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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Steven Jones, Site 0621

Cardiovascular Associates of the Southeast, LLC
Birmingham, AL United States

Massoud Leesar, Site 0469

University of Alabama at Birmingham
Birmingham, AL United States

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Huntsville, AL United States

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Arizona Heart Rhythm Center
Phoenix, AZ United States

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Phoenix, AZ United States

Alan Tenaglia, Site 0332

Scottsdale Osborn Medical Center
Scottsdale, AZ United States

Huu Tam Truong, Site 0739

Southern Arizona VA Health Care System
Tucson, AZ United States

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Comprehensive Cardiovascular Specialists
Alhambra, CA United States

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Culver City, CA United States

Rohit Sehgal, Site 0212

Washington Township Medical Foundation
Fremont, CA United States

Majed Chane, Site 0565

California Heart Specialist, Inc.
Huntington Beach, CA United States

Maurice Buchbinder, Site 0471

Foundation For Cardiovascular Medicine
La Jolla, CA United States

Site 0542

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La Mesa, CA United States

Site 0941

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Long Beach, CA United States

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Mission Viejo, CA United States

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Rancho Mirage, CA United States

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Reseda, CA United States

Ramin Manshadi, Site 0529

Manshadi Heart Institute
Stockton, CA United States

Connie Hess, Site 0754

University of Colorado
Aurora, CO United States

Site 0606

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Denver, CO United States

John Thomas Svinarich, Site 0724

Colorado Heart and Vascular
Lakewood, CO United States

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Norwalk, CT United States

Nandkishore Ranadive, Site 0246

Orlando Heart Specialists
Altamonte Springs, FL United States

Marilyn King, Site 0455

Clearwater Cardiovascular and Interventional Consultants
Clearwater, FL United States

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Clearwater, FL United States

Vance Wilson, Site 0753

Daytona Heart Group
Daytona Beach, FL United States

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Rahul Aggarwal, Site 0484

Tenet Florida Physician Services
Jupiter, FL United States

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Ravikiran Korabathina, Site 0608

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Jean Foucauld, Site 0682

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Wellington, FL United States

Benjamin Holland, Site 0746

Athens Regional Cariology Group
Athens, GA United States

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Atlanta, GA United States

Gyanendra Sharma, Site 0684

Augusta University
Augusta, GA United States

Enrique Flores, Site 0766

Georgia Heart Specialists
Covington, GA United States

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Cumming, GA United States

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Tucker, GA United States

David Hinchman, Site 0744

Saint Lukes Idaho Cardiology Associates
Boise, ID United States

Omar Almousalli, Site 0604

Medicoricium, LLC
Fairview Heights, IL United States

Liwa Younis, Site 0446

Gateway Cardiology PC
Jerseyville, IL United States

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Olympia Fields, IL United States

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Bloomington, IN United States

Luisito Gonzales, Site 0247

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Jeetendra Patel, Site 0487

Roudebush VA Medical Center
Indianapolis, IN United States

Zulfiqar Mirza, Site 0553

Reid Hospital and Health Care Services
Richmond, IN United States

Nicolas Shammas, Site 0526

Midwest Cardiovascular Research Foundation
Davenport, IA United States

Phillip Horwitz, Site 0470

University of Iowa Stead Family Children's Hospital
Iowa City, IA United States

James Poock, Site 0729

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Alexandria, LA United States

Richard Gilmore, Site 0216

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Gregory Sampognaro, Site 0363

Clinical Trials of America LA LLC - PPDS
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Johnny Dy, Site 0445

Clinical Trials of America-NC, LLC - PPDS
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Khaled Nour, Site 0442

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Hattiesburg, MS United States

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Jackson, MS United States

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Tupelo, MS United States

Anthony Spaedy, Site 0482

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Columbia, MO United States

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Columbia, MO United States

Christopher Longnecker, Site 0564

Freeman Health System
Joplin, MO United States

George Kichura, Site 0759

St. Louis Heart and Vascular
Saint Louis, MO United States

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Cox Health Systems
Springfield, MO United States

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Billings, MT United States

Steve Krueger, Site 0531

Bryan Heart Hospital
Lincoln, NE United States

Erik Sirulnick, Site 0599

HCP Clinical Research LLC
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Jasjit Walia, Site 0429

New Jersey Heart
Linden, NJ United States

Lance Sullenberger, Site 0761

Capital Cardiology Associates
Albany, NY United States

Gioia Turitto, Site 0421

New York-Presbyterian Brooklyn Methodist Hospital
Brooklyn, NY United States

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Brooklyn, NY United States

Emad Aziz, Site 0591

Mount Sinai-St. Lukes
New York, NY United States

Anthony Patrello, Site 0760

Hudson Valley Cardiovascular Practice, PC
Poughkeepsie, NY United States

William Abernethy, Site 0001

Asheville Cardiology Associates PA
Asheville, NC United States

Weeranun Bode, Site 0733

University of North Carolina School of Medicine
Chapel Hill, NC United States

Thomas Povsic, Site 0709

Durham VA Medical Center
Durham, NC United States

Robert Harrison, Site 0735

Duke University Medical Center
Durham, NC United States

Matthew Janik, Site 0600

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Wilmington, NC United States

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Canton, OH United States

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Natrona Heights, PA United States

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Newton, PA United States

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Upstate Cardiology PA
Greenville, SC United States

Scott Woodfield, Site 0732

Low Country Cardiology
North Charleston, SC United States

Pradeep Singh, Site 0335

Carolina Cardiology Clinical Research Institute
Rock Hill, SC United States

Charles Treasure, Site 0747

Cardiovascular Research of Knoxville
Knoxville, TN United States

Malcolm Foster, Site 0601

Knoxville Health Managment Associates Cardiology PPM LLC
Knoxville, TN United States

Milan Sheth, Site 0322

Parkway Cardiology Associates PC
Oak Ridge, TN United States

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Christopher Pickett, Site 0211

San Antonio Military Medical Center
Fort Sam Houston, TX United States

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Angiocardiac Care of Texas PA
Houston, TX United States

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Houston, TX United States

Gaurav Aggarwala, Site 0687

Grace Research, LLC
Huntsville, TX United States

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Mohammad Shoukfeh, Site 0106

Caprock Cardiac Center Research Institute
Lubbock, TX United States

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Harish Chandna, Site 0541

Victoria Heart and Vascular Center
Victoria, TX United States

David Schneider, Site 0387

University of Vermont
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Tariq Haddad, Site 0708

Virginia Heart
Falls Church, VA United States

Subash Bazaz, Site 0784

Virginia Heart Group Ltd
Leesburg, VA United States

Michael Arcarese, Site 0767

CJW Medical Center
Richmond, VA United States

Aamir Cheema, Site 0528

St Mary's Medical Center
Huntington, WV United States

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Renown Regional Medical Center.
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Lumberton, NC United States

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Local Institution
Daegu, Korea, Republic of

Site 0556

Local Institution
Daejeon, Korea, Republic of

Site 0158

Local Institution
Gwang Ju, Korea, Republic of

Site 0465

Local Institution
Gyeonggi-do, Korea, Republic of

Site 0560

Local Institution
Incheon, Korea, Republic of

Site 0466

Local Institution
Seoul, Korea, Republic of

Site 0074

Local Institution
Torreon, Mexico

Site 0294

Local Institution
Leon, Mexico

Site 0383

Local Institution
Acapulco, Mexico

Site 0163

Local Institution
Guadalajara, Mexico

Site 0382

Local Institution
Zapopan, Mexico

Site 0169

Local Institution
Monterrey, Mexico

Site 0218

Local Institution
San Juan del Rio, Mexico

Site 0220

Local Institution
Culiacan, Mexico

Site 0162

Local Institution
Aguascalientes, Mexico

Site 0141

Local Institution
Durango, Mexico

Site 0147

Local Institution
Puebla, Mexico

Site 0146

Local Institution
Queretaro, Mexico

Site 0161

Local Institution
San Luis Potosi, Mexico

Site 0384

Local Institution
Veracruz, Mexico

Site 0737

Local Institution
's-hertogenbosch, Netherlands

Site 0391

Local Institution
Almelo, Netherlands

Site 0595

Local Institution
Amsterdam, Netherlands

Site 0415

Local Institution
Arnhem, Netherlands

Site 0298

Local Institution
Breda, Netherlands

Site 0357

Local Institution
Den Haag, Netherlands

Site 0257

Local Institution
Doetinchem, Netherlands

Site 0538

Local Institution
Ede, Netherlands

Site 0342

Local Institution
Emmen, Netherlands

Site 0295

Local Institution
Groningen, Netherlands

Site 0524

Local Institution
Hardenberg, Netherlands

Site 0297

Local Institution
Heerlen, Netherlands

Site 0260

Local Institution
Leiden, Netherlands

Site 0509

Local Institution
Leiderdorp, Netherlands

Site 0296

Local Institution
Maastricht, Netherlands

Site 0438

Local Institution
Nieuwegein, Netherlands

Site 0258

Local Institution
Roosendaal, Netherlands

Site 0259

Local Institution
Rotterdam, Netherlands

Site 0477

Local Institution
Tilburg, Netherlands

Site 0645

Local Institution
Uden, Netherlands

Site 0916

Local Institution
Veldhoven, Netherlands

Site 0771

Local Institution
Venlo, Netherlands

Site 0490

Local Institution
Bod?, Norway

Site 0299

Local Institution
Oslo, Norway

Site 0691

Local Institution
Skien, Norway

Site 0337

Local Institution
Stavanger, Norway

Site 0758

Local Institution
Tromso, Norway

Site 0405

Local Institution
Miraflores, Peru

Site 0343

Local Institution
Callao, Peru

Site 0385

Local Institution
Cusco, Peru

Site 0594

Local Institution
Lima, Peru

Site 0783

Local Institution
Bialystok, Poland

Site 0790

Local Institution
Bydgoszcz, Poland

Site 0491

Local Institution
Bytom, Poland

Site 0369

Local Institution
Chelm, Poland

Site 0525

Local Institution
Chojnice, Poland

Site 0301

Local Institution
Gdynia, Poland

Site 0305

Local Institution
Katowice, Poland

Site 0449

Local Institution
Kielce, Poland

Site 0431

Local Institution
Krakow, Poland

Site 0303

Local Institution
Lodz, Poland

Site 0794

Local Institution
Lubin, Poland

Site 0772

Local Institution
Opole, Poland

Site 0006

Local Institution
Plock, Poland

Site 0554

Local Institution
Poznan, Poland

Site 0304

Local Institution
Radom, Poland

Site 0076

Local Institution
Siemianowice Slaskie, Poland

Site 0459

Local Institution
Szczecin, Poland

Site 0780

Local Institution
Torun, Poland

Site 0237

Local Institution
Warszawa, Poland

Site 0793

Local Institution
Wloclawek, Poland

Site 0791

Local Institution
Wroclaw, Poland

Site 0432

Local Institution
Almada, Portugal

Site 0308

Local Institution
Aveiro, Portugal

Site 0309

Local Institution
Braga, Portugal

Site 0362

Local Institution
Coimbra, Portugal

Site 0436

Local Institution
Covilha, Portugal

Site 0392

Local Institution
Guimar?es, Portugal

Site 0306

Local Institution
Leiria, Portugal

Site 0307

Local Institution
Lisboa, Portugal

Site 0587

Local Institution
Senhora da Hora, Portugal

Site 0373

Local Institution
Vila Real, Portugal

Julio Baez Suarez, Site 0409

San Juan Bautista Medical School and Center
Caguas, Puerto Rico

Site 0231

Local Institution
Baia Mare, Romania

Site 0356

Local Institution
Brasov, Romania

Site 0310

Local Institution
Bucharest, Romania

Site 0035

Local Institution
Cluj Napoca, Romania

Site 0235

Local Institution
Cluj-Napoca, Romania

Site 0232

Local Institution
Craiova, Romania

Site 0230

Local Institution
Oradea, Romania

Site 0236

Local Institution
Pitesti, Romania

Site 0234

Local Institution
Sangiorgiu De Mures, Romania

Site 0229

Local Institution
Sibiu, Romania

Site 0393

Local Institution
Targoviste, Romania

Site 0004

Local Institution
Targu Mures, Romania

Site 0620

Local Institution
Timisoara, Romania

Site 0539

Local Institution
Tirgu Mures, Romania

Site 0936

Local Institution
Ekaterinburg, Russian Federation

Site 0077

Local Institution
Gatchina, Russian Federation

Site 0034

Local Institution
Kazan, Russian Federation

Site 0313

Local Institution
Krasnodar, Russian Federation

Site 0942

Local Institution
Moscow, Russian Federation

Site 0256

Local Institution
Novosibirsk, Russian Federation

Site 0312

Local Institution
Saint Petersburg, Russian Federation

Site 0935

Local Institution
Samara, Russian Federation

Site 0315

Local Institution
Saratov, Russian Federation

Site 0144

Local Institution
Sochi, Russian Federation

Site 0118

Local Institution
St. Petersburg, Russian Federation

Site 0938

Local Institution
Tyumen, Russian Federation

Site 0692

Local Institution
Belgarde, Serbia

Site 0648

Local Institution
Belgrade, Serbia

Site 0647

Local Institution
Nis, Serbia

Site 0665

Local Institution
Sremska Kamenica, Serbia

Site 0663

Local Institution
Uzice, Serbia

Site 0511

Local Institution
Banska Bystrica, Slovakia

Site 0693

Local Institution
Bardejov, Slovakia

Site 0397

Local Institution
Bratislava, Slovakia

Site 0461

Local Institution
Brezno, Slovakia

Site 0317

Local Institution
Kosice, Slovakia

Site 0227

Local Institution
Nitra, Slovakia

Site 0374

Local Institution
Spisska Nova Ves, Slovakia

Site 0462

Local Institution
Trebisov, Slovakia

Site 0207

Local Institution
Trencin, Slovakia

Site 0130

Local Institution
Majadahonda, Spain

Site 0143

Local Institution
Alicante, Spain

Site 0188

Local Institution
Almeria, Spain

Site 0797

Local Institution
Barcelona, Spain

Site 0187

Local Institution
Cadiz, Spain

Site 0186

Local Institution
Girona, Spain

Site 0208

Local Institution
Huelva, Spain

Site 0694

Local Institution
Islas Baleares, Spain

Site 0453

Local Institution
Madrid, Spain

Site 0413

Local Institution
Malaga, Spain

Site 0394

Local Institution
Marbella, Spain

Site 0425

Local Institution
Murcia, Spain

Site 0088

Local Institution
Palma de Mallorca, Spain

Site 0091

Local Institution
San Sebastian, Spain

Site 0089

Local Institution
Santiago de Compostela, Spain

Site 0590

Local Institution
Sevilla, Spain

Site 0087

Local Institution
Toledo, Spain

Site 0129

Local Institution
Valencia, Spain

Site 0090

Local Institution
Viladecans, Spain

Site 0189

Local Institution
Vizcaya, Spain

Site 0191

Local Institution
Eskilstuna, Sweden

Site 0375

Local Institution
Goteborg, Sweden

Site 0795

Local Institution
Jonkoping, Sweden

Site 0764

Local Institution
Ostersund, Sweden

Site 0192

Local Institution
Skelleftea, Sweden

Site 0774

Local Institution
Stockholm, Sweden

Site 0193

Local Institution
Uppsala, Sweden

Site 0513

Local Institution
Vaesteraas, Sweden

Site 0557

Local Institution
Bern, Switzerland

Site 0559

Local Institution
Geneve, Switzerland

Site 0417

Local Institution
Winterthur, Switzerland

Site 0588

Local Institution
Cherkasy, Ukraine

Site 0714

Local Institution
Chernivtsi, Ukraine

Site 0719

Local Institution
Dnipropetrovsk, Ukraine

Site 0679

Local Institution
Ivano-Frankivsk, Ukraine

Site 0717

Local Institution
Kharkiv, Ukraine

Site 0581

Local Institution
Kyiv, Ukraine

Site 0728

Local Institution
Lutsk, Ukraine

Site 0680

Local Institution
Mykolaiv, Ukraine

Site 0787

Local Institution
Mykolayiv, Ukraine

Site 0713

Local Institution
Odesa, Ukraine

Site 0741

Local Institution
Uzhhorod, Ukraine

Site 0712

Local Institution
Vinnytsia, Ukraine

Site 0718

Local Institution
Zhaporizhzhya, Ukraine

Site 0345

Local Institution
Bournemouth, United Kingdom

Site 0092

Local Institution
Kirkcaldy, United Kingdom

Site 0318

Local Institution
Stevenage, United Kingdom

Site 0939

Local Institution
Liverpool, United Kingdom

Site 0194

Local Institution
Northampton, United Kingdom

Site 0448

Local Institution
Doncaster, United Kingdom

Site 0730

Local Institution
Sheffield, United Kingdom

Site 0340

Local Institution
Dundee, United Kingdom

Site 0418

Local Institution
Newcastle Upon Tyne, United Kingdom

Site 0558

Local Institution
Birmingham, United Kingdom

Site 0912

Local Institution
Dudley, United Kingdom

Site 0776

Local Institution
Wolverhampton, United Kingdom

Dante Galiber, Site 0751

The Heart Center, Pc
Christiansted, Virgin Islands (U.S.)

Mohsin Alhaddad, Site 0736

Apex Cardiology
Jackson, TN United States

Recruitment Status: Closed


Brief Description Eligibility Contact Research Team


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