St.petersburg
Russian Federation	Local Institution	Tomsk
Russian Federation	Local Institution	Tumen
Russian Federation	Local Institution	Tver
Russian Federation	Local Institution	Yaroslavl
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
Singapore	Local Institution	Singapore
South Africa	Local Institution	Alberton	Gauteng
South Africa	Local Institution	Bellville, Cape Town	Western CAPE
South Africa	Local Institution	Bloemfontein	FREE State
South Africa	Local Institution	Bloemfontein	FREE State
South Africa	Local Institution	Cape Town	Western CAPE
South Africa	Local Institution	Pretoria
South Africa	Local Institution	Somerset West	Western CAPE
South Africa	Local Institution	Worcester	Western CAPE
Spain	Local Institution	Albacete
Spain	Local Institution	Hospitalet De Llobregat	Barcelona
Spain	Local Institution	Lugo	Galicia
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Torrevieja	Alicante
Spain	Local Institution	Valencia
Sweden	Local Institution	Goteborg
Sweden	Local Institution	Goteborg
Sweden	Local Institution	Molndal
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Stockholm
Sweden	Local Institution	Uppsala
Taiwan	Local Institution	Kaohsiung
Taiwan	Local Institution	Taichung
Taiwan	Local Institution	Tainan
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Taiwan	Local Institution	Taipei
Turkey	Local Institution	Isparta
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Istanbul
Turkey	Local Institution	Kirikkale
Ukraine	Local Institution	Dnipropetrovsk
Ukraine	Local Institution	Donetsk
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kharkiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
Ukraine	Local Institution	Kyiv
United Kingdom	Local Institution	Aberdeen	Aberdeenshire
United Kingdom	Local Institution	Barnsley	South Yorkshire
United Kingdom	Local Institution	Basildon	Essex
United Kingdom	Local Institution	Birmingham	West Midlands
United Kingdom	Local Institution	Blackpool	Lancashire
United Kingdom	Local Institution	Chesterfield	Derbyshire
United Kingdom	Local Institution	Chichester	West Sussex
United Kingdom	Local Institution	Craigavon	Portadown
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	Glasgow	Lanarkshire
United Kingdom	Local Institution	Kirkcaldy	Fife
United Kingdom	Local Institution	Larbert	Stirlingshire
United Kingdom	Local Institution	London	Greater London
United Kingdom	Local Institution	Newcastle Upon	Tyne And Wear
United Kingdom	Local Institution	Northampton	Northamptonshire
United Kingdom	Local Institution	Paisley	Renfrewshire
United Kingdom	Local Institution	Romford	Essex
United Kingdom	Local Institution	Worksop	Nottinghamshire
United States	Capital Cardiology Associates	Albany	New York
United States	Great Lakes Heart Center Of Alpena	Alpena	Michigan
United States	Cardiology Consultants Of Orange County Med. Group Inc	Anaheim	California
United States	Fox Valley Clinical Research Center, Llc	Aurora	Illinois
United States	Bay Pines Va Healthcare System	Bay Pines	Florida
United States	Lowcountry Medical Group, Llc	Beaufort	South Carolina
United States	Ira R. Friedlander, M.D.	Canton	Ohio
United States	Medical University Of South Carolina	Charleston	South Carolina
United States	Research Alliance, Inc.	Clearwater	Florida
United States	The Heart & Vascular Institute Of Florida	Clearwater	Florida
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	University Of Missouri	Columbia	Missouri
United States	Davis Heart & Lung Research Institute	Columbus	Ohio
United States	Southeast Regional Research Group	Columbus	Georgia
United States	Nyu Hudson Valley Cardiology	Cortlandt Manor	New York
United States	Kim A. Klancke, Md	Daytona Beach	Florida
United States	Henry Ford Hospital K-15	Detroit	Michigan
United States	Oregon Medical Group - Clinical Research	Eugene	Oregon
United States	Hunterdon Cardiovascular Associates	Flemington	New Jersey
United States	The Heart Group Pl	Fort Myers	Florida
United States	Internal Medicine Of Greer	Greer	South Carolina
United States	Cardiology Associates Of New Haven,Pc	Guilford	Connecticut
United States	Pentucket Medical Associates	Haverhill	Massachusetts
United States	Hillsboro Cardiology Pc	Hillsboro	Oregon
United States	Hutchinson Clinic, Pa	Hutchinson	Kansas
United States	Indiana Heart Physicians, Inc.	Indianapolis	Indiana
United States	The Care Group, Llc	Indianapolis	Indiana
United States	St. Vincent'S Ambulatory Care, Inc	Jacksonville	Florida
United States	Baptist Heart Specialists	Jacksonville Beach	Florida
United States	Glacier View Cardiology, Pc	Kalispell	Montana
United States	Knoxville Heart Group	Knoxville	Tennessee
United States	Dr. Jeffrey Chen	Lafayette	Louisiana
United States	Comprehensive Cardiology Consultants	Langhorne	Pennsylvania
United States	Terry V. Arnold, Md	Lexington	North Carolina
United States	Kaiser Permanente Medical Center, West Los Angeles	Los Angeles	California
United States	Marshfield Clinic	Marshfield	Wisconsin
United States	Michael F. Lesser, Md, Facc Osler Medical Inc.	Melbourne	Florida
United States	Long Island Heart Associates	Mineola	New York
United States	Mobile Heart Specialists, Pc	Mobile	Alabama
United States	Sentara York Clinical Research	Norfolk	Virginia
United States	North Chicago Va Medical Center	North Chicago	Illinois
United States	Integris Cardiovascular Physicians	Oklahoma City	Oklahoma
United States	South Oklahoma Heart Research	Oklahoma City	Oklahoma
United States	Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group	Palm Springs	California
United States	Michigan Heart And Vascular Specialists	Petoskey	Michigan
United States	Pinehurst Medical Clinic, Inc	Pinehurst	North Carolina
United States	Yogesh K. Paliwal Md	Pomona	California
United States	The Portland Clinic, Llp	Portland	Oregon
United States	San Diego Managed Care Group	Poway	California
United States	Roanoke Heart Institute, Plc	Roanoke	Virginia
United States	Academic Cardiology Associates	Rochester Hills	Michigan
United States	Salem Veterans Administration Medical Center	Salem	Virginia
United States	Peninsula Cardiology Associates, P.A.	Salisbury	Maryland
United States	University Of California, San Diego	San Diego	California
United States	Sanford Cardiology	Sanford	North Carolina
United States	Santa Rosa Cardiology	Santa Rosa	California
United States	Cardiovascular Center Of Sarasota	Sarasota	Florida
United States	Dr William Kufs	Saratoga Springs	New York
United States	Southeast Regional Research Group	Savannah	Georgia
United States	Grand View - Lehigh Valley Health Services	Sellersville	Pennsylvania
United States	Stamford Therapeutics Consortium	Stamford	Connecticut
United States	The Broward Heart Group, Pa	Tamarac	Florida
United States	Capital Cardiology Associates	Troy	New York
United States	Southwest Heart	Tucson	Arizona
United States	Tupelo Neurology Clinic, Pa	Tupelo	Mississippi
United States	North County Internal Medicine	Vista	California
United States	Walla Walla Clinic	Walla Walla	Washington
United States	West Chester Cardiology	West Chester	Pennsylvania
United States	Cardiology Consultants Of Philadelphia	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Pfizer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period	Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)	Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary	Event Rate for the Composite of Stroke of Any Type, Systemic Embolism, Myocardial Infarction, or Vascular Death During the Double-blind Treatment Period	Event rate=percent of participants with an event divided by the total participants in the arm.	Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary	Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death	Event rate=percent of participants with an event divided by the total participants in the arm.	Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary	Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period	Event rate=percent of participants with an event divided by the total participants in the arm.	First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010
Secondary	Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period	Event rate=percent of participants with an event divided by the total participants in the arm.	Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy)
Secondary	Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome	AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.	First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality	BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value =8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/µL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/µL), low if <0.8*BL and BL	First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)	LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL	First dose of study drug (Day 1) to 30 days after last dose of blinded study drug
Secondary	Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued)	ULN=upper limit of normal; LLN=lower limit of normal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL	First dose of study drug (Day 1) to 30 days after last dose of blinded study drug

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