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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

Phase 3
18 Years
Not Enrolling
Atrial Fibrillation, Atrial Flutter

Thank you

Trial Information

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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Outcome Measure:

Number of Participants With First Event of Ischemic/Unspecified Stroke, Hemorrhagic Stroke, or Systemic Embolism (SE) During the Intended Treatment Period

Outcome Description:

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.

Outcome Time Frame:

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).

Safety Issue:


Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb


United States: Food and Drug Administration

Study ID:




Start Date:

December 2006

Completion Date:

June 2011

Related Keywords:

  • Atrial Fibrillation
  • Atrial Flutter
  • Atrial Fibrillation
  • Atrial Flutter



Medical University of South Carolina Charleston, South Carolina  29425-0721
Rhode Island Hospital Providence, Rhode Island  02903
Loyola University Medical Center Maywood, Illinois  60153
Henry Ford Hospital Detroit, Michigan  48202
Medical College of Wisconsin Milwaukee, Wisconsin  53226
Bridgeport Hospital Bridgeport, Connecticut  06610
William Beaumont Hospital Royal Oak, Michigan  48073
University of Missouri Columbia, Missouri  65212
Broward General Medical Center Fort Lauderdale, Florida  33316
University of Oklahoma Health Sciences Center Oklahoma City, Oklahoma  73104
Wilford Hall Medical Center Lackland Air Force Base, Texas  78236-5300
Elkhart Clinic, LLC Elkhart, Indiana  46514-2098
North Memorial Health Care Robbinsdale, Minnesota  55422
University of Minnesota Minneapolis, Minnesota  55455
Minneapolis VA Medical Center Minneapolis, Minnesota  55417
Caritas St. Elizabeth's Medical Center Brighton, Massachusetts  02135-2997
Washington VA Medical Center Washington, District of Columbia  20422
Huntington Hospital Huntington, New York  11743
The Methodist Hospital Houston, Texas  77030
Truman Medical Center Kansas City, Missouri  64108
Volunteer Research Group Knoxville, Tennessee  37920
Franklin Square Hospital Baltimore, Maryland  21237
Jacksonville Center for Clinical Research Jacksonville, Florida  32216
The University of Texas MD Anderson Cancer Center Houston, Texas  77030-4009
VA Greater Los Angeles Healthcare System Los Angeles, California  90073
Walla Walla Clinic Walla Walla, Washington  99362
Southern Arizona VA Health Care System Tucson, Arizona  85723
Lahey Clinic Medical Center Burlington, Massachusetts  01805
Aurora Health Care Elkhorn, Wisconsin  53121
Melbourne Internal Medicine Associates Melbourne, Florida  32901
Johns Hopkins Bayview Medical Center Baltimore, Maryland  21224
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Birmingham Heart Clinic P.C. Birmingham, Alabama  35235
Alabama Internal Medicine Pc Birmingham, Alabama  35235
Heart Center, Inc. Huntsville, Alabama  35801
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Clara V. Massey, Md Mobile, Alabama  36617
Alaska Heart Institute Anchorage, Alaska  99508
Internal Medicine Physicians Associates, P.C. Phoenix, Arizona  85006
Pima Research Foundation Tucson, Arizona  85745
Southwest Heart Tucson, Arizona  85710
Dr. Rajesh Shroff Hot Springs, Arkansas  71913
Mary K. Richards, Md Pa Little Rock, Arkansas  72204
Advanced Clinical Reserach Institute Anaheim, California  92801
Act/Cardiovascular Research Institute Beverly Hills, California  90210
Capitol Interventional Cardiology Carmichael, California  95608
Escondido Cardiology Associates, Inc. Escondido, California  92025
William D. Bowden, D.O. Healdsburg, California  95448
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Coastal Cardiology Mission Viejo, California  92691
Kenneth W. Carr Md Oceanside, California  92056
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Desert Cardiology Consultants Medical Group, Inc Rancho Mirage, California  92270
Regional Cardiolody Associates Sacramento, California  95819
Northern California Research Sacramento, California  95821
Sacramento Heart And Vascular Medical Associates Sacramento, California  95825
Arrhythmia Consultants Of The Central Coast Medical Group Santa Barbara, California  93105
Northern California Medical Associates Santa Rosa, California  95403
Progressive Clinical Research Vista, California  92083
Cardivasclular Consultants Medical Group Walnut Creek, California  94598
Shiva Heart Center Medical Group Wildomar, California  92595
Electrophysiology Associates, Pc Colorado Springs, Colorado  80910
Aurora Denver Cardiology Associates, P.C. Denver, Colorado  80218
Denver Va Medical Center Denver, Colorado  80220
New West Physicians Clinical Research Golden, Colorado  80401
South Denver Cardiology Associates Pc Littleton, Colorado  80120
Connecticut Clinical Research, Llc Bridgeport, Connecticut  06606
Cardiology Associates Of New Haven,Pc Guilford, Connecticut  06437
The William W. Backus Hospital Norwich, Connecticut  06360
Stamford Therapeutics Consortium Stamford, Connecticut  06905
Chase Medical Research, Llc Waterbury, Connecticut  06708
Alfieri Cardiology Newark, Delaware  19713
George Washington University Medical Faculty Associates Washington, District of Columbia  20037
Medical Specialist Of The Palm Beach Atlantis, Florida  33462
Miami International Cardiology Consultants Aventura, Florida  33180
David Charles Mishkel, Md, Pa Boca Raton, Florida  33431
The Heart & Vascular Institute Of Florida Clearwater, Florida  33756
The Heart And Vascular Institute Of Florida Clearwater, Florida  33756
Cardiovascular Specialist Of South Florida Davie, Florida  33324
Daytona Heart Group Daytona Beach, Florida  32114
Cardiology Associates Of Fort Lauderdale, P.A. Fort Lauderdale, Florida  33308
Florida Heart Associates Ft. Myers, Florida  33907
Florida Research Network, Llc Gainesville, Florida  32605
Luis Tami, Md Hollywood, Florida  33021
Healthworx Hollywood, Florida  33021
Nature Coast Clinical Research Inverness, Florida  34452
St. Vincent'S Ambulatory Care, Inc Jacksonville, Florida  32204
Jacksonville Heart Center, Pa Jacksonville, Florida  32207
St. Luke'S Cardiology Jacksonville, Florida  32216
Jacksonville Cardiovascular Center Jacksonville, Florida  32216
Jacksonville Heart Center, P.A. Jacksonville Beach, Florida  32250
Cvms Research Institute, Llc Jupiter, Florida  33458
Ricardo Bedoya, M.D. Jupiter, Florida  33458
Physicians Regional Medical Group Naples, Florida  34119
Florida Heart Group Orlando, Florida  32803
Alpha Medical Research Oviedo, Florida  32765
Cardiology Consultants Pensacola, Florida  32501
Niranjan Seshadri, Md Sarasota, Florida  34232
Heart & Vascular Center Research, Inc. Sarasota, Florida  34239
Research, Inc. Vero Beach, Florida  32960
Cardiovascular Specialits, Pc Atlanta, Georgia  30342
Augusta Cardiology Clinic, P.C. Augusta, Georgia  30901
Columbus Cardiology Associates,Pc Columbus, Georgia  31909
Georgia Heart Specialists, L.L.C. Covington, Georgia  30014
Atlanta Institute For Medical Research, Inc Decatur, Georgia  30030
Northeast Georgia Heart Center, Pc Gainesville, Georgia  30501
Wellstar Cardiovascular Medicine, Pc Marietta, Georgia  30060
Fox Valley Clinical Research Center, Llc Aurora, Illinois  60504
Nmff Chicago, Illinois  60611
Clinical Investigation Specialists, Inc Gurnee, Illinois  60031
Illinois Heart & Lung Research Center, Sc Normal, Illinois  61761
Cpt. James A Lovell Federal Health Care Center North Chicago, Illinois  60064
Community Clinical Research Center Anderson, Indiana  46011
Premier Healthcare, Llc Bloomington, Indiana  47403
Fort Wayne Cardiology Fort Wayne, Indiana  46805
Lutheran Medical Group, Llc Fort Wayne, Indiana  46804
St Francis Medical Group - Indiana Heart Physicians Indianapolis, Indiana  46237
The Care Group, Llc. Indianapolis, Indiana  46290
Dali, Sammi Michigan City, Indiana  46360
Cardiology Associates, Inc. South Bend, Indiana  46601
Mcfarland Clinic Pc Ames, Iowa  50010
Midwest Cardiology Associates , P.C. Overland Park, Kansas  66209
Central Cardiology Assoc. Elizabethtown, Kentucky  42701
New Lexington Clinic, P.S.C. Lexington, Kentucky  40504
Va Medical Center Louisville, Kentucky  40202
Norton Cardiovascular Associates Louisville, Kentucky  40205
Owensboro Heart & Vascular Owensboro, Kentucky  42303
Alexandria Cardiology Clinic Alexandria, Louisiana  71301
Cardiovascular Institute Of The South Houma, Louisiana  70360
Smith, Patel & Amkieh, Llc Lacombe, Louisiana  70445
Imperial Calcasieu Medical Group, Llp Lake Charles, Louisiana  70601
Cardiology Center, Llc Marrero, Louisiana  70072
Cardiology Associates Shreveport, Louisiana  71105
Medical Research Institute, Inc Slidell, Louisiana  70458
Louisiana Heart Center Slidell, Louisiana  70458
Ventura Cardio. Cond. Med. Group, Inc. Ventura, Louisiana  93003
Central Maine Heart & Vascular Institute Lewiston, Maine  04240
Midatlantic Cardiovascular Associates, P.A. Baltimore, Maryland  21218
Midatlantic Cardiovascular Associates, Pa Baltimore, Maryland  21237
Cardiovascular Specialists Of Central Maryland, P.A. Columbia, Maryland  21044
Clinical Associates Research Reisterstown, Maryland  21136
Burlington Medical Associates Billerica, Massachusetts  01821
Neccr Internal Medicine & Cardiology Associates,Llc Fall River, Massachusetts  02720
Pentucket Medical Associates Haverhill, Massachusetts  01830
Charles River Medical Associates Natick, Massachusetts  01760
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Thoracic And Cardiovascular Healthcare Foundation Lansing, Michigan  48910
Advanced Cardiovascular Health Specialists, Pc Livonia, Michigan  48154
Michigan Heart And Vascular Specialists Petoskey, Michigan  49770
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Olive Branch Family Medical Center Olive Branch, Mississippi  38654
Tupelo Neurology Clinic, Pa Tupelo, Mississippi  38801
Saint Luke'S Lipid And Diabetes Research Center Kansas City, Missouri  64111
Internal Medical Associates Of Grand Island, P.C Grand Island, Nebraska  68803
Nebraska Heart Institute Hastings, Nebraska  68901
Va Southern Nevada Healthcare System Las Vegas, Nevada  89106
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Cardiovascular Associates Of The Delware Valley, P.A. Elmer, New Jersey  08318
Cardiovascular Associates Of The Delaware Valley, P.A. Haddon Heights, New Jersey  08035
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Bruce L. Platt, Md Buffalo, New York  14215
Buffalo Heart Group, Llp Buffalo, New York  14215
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Long Island Heart Associates Mineola, New York  11501
Saratoga Cardiology Associates, Pc Saratoga Springs, New York  12866
Suburban Cardiology Williamsville, New York  14221
Office Of Dr. Kozinn Williamsville, New York  14221
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Kernodle Clinic, Inc. Burlington, North Carolina  27215
Carolina Cardiology Associates, Pa High Point, North Carolina  27262
Pinehurst Medical Center, Inc Pinehurst, North Carolina  28374
Lillestol Research Llc Fargo, North Dakota  58103
Akron Cardiology Consultants Akron, Ohio  44304
Christopher M. Johnson, D.O. Bucyrus, Ohio  44820
Community Health Care, Inc. Canal Fulton, Ohio  44614
Cardiology Associates Canton, Ohio  44710
The Carl & Edyth Lindner Center For R&E At The Christ Hosp Cincinnati, Ohio  45219
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Eminence Research, Llc Oklahoma City, Oklahoma  73139
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Castlerock Clinical Research Consultants, Llc Tulsa, Oklahoma  74136
St. Charles Health System, Inc. Bend, Oregon  97701
Oregon Medical Group - Clinical Research Eugene, Oregon  97401
Hillsboro Cardiology Pc Hillsboro, Oregon  97123
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Blair Medical Associates, Inc. Altoona, Pennsylvania  16602
Heritage Cardiology Assoc. Camp Hill, Pennsylvania  17011
Central Bucks Cardiology Doylestown, Pennsylvania  18901
Internal Medicine And Lipid Mgmt. Erie, Pennsylvania  16509
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Pivotal Clinical Research, Llc Hatfield, Pennsylvania  19440
Lycoming Internal Medicine Inc. Jerssey Shore, Pennsylvania  17740
Guthrie Clinic Ltd. Sayre, Pennsylvania  18840
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Cardiology Consultants Of Philadelphia Yardley, Pennsylvania  19067
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Lowcountry Medical Group Beaufort, South Carolina  29906
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Internal Medicine Of Greer Greer, South Carolina  29650
Palmetto Nephrology Pa Orangeburg, South Carolina  29118
S. Carolina Pharmaceutical Research Spartanburg, South Carolina  29303
Avera Medical Associates Clinic Peirre, South Dakota  57501
Holston Medical Group Bristol, Tennessee  37620
Knoxville Heart Group Knoxville, Tennessee  37916
Tennessee Center For Clinical Trials Tullahoma, Tennessee  37388
Amarillo Heart Clinical Research Institute Inc. Amarillo, Texas  79106
Corsicana Medical Research, Pllc Corsicana, Texas  75110
Soltero Cardiovascular Research Center Dallas, Texas  75226
Heartplace Dallas, Texas  75230
Heart Center Of North Texas Ft. Worth, Texas  76104
The Methodist Hospital Neurology Institute Houston, Texas  77030
Center For Atrial Fibrillation Houston, Texas  77030
Northwest Houston Cardiology, Pa Houston, Texas  77070
Woodlands North Houston Heart Center Houston, Texas  77090
Francisco R. Maislos Houston, Texas  77074
Regional Medical Center And Diagnostic Clinics Humble, Texas  77338
Dcol Center For Clinical Research Longview, Texas  75605
North Dallas Research Associates Mckinney, Texas  75069
Legacy Heart Center Plano, Texas  75024
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Bhs Specialty Network, Inc San Antonio, Texas  78217
Star Clinical Trails San Antonio, Texas  78229
Covenant Clinical Research, Pa San Antonio, Texas  78229
Edward Balli, Md, Pa Seguin, Texas  78155
Northwest Heart Center Tomball, Texas  77375
The Univ. Of Texas Health Science Ctr. At Tyler Tyler, Texas  75708
Tyler Cardiovascular Consultants Tyler, Texas  75701
Utah Cardiology P.C Layton, Utah  84041
Sentara York Clinical Research Norfolk, Virginia  23510
Medical Research Initiatives Richmond, Virginia  23220
Roanoke Heart Institute, Plc Roanoke, Virginia  24014
Cardiovascular Associates Virginia Beach, Virginia  23454
Daniel William Gottlieb, Md Burien, Washington  98166
Rockwood Clinic Research Cent. Spokane, Washington  99202
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Cardiology Associates Of Green Bay Ltd-Bellin Hospital Green Bay, Wisconsin  54301
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Cardiology Assc. Of Waukesha Waukesha, Wisconsin  53188