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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
N/A
Not Enrolling
Both
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:

Interventional

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:

No

Principal Investigator

Bristol-Myers Squibb

Investigator Role:

Study Director

Investigator Affiliation:

Bristol-Myers Squibb

Authority:

United States: Food and Drug Administration

Study ID:

CV185-030

NCT ID:

NCT00412984

Start Date:

December 2006

Completion Date:

June 2011

Related Keywords:

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

Name

Location

Medical University of South CarolinaCharleston, South Carolina  29425-0721
Rhode Island HospitalProvidence, Rhode Island  02903
Loyola University Medical CenterMaywood, Illinois  60153
Henry Ford HospitalDetroit, Michigan  48202
Medical College of WisconsinMilwaukee, Wisconsin  53226
Bridgeport HospitalBridgeport, Connecticut  06610
William Beaumont HospitalRoyal Oak, Michigan  48073
University of MissouriColumbia, Missouri  65212
Broward General Medical CenterFort Lauderdale, Florida  33316
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Wilford Hall Medical CenterLackland Air Force Base, Texas  78236-5300
Elkhart Clinic, LLCElkhart, Indiana  46514-2098
North Memorial Health CareRobbinsdale, Minnesota  55422
University of MinnesotaMinneapolis, Minnesota  55455
Minneapolis VA Medical CenterMinneapolis, Minnesota  55417
Caritas St. Elizabeth's Medical CenterBrighton, Massachusetts  02135-2997
Washington VA Medical CenterWashington, District of Columbia  20422
Huntington HospitalHuntington, New York  11743
The Methodist HospitalHouston, Texas  77030
Truman Medical CenterKansas City, Missouri  64108
Volunteer Research GroupKnoxville, Tennessee  37920
Franklin Square HospitalBaltimore, Maryland  21237
Jacksonville Center for Clinical ResearchJacksonville, Florida  32216
The University of Texas MD Anderson Cancer CenterHouston, Texas  77030-4009
VA Greater Los Angeles Healthcare SystemLos Angeles, California  90073
Walla Walla ClinicWalla Walla, Washington  99362
Southern Arizona VA Health Care SystemTucson, Arizona  85723
Lahey Clinic Medical CenterBurlington, Massachusetts  01805
Aurora Health CareElkhorn, Wisconsin  53121
Melbourne Internal Medicine AssociatesMelbourne, Florida  32901
Johns Hopkins Bayview Medical CenterBaltimore, Maryland  21224
Cardiovascular Associates, PcBirmingham, Alabama  35209
Birmingham Heart Clinic P.C.Birmingham, Alabama  35235
Alabama Internal Medicine PcBirmingham, Alabama  35235
Heart Center, Inc.Huntsville, Alabama  35801
Mobile Heart Specialists, PcMobile, Alabama  36608
Clara V. Massey, MdMobile, Alabama  36617
Alaska Heart InstituteAnchorage, Alaska  99508
Internal Medicine Physicians Associates, P.C.Phoenix, Arizona  85006
Pima Research FoundationTucson, Arizona  85745
Southwest HeartTucson, Arizona  85710
Dr. Rajesh ShroffHot Springs, Arkansas  71913
Mary K. Richards, Md PaLittle Rock, Arkansas  72204
Advanced Clinical Reserach InstituteAnaheim, California  92801
Act/Cardiovascular Research InstituteBeverly Hills, California  90210
Capitol Interventional CardiologyCarmichael, California  95608
Escondido Cardiology Associates, Inc.Escondido, California  92025
William D. Bowden, D.O.Healdsburg, California  95448
La Mesa Cardiac Center, A Medical GroupLamesa, California  91942
Coastal CardiologyMission Viejo, California  92691
Kenneth W. Carr MdOceanside, California  92056
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med GroupPalm Springs, California  92262
Desert Cardiology Consultants Medical Group, IncRancho Mirage, California  92270
Regional Cardiolody AssociatesSacramento, California  95819
Northern California ResearchSacramento, California  95821
Sacramento Heart And Vascular Medical AssociatesSacramento, California  95825
Arrhythmia Consultants Of The Central Coast Medical GroupSanta Barbara, California  93105
Northern California Medical AssociatesSanta Rosa, California  95403
Progressive Clinical ResearchVista, California  92083
Cardivasclular Consultants Medical GroupWalnut Creek, California  94598
Shiva Heart Center Medical GroupWildomar, California  92595
Electrophysiology Associates, PcColorado Springs, Colorado  80910
Aurora Denver Cardiology Associates, P.C.Denver, Colorado  80218
Denver Va Medical CenterDenver, Colorado  80220
New West Physicians Clinical ResearchGolden, Colorado  80401
South Denver Cardiology Associates PcLittleton, Colorado  80120
Connecticut Clinical Research, LlcBridgeport, Connecticut  06606
Cardiology Associates Of New Haven,PcGuilford, Connecticut  06437
The William W. Backus HospitalNorwich, Connecticut  06360
Stamford Therapeutics ConsortiumStamford, Connecticut  06905
Chase Medical Research, LlcWaterbury, Connecticut  06708
Alfieri CardiologyNewark, Delaware  19713
George Washington University Medical Faculty AssociatesWashington, District of Columbia  20037
Medical Specialist Of The Palm BeachAtlantis, Florida  33462
Miami International Cardiology ConsultantsAventura, Florida  33180
David Charles Mishkel, Md, PaBoca Raton, Florida  33431
The Heart & Vascular Institute Of FloridaClearwater, Florida  33756
The Heart And Vascular Institute Of FloridaClearwater, Florida  33756
Cardiovascular Specialist Of South FloridaDavie, Florida  33324
Daytona Heart GroupDaytona Beach, Florida  32114
Cardiology Associates Of Fort Lauderdale, P.A.Fort Lauderdale, Florida  33308
Florida Heart AssociatesFt. Myers, Florida  33907
Florida Research Network, LlcGainesville, Florida  32605
Luis Tami, MdHollywood, Florida  33021
HealthworxHollywood, Florida  33021
Nature Coast Clinical ResearchInverness, Florida  34452
St. Vincent'S Ambulatory Care, IncJacksonville, Florida  32204
Jacksonville Heart Center, PaJacksonville, Florida  32207
St. Luke'S CardiologyJacksonville, Florida  32216
Jacksonville Cardiovascular CenterJacksonville, Florida  32216
Jacksonville Heart Center, P.A.Jacksonville Beach, Florida  32250
Cvms Research Institute, LlcJupiter, Florida  33458
Ricardo Bedoya, M.D.Jupiter, Florida  33458
Physicians Regional Medical GroupNaples, Florida  34119
Florida Heart GroupOrlando, Florida  32803
Alpha Medical ResearchOviedo, Florida  32765
Cardiology ConsultantsPensacola, Florida  32501
Niranjan Seshadri, MdSarasota, Florida  34232
Heart & Vascular Center Research, Inc.Sarasota, Florida  34239
Research, Inc.Vero Beach, Florida  32960
Cardiovascular Specialits, PcAtlanta, Georgia  30342
Augusta Cardiology Clinic, P.C.Augusta, Georgia  30901
Columbus Cardiology Associates,PcColumbus, Georgia  31909
Georgia Heart Specialists, L.L.C.Covington, Georgia  30014
Atlanta Institute For Medical Research, IncDecatur, Georgia  30030
Northeast Georgia Heart Center, PcGainesville, Georgia  30501
Wellstar Cardiovascular Medicine, PcMarietta, Georgia  30060
Fox Valley Clinical Research Center, LlcAurora, Illinois  60504
NmffChicago, Illinois  60611
Clinical Investigation Specialists, IncGurnee, Illinois  60031
Illinois Heart & Lung Research Center, ScNormal, Illinois  61761
Cpt. James A Lovell Federal Health Care CenterNorth Chicago, Illinois  60064
Community Clinical Research CenterAnderson, Indiana  46011
Premier Healthcare, LlcBloomington, Indiana  47403
Fort Wayne CardiologyFort Wayne, Indiana  46805
Lutheran Medical Group, LlcFort Wayne, Indiana  46804
St Francis Medical Group - Indiana Heart PhysiciansIndianapolis, Indiana  46237
The Care Group, Llc.Indianapolis, Indiana  46290
Dali, SammiMichigan City, Indiana  46360
Cardiology Associates, Inc.South Bend, Indiana  46601
Mcfarland Clinic PcAmes, 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 CenterLouisville, Kentucky  40202
Norton Cardiovascular AssociatesLouisville, Kentucky  40205
Owensboro Heart & VascularOwensboro, Kentucky  42303
Alexandria Cardiology ClinicAlexandria, Louisiana  71301
Cardiovascular Institute Of The SouthHouma, Louisiana  70360
Smith, Patel & Amkieh, LlcLacombe, Louisiana  70445
Imperial Calcasieu Medical Group, LlpLake Charles, Louisiana  70601
Cardiology Center, LlcMarrero, Louisiana  70072
Cardiology AssociatesShreveport, Louisiana  71105
Medical Research Institute, IncSlidell, Louisiana  70458
Louisiana Heart CenterSlidell, Louisiana  70458
Ventura Cardio. Cond. Med. Group, Inc.Ventura, Louisiana  93003
Central Maine Heart & Vascular InstituteLewiston, Maine  04240
Midatlantic Cardiovascular Associates, P.A.Baltimore, Maryland  21218
Midatlantic Cardiovascular Associates, PaBaltimore, Maryland  21237
Cardiovascular Specialists Of Central Maryland, P.A.Columbia, Maryland  21044
Clinical Associates ResearchReisterstown, Maryland  21136
Burlington Medical AssociatesBillerica, Massachusetts  01821
Neccr Internal Medicine & Cardiology Associates,LlcFall River, Massachusetts  02720
Pentucket Medical AssociatesHaverhill, Massachusetts  01830
Charles River Medical AssociatesNatick, Massachusetts  01760
Great Lakes Heart Center Of AlpenaAlpena, Michigan  49707
Thoracic And Cardiovascular Healthcare FoundationLansing, Michigan  48910
Advanced Cardiovascular Health Specialists, PcLivonia, Michigan  48154
Michigan Heart And Vascular SpecialistsPetoskey, Michigan  49770
Michigan Heart, P.C.Ypsilanti, Michigan  48197
Olive Branch Family Medical CenterOlive Branch, Mississippi  38654
Tupelo Neurology Clinic, PaTupelo, Mississippi  38801
Saint Luke'S Lipid And Diabetes Research CenterKansas City, Missouri  64111
Internal Medical Associates Of Grand Island, P.CGrand Island, Nebraska  68803
Nebraska Heart InstituteHastings, Nebraska  68901
Va Southern Nevada Healthcare SystemLas Vegas, Nevada  89106
Comprehensive Clinical ResearchBerlin, New Jersey  08009
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
Princeton Medical InstitutePrinceton, New Jersey  08540
Cardio Assoc Of Del Val, P.A.Sewell, New Jersey  08080
Central New Jersey CardiologySouth Plainfield, New Jersey  07080
Abq Health Partners, LlcAlbuquerque, New Mexico  87012
University Of New Mexico/University HospitalAlbuquerque, New Mexico  87131
Albany Assoc. In CardiologyAlbany, New York  12205
Cardiology Associates, PcBinghamton, New York  13905
Bruce L. Platt, MdBuffalo, New York  14215
Buffalo Heart Group, LlpBuffalo, New York  14215
Heart Care Center, P.C.East Syracuse, New York  13057
Sjh Cardiology AssociatesLiverpool, New York  13088
Long Island Heart AssociatesMineola, New York  11501
Saratoga Cardiology Associates, PcSaratoga Springs, New York  12866
Suburban CardiologyWilliamsville, New York  14221
Office Of Dr. KozinnWilliamsville, New York  14221
Asheville Cardiology AssociatesAsheville, North Carolina  28803
Kernodle Clinic, Inc.Burlington, North Carolina  27215
Carolina Cardiology Associates, PaHigh Point, North Carolina  27262
Pinehurst Medical Center, IncPinehurst, North Carolina  28374
Lillestol Research LlcFargo, North Dakota  58103
Akron Cardiology ConsultantsAkron, Ohio  44304
Christopher M. Johnson, D.O.Bucyrus, Ohio  44820
Community Health Care, Inc.Canal Fulton, Ohio  44614
Cardiology AssociatesCanton, Ohio  44710
The Carl & Edyth Lindner Center For R&E At The Christ HospCincinnati, Ohio  45219
Toledo Cardiology ConsultantsToledo, Ohio  43608
Family Practice Center Of Wadsworth, Inc.Wadsworth, Ohio  44281
Jack C. Va Medical CenterMuskogee, Oklahoma  74401
Plaza Medical Group, PcOklahoma City, Oklahoma  73112
Oklahoma Heart Hospital PhysiciansOklahoma City, Oklahoma  73120
Cor Clinical Research, LlcOklahoma City, Oklahoma  73103
Eminence Research, LlcOklahoma City, Oklahoma  73139
South Oklahoma Heart ResearchOklahoma City, Oklahoma  73135
Castlerock Clinical Research Consultants, LlcTulsa, Oklahoma  74136
St. Charles Health System, Inc.Bend, Oregon  97701
Oregon Medical Group - Clinical ResearchEugene, Oregon  97401
Hillsboro Cardiology PcHillsboro, Oregon  97123
Rogue Valley Physicians - Clinical Research GroupMedford, Oregon  97504
Abington Medical SpecialistsAbington, Pennsylvania  19001
Blair Medical Associates, Inc.Altoona, Pennsylvania  16602
Heritage Cardiology Assoc.Camp Hill, Pennsylvania  17011
Central Bucks CardiologyDoylestown, Pennsylvania  18901
Internal Medicine And Lipid Mgmt.Erie, Pennsylvania  16509
Kandra, Fierer, Kuskin AssociatesHarrisburg, Pennsylvania  17112
Pivotal Clinical Research, LlcHatfield, Pennsylvania  19440
Lycoming Internal Medicine Inc.Jerssey Shore, Pennsylvania  17740
Guthrie Clinic Ltd.Sayre, Pennsylvania  18840
Preferred Primary Care PhysiciansUniontown, Pennsylvania  15401
West Chester Cardiology, PcWest Chester, Pennsylvania  19380
Cardiology Consultants Of PhiladelphiaYardley, Pennsylvania  19067
Southeastern Research Associates, IncAnderson, South Carolina  29621
Lowcountry Medical GroupBeaufort, South Carolina  29906
Columbia Heart ClinicColumbia, South Carolina  29203
Upstate CardiologyGreenville, South Carolina  29607
Internal Medicine Of GreerGreer, South Carolina  29650
Palmetto Nephrology PaOrangeburg, South Carolina  29118
S. Carolina Pharmaceutical ResearchSpartanburg, South Carolina  29303
Avera Medical Associates ClinicPeirre, South Dakota  57501
Holston Medical GroupBristol, Tennessee  37620
Knoxville Heart GroupKnoxville, Tennessee  37916
Tennessee Center For Clinical TrialsTullahoma, Tennessee  37388
Amarillo Heart Clinical Research Institute Inc.Amarillo, Texas  79106
Corsicana Medical Research, PllcCorsicana, Texas  75110
Soltero Cardiovascular Research CenterDallas, Texas  75226
HeartplaceDallas, Texas  75230
Heart Center Of North TexasFt. Worth, Texas  76104
The Methodist Hospital Neurology InstituteHouston, Texas  77030
Center For Atrial FibrillationHouston, Texas  77030
Northwest Houston Cardiology, PaHouston, Texas  77070
Woodlands North Houston Heart CenterHouston, Texas  77090
Francisco R. MaislosHouston, Texas  77074
Regional Medical Center And Diagnostic ClinicsHumble, Texas  77338
Dcol Center For Clinical ResearchLongview, Texas  75605
North Dallas Research AssociatesMckinney, Texas  75069
Legacy Heart CenterPlano, Texas  75024
North Texas Medical ResearchPlano, Texas  75093
Bhs Specialty Network, IncSan Antonio, Texas  78217
Star Clinical TrailsSan Antonio, Texas  78229
Covenant Clinical Research, PaSan Antonio, Texas  78229
Edward Balli, Md, PaSeguin, Texas  78155
Northwest Heart CenterTomball, Texas  77375
The Univ. Of Texas Health Science Ctr. At TylerTyler, Texas  75708
Tyler Cardiovascular ConsultantsTyler, Texas  75701
Utah Cardiology P.CLayton, Utah  84041
Sentara York Clinical ResearchNorfolk, Virginia  23510
Medical Research InitiativesRichmond, Virginia  23220
Roanoke Heart Institute, PlcRoanoke, Virginia  24014
Cardiovascular AssociatesVirginia Beach, Virginia  23454
Daniel William Gottlieb, MdBurien, Washington  98166
Rockwood Clinic Research Cent.Spokane, Washington  99202
Lynn N. Smith, MdLewisburg, West Virginia  24901
Cardiology Associates Of Green Bay Ltd-Bellin HospitalGreen Bay, Wisconsin  54301
St.Mary'S HospitalMadison, Wisconsin  53715
Cardiology Assc. Of WaukeshaWaukesha, Wisconsin  53188