Last updated on January 2019

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


Brief description of study

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.

Detailed Study 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.

Clinical Study Identifier: NCT02415400

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University of Alabama at Birmingham

Birmingham, AL United States

Local Institution

Huntsville, AL United States

Arizona Heart Rhythm Center

Phoenix, AZ United States

Local Institution

Phoenix, AZ United States

Scottsdale Osborn Medical Center

Scottsdale, AZ United States

Southern Arizona VA Health Care System

Tucson, AZ United States

Comprehensive Cardiovascular Specialists

Alhambra, CA United States

Local Institution

Culver City, CA United States

Washington Township Medical Foundation

Fremont, CA United States

California Heart Specialist, Inc.

Huntington Beach, CA United States

Foundation For Cardiovascular Medicine

La Jolla, CA United States

Local Institution

La Mesa, CA United States

Local Institution

Long Beach, CA United States

Local Institution

Mission Viejo, CA United States

Local Institution

Rancho Mirage, CA United States

Local Institution

Reseda, CA United States

Manshadi Heart Institute

Stockton, CA United States

University of Colorado

Aurora, CO United States

Local Institution

Denver, CO United States

Colorado Heart and Vascular

Lakewood, CO United States

Local Institution

Norwalk, CT United States

Orlando Heart Specialists

Altamonte Springs, FL United States

Local Institution

Clearwater, FL United States

Daytona Heart Group

Daytona Beach, FL United States

Local Institution

Fort Lauderdale, FL United States

Local Institution

Jacksonville, FL United States

Tenet Florida Physician Services

Jupiter, FL United States

Local Institution

Lake Mary, FL United States

Local Institution

Miami, FL United States

Mediquest Research

Ocala, FL United States

Local Institution

Orlando, FL United States

CP Cardiology Partners

Palm Beach Gardens, FL United States

Bayfront Health St. Petersburg

Saint Petersburg, FL United States

Cardiology Partners

Wellington, FL United States

Athens Regional Cariology Group

Athens, GA United States

Local Institution

Atlanta, GA United States

Augusta University

Augusta, GA United States

Georgia Heart Specialists

Covington, GA United States

Local Institution

Cumming, GA United States

Local Institution

Tucker, GA United States

Saint Lukes Idaho Cardiology Associates

Boise, ID United States

Medicoricium, LLC

Fairview Heights, IL United States

Gateway Cardiology PC

Jerseyville, IL United States

South Suburban Cardiology

Olympia Fields, IL United States

Local Institution

Bloomington, IN United States

Elkhart Clinic LLC

Elkhart, IN United States

Roudebush VA Medical Center

Indianapolis, IN United States

Reid Hospital and Health Care Services

Richmond, IN United States

Midwest Cardiovascular Research Foundation

Davenport, IA United States

Northeast Iowa Family Practice Center

Waterloo, IA United States

Local Institution

Wichita, KS United States

Saint Elizabeth Healthcare

Crestview Hills, KY United States

University of Louisville

Louisville, KY United States

Alexandria Cardiology Clinic

Alexandria, LA United States

Imperial Health

Lake Charles, LA United States

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Minden, LA United States

Clinical Trials of America LA LLC - PPDS

Monroe, LA United States

Local Institution

New Orleans, LA United States

Clinical Trials of America-NC, LLC - PPDS

Shreveport, LA United States

Great Lakes Heart Center of Alpena

Alpena, MI United States

Henry Ford Hospital

Detroit, MI United States

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Lansing, MI United States

Covenant Center for the Heart

Saginaw, MI United States

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Edina, MN United States

Local Institution

Minneapolis, MN United States

Metropolitan Cardiology Consultants

Minneapolis, MN United States

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Rochester, MN United States

Hattiesburg Clinic

Hattiesburg, MS United States

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Jackson, MS United States

Cardiology Associates Research LLC

Tupelo, MS United States

Missouri Cardiovascular Specialists

Columbia, MO United States

Local Institution

Columbia, MO United States

Freeman Health System

Joplin, MO United States

St. Louis Heart and Vascular

Saint Louis, MO United States

Cox Health Systems

Springfield, MO United States

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Billings, MT United States

Bryan Heart Hospital

Lincoln, NE United States

HCP Clinical Research LLC

Las Vegas, NV United States

New Jersey Heart

Linden, NJ United States

Capital Cardiology Associates

Albany, NY United States

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Brooklyn, NY United States

Mount Sinai-St. Lukes

New York, NY United States

Hudson Valley Cardiovascular Practice, PC

Poughkeepsie, NY United States

Asheville Cardiology Associates PA

Asheville, NC United States

University of North Carolina School of Medicine

Chapel Hill, NC United States

Durham VA Medical Center

Durham, NC United States

Duke University Medical Center

Durham, NC United States

PMG Research of Wilmington

Wilmington, NC United States

Aultman Hospital

Canton, OH United States

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Columbus, OH United States

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Kettering, OH United States

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Willoughby, OH United States

Saint Vincent Hospital

Erie, PA United States

Heart Group

Lancaster, PA United States

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Natrona Heights, PA United States

Mercer Bucks Cardiology

Newton, PA United States

York Hospital

York, PA United States

Rhode Island Hospital

Providence, RI United States

Columbia Heart

Columbia, SC United States

Upstate Cardiology PA

Greenville, SC United States

Low Country Cardiology

North Charleston, SC United States

Cardiovascular Research of Knoxville

Knoxville, TN United States

Parkway Cardiology Associates PC

Oak Ridge, TN United States

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Dallas, TX United States

San Antonio Military Medical Center

Fort Sam Houston, TX United States

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Frisco, TX United States

Angiocardiac Care of Texas PA

Houston, TX United States

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Houston, TX United States

Grace Research, LLC

Huntsville, TX United States

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Katy, TX United States

Caprock Cardiac Center Research Institute

Lubbock, TX United States

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McKinney, TX United States

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Plano, TX United States

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San Antonio, TX United States

Mercury Medical LLC

San Antonio, TX United States

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Sealy, TX United States

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Sugar Land, TX United States

Victoria Heart and Vascular Center

Victoria, TX United States

University of Vermont

Burlington, VT United States

Virginia Heart

Falls Church, VA United States

Virginia Heart Group Ltd

Leesburg, VA United States

CJW Medical Center

Richmond, VA United States

St Mary's Medical Center

Huntington, WV United States

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Milwaukee, WI United States

Aspirus Research Institute

Wausau, WI United States

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Buenos Aires, Argentina

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Bahia Blanca, Argentina

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Ciudad Autonoma de Buenos Aires, Argentina

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Ciudad Autonoma De Buenos Aire, Argentina

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Mar del Plata, Argentina

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Opatija, Croatia

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Osijek, Croatia

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Sibenik, Croatia

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Liberec, Czechia

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Prague 8, Czechia

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Praha 5, Czechia

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Wilmington, DE United States

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Detroit, MI United States

Renown Regional Medical Center.

Reno, NV United States

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Goiania, Brazil

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Santo Andre, Brazil

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Le Coudray, France

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Freiburg, Germany

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San Diego, CA United States

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Jacksonville Beach, FL United States

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Natick, MA United States

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Ann Arbor, MI United States

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Germantown, TN United States

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Austin, TX United States

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Rio de Janeiro, Brazil

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Little Rock, AR United States

Trinity Medical WNY PC

Buffalo, NY United States

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Coronel Suarez, Argentina

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Vicente Lopez, Argentina

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Uberlandia, Brazil

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Itajai, Brazil

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Zlin, Czechia

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Holb?k, Denmark

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Chambray-les-Tours, France

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Ludenscheid, Germany

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Tubingen, Germany

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Gyor, Hungary

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Kharkiv, Ukraine

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Kyiv, Ukraine

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Lutsk, Ukraine

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Mykolaiv, Ukraine

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Mykolayiv, Ukraine

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Odesa, Ukraine

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Uzhhorod, Ukraine

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Zhaporizhzhya, Ukraine

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Stevenage, United Kingdom

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Birmingham, United Kingdom

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Dudley, United Kingdom

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Wolverhampton, United Kingdom

The Heart Center, Pc

Christiansted, Virgin Islands (U.S.)

Apex Cardiology

Jackson, TN United States

Recruitment Status: Closed


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