A Study of Apixaban in Patients With Atrial Fibrillation, Not Caused by a Heart Valve Problem, Who Are at Risk for Thrombosis (Blood Clots) Due to Having Had a Recent Coronary Event, Such as a Heart Attack or a Procedure to Open the Vessels of the Heart

Acute Coronary Syndromes Clinical Trial

Official title:

An Open-label, 2 x 2 Factorial, Randomized Controlled, Clinical Trial to Evaluate the Safety of Apixaban vs. Vitamin K Antagonist and Aspirin vs. Aspirin Placebo in Patients With Atrial Fibrillation and Acute Coronary Syndrome or Percutaneous Coronary Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415400
• Other study ID #: CV185-316
• Secondary ID: 2014-002004-24
• Status: Completed
• Phase: Phase 4
• Start date: June 4, 2015
• Est. completion date: November 10, 2018

Study information

• Verified date: June 2020
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Apixaban is safer than a Vitamin K Antagonist given for 6 months in terms of bleeding in patients with an irregular heart beat (atrial fibrillation) and a recent heart attack or a recent procedure to open up a blood vessel in the heart. All patients would also be taking a class of medicines called P2Y12 inhibitors (such as clopidogrel/Plavix) and be treated for up to 6 months. The primary focus will be a comparison of the bleeding risk of Apixaban, with or without aspirin, versus a Vitamin K antagonist, such as warfarin, with or without aspirin.

Description:

Patients will be recruited from either inpatient coronary care or general medical units, or recruited from outpatient cardiology offices.

Masking:

Apixaban: Open label.

VKA: Open label.

Acetylsalicylic acid film coated tablet: Double Blinded.

Placebo matching Acetylsalicylic acid film coated tablet: Double Blinded.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 4614
• Est. completion date: November 10, 2018
• Est. primary completion date: November 10, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Adults with either active or a history of non-valvular atrial fibrillation or flutter with the planned or existing use of an oral anticoagulant for prophylaxis of thromboembolism. In addition, subjects must have had an acute coronary syndrome or percutaneous coronary intervention with a stent within the prior 14 days

• Planned use of antiplatelet agents for at least 1 to 6 months

• Males and Females = 18 years of age

• Women of childbearing potential must have a negative serum or urine pregnancy test within 24 hours prior to the start of study drug

Exclusion Criteria:

• Conditions other than atrial fibrillation that require chronic anticoagulation. (e.g. prosthetic mechanical heart valve)

• Severe renal insufficiency (serum creatinine > 2.5 mg/dL or a calculated creatinine clearance < 30 mL/min

• Patients with a history of intracranial hemorrhage

• Patients have had or will undergo Coronary arterial bypass graft (CABG) for their index acute coronary syndrome (ACS) event

• Patients with known ongoing bleeding and patients with known coagulopathies

• Any contraindications or allergies to VKA, apixaban, or to intended P2Y12 antagonists or to aspirin

Related Conditions & MeSH terms

• Acute Coronary Syndrome
• Acute Coronary Syndromes
• Atrial Fibrillation
• Syndrome

Intervention

Drug:
• Apixaban

• vitamin K antagonist

• Acetylsalicylic acid

Other:
• Acetylsalicylic acid placebo

Locations

Country	Name	City	State
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	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires
Argentina	Local Institution	Buenos Aires	BUA
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad Autonoma de Buenos Aires	Buenos Aires
Argentina	Local Institution	Ciudad De Cordoba	Cordoba
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	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Cordoba
Argentina	Local Institution	Coronel Suarez	Buenos Aires
Argentina	Local Institution	Corrientes
Argentina	Local Institution	Lanus Oeste	Buenos Aires
Argentina	Local Institution	Mar del Plata	Buenos Aires
Argentina	Local Institution	Mar Del Plata	Buenos Aires
Argentina	Local Institution	Quilmes	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	Resistencia	Chaco
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Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Rosario	Santa FE
Argentina	Local Institution	Santa Fe
Argentina	Local Institution	Santa Fe
Argentina	Local Institution	Santa Fe
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Australia	Local Institution	Bedford Park
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Australia	Local Institution	Elizabeth Vale	South Australia
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Austria	Local Institution	Graz
Austria	Local Institution	Graz
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Austria	Local Institution	Linz
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Austria	Local Institution	Wien
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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
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Brazil	Local Institution	S?o Paulo	SAO Paulo
Brazil	Local Institution	S?o Paulo	SAO Paulo
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Salvador	Bahia
Brazil	Local Institution	Salvador	Bahia
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Brazil	Local Institution	Sao Paulo
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Korea, Republic of	Local Institution	Busan
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Korea, Republic of	Local Institution	Gwang Ju
Korea, Republic of	Local Institution	Incheon
Korea, Republic of	Local Institution	Seongnam-si
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
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Norway	Local Institution	Oslo
Norway	Local Institution	Skien
Norway	Local Institution	Stavanger
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Peru	Local Institution	Callao
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Poland	Local Institution	Bialystok
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Poland	Local Institution	Krakow
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Poland	Local Institution	Lodz
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Portugal	Local Institution	Almada
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Russian Federation	Local Institution	Ekaterinburg
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Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
Russian Federation	Local Institution	Moscow
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Russian Federation	Local Institution	Novosibirsk
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Russian Federation	Local Institution	Saratov
Russian Federation	Local Institution	Sochi
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	Tyumen
Russian Federation	Local Institution	Tyumen
Serbia	Local Institution	Belgarde
Serbia	Local Institution	Belgrade
Serbia	Local Institution	Belgrade
Serbia	Local Institution	Nis
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Slovakia	Local Institution	Kosice
Slovakia	Local Institution	Kosice
Slovakia	Local Institution	Kosice
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Spain	Local Institution	Alicante
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Spain	Local Institution	Cordoba
Spain	Local Institution	Huelva
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Madrid
Spain	Local Institution	Majadahonda	Madrid
Spain	Local Institution	Malaga
Spain	Local Institution	Marbella
Spain	Local Institution	Palma de Mallorca
Spain	Local Institution	San Sebastian
Spain	Local Institution	Valencia
Spain	Local Institution	Valencia
Sweden	Local Institution	Eskilstuna
Sweden	Local Institution	Goteborg
Sweden	Local Institution	Jonkoping
Sweden	Local Institution	Ostersund
Sweden	Local Institution	Skelleftea
Sweden	Local Institution	Stockholm
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Switzerland	Local Institution	Bern
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Switzerland	Local Institution	Winterthur
Ukraine	Local Institution	Cherkasy
Ukraine	Local Institution	Chernivtsi
Ukraine	Local Institution	Dnipropetrovsk
Ukraine	Local Institution	Ivano-Frankivsk
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	Lutsk
Ukraine	Local Institution	Lutsk
Ukraine	Local Institution	Mykolaiv
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Ukraine	Local Institution	Uzhhorod
Ukraine	Local Institution	Vinnytsia
Ukraine	Local Institution	Vinnytsia
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United Kingdom	Local Institution	Birmingham
United Kingdom	Local Institution	Bournemouth	Dorset
United Kingdom	Local Institution	Doncaster	South Yorkshire
United Kingdom	Local Institution	Dudley, West Midlands
United Kingdom	Local Institution	Dundee
United Kingdom	Local Institution	Kirkcaldy	Fife
United Kingdom	Local Institution	Liverpool	Merseyside
United Kingdom	Local Institution	Northampton	Northamptonshire
United Kingdom	Local Institution	Sheffield	South Yorkshire
United Kingdom	Local Institution	Stevenage	Hertfordshire
United Kingdom	Local Institution	Wolverhampton
United States	Capital Cardiology Associates	Albany	New York
United States	Alexandria Cardiology Clinic	Alexandria	Louisiana
United States	Comprehensive Cardiovascular Specialists	Alhambra	California
United States	Great Lakes Heart Center of Alpena	Alpena	Michigan
United States	Orlando Heart Specialists	Altamonte Springs	Florida
United States	Local Institution	Ann Arbor	Michigan
United States	Asheville Cardiology Associates PA	Asheville	North Carolina
United States	Athens Regional Cariology Group	Athens	Georgia
United States	Local Institution	Atlanta	Georgia
United States	Augusta University	Augusta	Georgia
United States	University Of Colorado	Aurora	Colorado
United States	Local Institution	Austin	Texas
United States	Local Institution	Austin	Texas
United States	Local Institution	Billings	Montana
United States	Cardiovascular Associates of the Southeast, LLC	Birmingham	Alabama
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Local Institution	Bloomington	Indiana
United States	Saint Lukes Idaho Cardiology Associates	Boise	Idaho
United States	Local Institution	Bradenton	Florida
United States	Local Institution	Brooklyn	New York
United States	New York-Presbyterian Brooklyn Methodist Hospital	Brooklyn	New York
United States	Buffalo Heart Group LLP	Buffalo	New York
United States	University of Vermont	Burlington	Vermont
United States	Aultman Hospital	Canton	Ohio
United States	University of North Carolina School of Medicine	Chapel Hill	North Carolina
United States	Clearwater Cardiovascular and Interventional Consultants	Clearwater	Florida
United States	Local Institution	Clearwater	Florida
United States	Columbia Heart	Columbia	South Carolina
United States	Local Institution	Columbia	Missouri
United States	Missouri Cardiovascular Specialists	Columbia	Missouri
United States	Local Institution	Columbus	Ohio
United States	Georgia Heart Specialists	Covington	Georgia
United States	Saint Elizabeth Healthcare	Crestview Hills	Kentucky
United States	Local Institution	Culver City	California
United States	Local Institution	Cumming	Georgia
United States	Local Institution	Dallas	Texas
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Daytona Heart Group	Daytona Beach	Florida
United States	Henry Ford Hospital	Detroit	Michigan
United States	Local Institution	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Durham VA Medical Center	Durham	North Carolina
United States	Elkhart Clinic LLC	Elkhart	Indiana
United States	Saint Vincent Hospital	Erie	Pennsylvania
United States	Medicoricium, LLC	Fairview Heights	Illinois
United States	Virginia Heart	Falls Church	Virginia
United States	Local Institution	Fort Lauderdale	Florida
United States	San Antonio Military Medical Center	Fort Sam Houston	Texas
United States	Washington Township Medical Foundation	Fremont	California
United States	Local Institution	Germantown	Tennessee
United States	Upstate Cardiology PA	Greenville	South Carolina
United States	Hattiesburg Clinic	Hattiesburg	Mississippi
United States	Angiocardiac Care of Texas PA	Houston	Texas
United States	Local Institution	Houston	Texas
United States	Local Institution	Houston	Texas
United States	St Mary's Medical Center	Huntington	West Virginia
United States	California Heart Specialist, Inc.	Huntington Beach	California
United States	Grace Research, LLC	Huntsville	Texas
United States	Local Institution	Huntsville	Texas
United States	Roudebush VA Medical Center	Indianapolis	Indiana
United States	University of Iowa Stead Family Children's Hospital	Iowa City	Iowa
United States	Local Institution	Jackson	Mississippi
United States	Research Associates of Jackson	Jackson	Tennessee
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Jacksonville	Florida
United States	Local Institution	Jacksonville Beach	Florida
United States	Gateway Cardiology PC	Jerseyville	Illinois
United States	Freeman Health System	Joplin	Missouri
United States	Tenet Florida Physician Services	Jupiter	Florida
United States	Local Institution	Kansas City	Kansas
United States	Local Institution	Katy	Texas
United States	Local Institution	Kettering	Ohio
United States	Cardiovascular Research of Knoxville	Knoxville	Tennessee
United States	Knoxville Health Managment Associates Cardiology PPM LLC	Knoxville	Tennessee
United States	Foundation For Cardiovascular Medicine	La Jolla	California
United States	Imperial Health	Lake Charles	Louisiana
United States	Local Institution	Lake Mary	Florida
United States	Colorado Heart and Vascular	Lakewood	Colorado
United States	Heart Group	Lancaster	Pennsylvania
United States	Local Institution	Lansing	Michigan
United States	HCP Clinical Research LLC	Las Vegas	Nevada
United States	Virginia Heart Group Ltd	Leesburg	Virginia
United States	Clinical Trials of America-NC, LLC - PPDS	Lenoir	North Carolina
United States	Bryan Heart Hospital	Lincoln	Nebraska
United States	New Jersey Heart	Linden	New Jersey
United States	Local Institution	Little Rock	Arkansas
United States	Local Institution	Long Beach	California
United States	University of Louisville	Louisville	Kentucky
United States	Caprock Cardiac Center Research Institute	Lubbock	Texas
United States	Duke Cardiology and Cardiovascular Surgery of Lumberton	Lumberton	North Carolina
United States	Local Institution	Miami	Florida
United States	Local Institution	Minden	Louisiana
United States	Metropolitan Cardiology Consultants	Minneapolis	Minnesota
United States	Clinical Trials of America LA LLC - PPDS	Monroe	Louisiana
United States	Local Institution	Natick	Massachusetts
United States	Mount Sinai-St. Lukes	New York	New York
United States	Mercer Bucks Cardiology	Newton	Pennsylvania
United States	Advocate Medical Group ? Cardiology and Pulmonology	Normal	Illinois
United States	Roper St. Francis Healthcare	North Charleston	South Carolina
United States	Local Institution	Norwalk	Connecticut
United States	Parkway Cardiology Associates PC	Oak Ridge	Tennessee
United States	Mediquest Research	Ocala	Florida
United States	South Suburban Cardiology	Olympia Fields	Illinois
United States	Local Institution	Orlando	Florida
United States	CP Cardiology Partners	Palm Beach Gardens	Florida
United States	Arizona Heart Rhythm Center	Phoenix	Arizona
United States	Local Institution	Phoenix	Arizona
United States	Local Institution	Phoenix	Arkansas
United States	Local Institution	Plano	Texas
United States	Hudson Valley Cardiovascular Practice, PC	Poughkeepsie	New York
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Local Institution	Rancho Mirage	California
United States	Renown Regional Medical Center.	Reno	Nevada
United States	CJW Medical Center	Richmond	Virginia
United States	Reid Hospital and Health Care Services	Richmond	Indiana
United States	Carolina Cardiology Clinical Research Institute	Rock Hill	South Carolina
United States	Covenant Center for the Heart	Saginaw	Michigan
United States	Gateway Cardiology PC	Saint Louis	Missouri
United States	St. Louis Heart and Vascular	Saint Louis	Missouri
United States	Bayfront Health St. Petersburg	Saint Petersburg	Florida
United States	Local Institution	San Antonio	Texas
United States	Mercury Medical LLC	San Antonio	Texas
United States	Local Institution	San Diego	California
United States	Scottsdale Osborn Medical Center	Scottsdale	Arizona
United States	Local Institution	Sealy	Texas
United States	Virginia Mason Medical Center	Seattle	Washington
United States	Cox Health Systems	Springfield	Missouri
United States	Manshadi Heart Institute	Stockton	California
United States	Local Institution	Sugar Land	Texas
United States	Local Institution	Tampa	Florida
United States	Local Institution	Torrance	California
United States	Local Institution	Tucker	Georgia
United States	Southern Arizona VA Health Care System	Tucson	Arizona
United States	Cardiology Associates Research LLC	Tupelo	Mississippi
United States	Victoria Heart and Vascular Center	Victoria	Texas
United States	Northeast Iowa Family Practice Center	Waterloo	Iowa
United States	Aspirus Research Institute	Wausau	Wisconsin
United States	Cardiology Partners	Wellington	Florida
United States	Local Institution	Wichita	Kansas
United States	Local Institution	Willoughby	Ohio
United States	Local Institution	Wilmington	Delaware
United States	PMG Research of Wilmington	Wilmington	North Carolina
United States	WellSpan York Hospital	York	Pennsylvania
Virgin Islands (U.S.)	Local Institution	Christiansted

Sponsors (3)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Duke Clinical Research Institute, Pfizer

Countries where clinical trial is conducted

United States,  Virgin Islands (U.S.),  Argentina,  Australia,  Austria,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  Colombia,  Croatia,  Czechia,  Denmark,  France,  Germany,  Hungary,  India,  Israel,  Italy,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Poland,  Portugal,  Puerto Rico,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Rate of International Society on Thrombosis and Haemostasis (ISTH) Major or Clinically Relevant Non-Major (CRNM) Bleeding With Apixaban Versus Vitamin K Antagonist (VKA) During the Treatment Period	Time to first ISTH major or CRNM bleeding during the 6-month period of treatment with Apixaban or VKA.; N is the number of participants treated with Apixaban or VKA.; n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.; Event rates are calculated based on the number of participants with major or CRNM bleeding divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Primary	The Rate of ISTH Major or CRNM Bleeding With Aspirin Versus no Aspirin During the Treatment Period	Time to first ISTH major or CRNM bleeding during the treatment period of 6 months with aspirin or placebo.; N is the number of participants with aspirin or placebo.; n is the number of participants treated with aspirin or placebo with major or CRNM bleeding in each treatment group during the 6-month period of treatment.; Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Secondary	Superiority on ISTH Major or CRNM Bleeding for Apixaban Versus VKA	Time to first occurrence during the time the participants were treated with Apixaban or VKA.; N is the number of participants treated with Apixaban or VKA.; n is the number of participants treated with Apixaban or VKA with major or CRNM bleeding in each treatment group during the 6-month period of treatment.; Event rates are calculated based on the number of participants with event of interest divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Secondary	The Rate of All-cause Death or All-cause Rehospitalization With Apixaban Versus VKA	Time to first all-cause death or all-cause hospitalization during the during the 6-month treatment period with Apixaban or VKA.; N is the number of participants treated with Apixaban or VKA.; n is the number of participants treated with Apixaban or VKA with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.; Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Secondary	The Rate of All-cause Death or All-cause Rehospitalization With Aspirn Versus no Aspirin	Time to first all-cause death or all-cause hospitalization during the 6-month period of treatment with aspirin or placebo.; N is the number of participants treated with aspirin or placebo.; n is the number of participants treated with aspirin or placebo with all-cause death or all-cause hospitalization in each treatment group during the 6-month period of treatment.; Event rates are calculated based on the number of participants with all-cause death or all-cause hospitalization divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Secondary	The Rate of the Composite Endpoint of Death or Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Apixaban Versus VKA	Time to first occurrence during the 6-month treatment period with Apixaban or VKA.; N is the number of participants treated with Apixaban or VKA.; n is the number of participants treated with Apixaban or VKA with death or ischemic events in each treatment group during the during the 6-month period of treatment.; Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months
Secondary	The Composite Endpoints of Death and Ischemic Events (Stroke, Myocardial Infarction, Stent Thrombosis, Urgent Revascularization) With Aspirin Versus no Aspirin	Time to first death or ischenic event during the 6-month treatment period with aspirin or placebo.; N is the number of participants treated with aspirin or placebo.; n is the number of participants treated with aspirin or placebo with death or ischemic events in each treatment group during the 6-month treatment period.; Event rates are calculated based on the number of participants with death or ischemic events divided by the sum of the number of days from the first dose of study drug to the event date or censoring date and expressed as percentage per year.	Approximately 6 months

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form