A Phase III Study of Apixaban in Patients With Atrial Fibrillation (AVERROES)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT00496769
First received: July 2, 2007
Last updated: July 8, 2014
Last verified: July 2014
  Purpose

The purpose of this clinical research study is to determine whether apixaban is more effective than acetylsalicylic acid in the prevention of strokes associated with patients with atrial fibrillation. The safety of this treatment will also be studied.


Condition Intervention Phase
Atrial Fibrillation
Drug: Apixaban
Drug: Acetylsalicylic acid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double-blind Trial

Resource links provided by NLM:


Further study details as provided by Bristol-Myers Squibb:

Primary Outcome Measures:
  • Event Rate of Stroke/Systemic Embolism During the Intended-treatment Period [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ] [ Designated as safety issue: No ]
    Event rate=percent of participants with an event divided by the total participants in the arm. Intended-treatment period=date of randomization to the efficacy cutoff date, which was to be the date on which at least 226 unrefuted original primary efficacy events occurred (date revised to May 28, 2010 following cessation of study for superior efficacy.)

  • Rate of Unrefuted Bleeding From First Dose of Double-blind Study Drug to First Occurence of Unrefuted Bleeding During the Double-blind Treatment Period [ Time Frame: Day 1 to first bleeding event up to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ] [ Designated as safety issue: Yes ]
    Event rate=percent of participants with an event divided by the total participants in the arm.


Secondary Outcome Measures:
  • Event Rates of Major Vascular Events (Stroke/Systemic Embolism, Myocardial Infarction, Death) in the Intended-treatment Period [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ] [ Designated as safety issue: No ]
    Event rate=percent of participants with an event divided by the total participants in the arm.

  • Event Rates for Major Bleeding, Major or Clinically Relevant Nonmajor (CNRM) Bleeding, and All Bleeding in the Double-blind Period [ Time Frame: First dose of study drug (Day 1) to the earlier of a patient's discontinuation of double-blind study drug or the attainment of at least 226 primary efficacy events up to May 28, 2010 ] [ Designated as safety issue: No ]
    Event rate=percent of participants with an event divided by the total participants in the arm.

  • Number of Participants With Serious Adverse Events (SAEs), Adverse Events (AEs), Bleeding AEs, Discontinuations Due to AEs, and Death as Outcome [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ] [ Designated as safety issue: Yes ]
    AE=any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that may not have a causal relationship with treatment. SAE=a medical event that at any dose results in death, persistent or significant disability/incapacity, or drug dependency/abuse; is life-threatening, an important medical event, or a congenital anomaly/birth defect; or requires or prolongs hospitalization.

  • Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ] [ Designated as safety issue: Yes ]
    BL=baseline, LLN=lower limit of normal, ULN=upper limit of normal. Hemoglobin (g/dL), low: BL>2 or value ≤8; hematocrit(%), low: <0.75*BL; erythrocytes (*10^6 cells/μL), low: <0.75*BL; platelet count (*10^9 cells/L),low: <100*10^9 cells/L; leukocytes (*10^3 cells/μL), low if <0.8*BL and BL<LLN or <LLN and BL >ULN or <0.75*LLN when BL is missing or LLN ≤BL≤ ULN, high if >1.2*BL and BL>ULN or >ULN when BL and BL<LLN or >1.25*ULN when BL is missing or LLN≤BL≤ULN; neutrophils (absolute), low: <1.0*10^3 cells/μL; eosinophils (absolute), high: >0.750*10^3 cells/μL; basophils (absolute), high: >0.4*10^3 cells/μL; monocytes (absolute), high: 2*10^3 cells/μL; lymphocytes (absolute), low if <0.75*10^3 cells/μL, high if >7.50*10^3 cells/μL; ALP (U/L), high: 2*ULN; AST (U/L), high: 3*ULN; AST (U/L), high: 3*ULN; bilirubin, total (mg/dL), high: >2*ULN; bilirubin, direct (mg/dL), high: 1.5*ULN; BUN (mg/dL), high:>2*ULN; creatinine (mg/dL), high: >1.5*ULN.

  • Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ] [ Designated as safety issue: Yes ]
    LLN=lower limit of normal; ULN=upper limit of normal; BL=baseline. Sodium, serum (mEq/L):low if <0.95*BL and BL<LLN or <LLN and BL>ULN or <0.95*LLN when BL missing or LLN ≤BL≤ULN, high if >1.05*BL and BL>ULN or >ULN and BL<LLN or >1.05*ULN when BL missing or LLN≤BL≤ULN; potassium(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL and BL>ULN or>ULN and BL<LLN or >1.10*ULN when BL missing or LLN≤BL≤ULN; chloride(mEq/L):low if <0.90*BL and BL<LLN or <LLN and BL>ULN or <0.90*LLN if BL missing or LLN≤BL ≤ULN, high if >1.10*BL and BL>ULN or >ULN and BL<LLN or >1.10* ULN if BL missing or LLN≤BL≤ULN; calcium(mg/dL):low if <0.75*BL and BL<LLN or <LLN and BL>ULN or <0.80*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL and BL>ULN or >ULN if BL<LLN or >1.20*ULN if BL missing or LLN≤BL≤ULN ; bicarbonate(mEq/L):low if <0.75*BL when BL<LLN or <LLN when BL>ULN or <0.75*LLN if BL missing or LLN≤BL≤ULN, high if >1.25*BL when BL>ULN or >ULN

  • Number of Participants With Laboratory Test Results Meeting the Criteria for Marked Abnormality (Continued) [ Time Frame: First dose of study drug (Day 1) to 30 days after last dose of blinded study drug ] [ Designated as safety issue: Yes ]
    ULN=upper limit of normal; LLN=lower limit ofnormal; BL=baseline. Creatine kinase (U/L), high:>5*ULN; protein, total(g/L):low if <0.90*BL when BL<LLN or <LLN when B >ULN or <0.90*LLN when BL is missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN when BL<LLN or >1.10*ULN if BL missing or LLN≤BL≤ULN.Protein,total(g/L): low if <0.90*BL if BL<LLN or <LLN if BL>ULN or <0.90*LLN if BL missing or LLN≤BL≤ULN, high if >1.10*BL if BL>ULN or >ULN if BL<LLN or >1.10*ULN if BL or LLN≤BL≤ULN; glucose, serum fasting (mg/dL): low if <0.8*BL if BL<LLN or <LLN when BL>ULN or <0.8*LLN when BL missing or LLN≤BL≤ULN, high if >2*BL when BL>ULN or >ULN when BL<LLN or >1.5*ULN if BL missing or LLN≤BL≤ULN; uric acid (mg/dL), high: >2*BL and BL>ULN or>1.5*ULN when BL missing or BL≤ULN; glucose, urine, high; protein, urine, high; blood, urine, high; leukocyte esterase, urine, high; RBC count, urine (Hpf), high; WBC count, urine (Hpf), high: ≥2 if BL=missing,=0 or =0.5 or if ≥3 if BL=1, or if ≥4 and BL≥2.

  • Event Rate of All-cause Death; Net Clinical Benefit-Composite of Stroke, Systemic Embolism, Myocardial Infarction, Vascular Death, and Major Bleeding; and Vascular Death [ Time Frame: Randomization to efficacy cutoff date of May 28, 2010 (date revised following cessation of study for superior efficacy) ] [ Designated as safety issue: No ]
    Event rate=percent of participants with an event divided by the total participants in the arm.


Enrollment: 6421
Study Start Date: August 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Apixaban Drug: Apixaban
Tablets, oral, 5 mg (2.5 mg in patients meeting any 2 of the following criteria: 80 years of age and older, weight of 60 kilograms or less, and a serum creatinine level of 1.5 mg/dL or higher), twice daily, up to 156 weeks
Other Name: BMS-562247
Active Comparator: Acetylasalicylic acid Drug: Acetylsalicylic acid
Tablets, oral, 81-324 mg, once daily, up to 156 weeks

Detailed Description:

An optional Long-term Open-label Extension Phase of treatment with apixaban will be provided for qualifying participants following the conclusion of the double-blind phase

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Male and female
  • Age of 50 years or older
  • Permanent, paroxysmal, or persistent atrial fibrillation (at screening or within 6 months prior to enrollment) documented by 12-lead electrocardiogram)
  • At least 1 of the following risk factors for stroke:

    • Prior stroke or transient ischemic attack
    • Age of 75 years or older
    • Arterial hypertension on treatment
    • Diabetes mellitus
    • Heart failure (New York Health Authority Class 2 or greater at time of enrollment)
    • Left ventricular ejection fraction of 35% or less, documented within 6 months of enrollment
    • Peripheral arterial disease (previous arterial revascularization, limb or foot amputation, or current intermittent claudication with ankle-arm systolic blood pressure ratio <0.9)
  • Not currently receiving vitamin K antagonist therapy for 1 of the following reasons:

    • Previous vitamin K antagonist therapy demonstrated as unsuitable and discontinued
    • Vitamin K antagonist therapy not previously used but expected unsuitable

Key Exclusion Criteria:

  • Women who are pregnant or breast feeding
  • Women of child bearing potential who are unwilling to meet the study requirements for pregnancy testing or are unwilling or unable to use an acceptable method to avoid pregnancy
  • Atrial fibrillation due to reversible causes, such as thyrotoxicosis or pericarditis
  • Valvular disease requiring surgery
  • Planned ablation procedure for atrial fibrillation to be performed within 3 months
  • Conditions other than atrial fibrillation that require chronic anticoagulation (such as, prosthetic mechanical heart valve, venous thromboembolism)
  • Patients with serious bleeding in the last 6 months or at high risk for bleeding, including but not limited to those with:

    • Active peptic ulcer disease
    • Platelet count <100,000/mm^3 or hemoglobin <10g/dL
    • Recent stroke (within 10 days)
    • Documented hemorrhagic tendencies or blood dyscrasias
  • Current alcohol or drug abuse or psychosocial reasons that make study participation impractical
  • Severe comorbid condition with life expectancy <1 year
  • Severe renal insufficiency; any patient with a serum creatinine level >2.5 mg/dL or a calculated creatinine clearance <25 mL/min is excluded
  • Alanine transaminase or aspartate aminotransferase levels >2 times upper limit of normal (ULN) or a total bilirubin level >1.5 times ULN (unless an alternative causative factor [such as Gilbert's syndrome] is identified)
  • Allergy or adverse reaction to acetylsalicylic acid
  • Required treatment with a thienopyridine (clopidogrel or ticlopidine)
  • Prisoners or participants who are compulsory detained (involuntarily incarcerated)
  • Use of an investigational drug or device within the past 30 days or prior randomization into an apixaban clinical study
  • Patients who are compulsorily detained for treatment for a psychiatric or physical illness
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00496769

  Hide Study Locations
Locations
United States, Alabama
Mobile Heart Specialists, Pc
Mobile, Alabama, United States, 36608
United States, Arizona
Southwest Heart
Tucscon, Arizona, United States, 85710
United States, California
Cardiology Consultants Of Orange County Med. Group Inc
Anaheim, California, United States, 92801
Kaiser Permanente Medical Center, West Los Angeles
Los Angeles, California, United States, 90034
Desert Med Grp Inc, Dba Desert Oasis Healthcare Med Group
Palm Springs, California, United States, 92262
Yogesh K. Paliwal Md
Pomona, California, United States, 91767
San Diego Managed Care Group
Poway, California, United States, 92064
University Of California, San Diego
San Diego, California, United States, 92103
Santa Rosa Cardiology
Santa Rosa, California, United States, 95405
North County Internal Medicine
Vista, California, United States, 92083
United States, Connecticut
Cardiology Associates Of New Haven,Pc
Guilford, Connecticut, United States, 06437
Stamford Therapeutics Consortium
Stamford, Connecticut, United States, 06905
United States, Florida
Bay Pines Va Healthcare System
Bay Pines, Florida, United States, 33744
Research Alliance, Inc.
Clearwater, Florida, United States, 33756
The Heart & Vascular Institute Of Florida
Clearwater, Florida, United States, 33756
Kim A. Klancke, Md
Daytona Beach, Florida, United States, 32114
The Heart Group Pl
Fort Myers, Florida, United States, 33908
St. Vincent'S Ambulatory Care, Inc
Jacksonville, Florida, United States, 32204
Baptist Heart Specialists
Jacksonville Beach, Florida, United States, 32250
Michael F. Lesser, Md, Facc Osler Medical Inc.
Melbourne, Florida, United States, 32901
Cardiovascular Center Of Sarasota
Sarasota, Florida, United States, 34239
The Broward Heart Group, Pa
Tamarac, Florida, United States, 33321
United States, Georgia
Southeast Regional Research Group
Columbus, Georgia, United States, 31904
Southeast Regional Research Group
Savannah, Georgia, United States, 31406
United States, Illinois
Fox Valley Clinical Research Center, Llc
Aurora, Illinois, United States, 60504
North Chicago Va Medical Center
North Chicago, Illinois, United States, 60064
United States, Indiana
The Care Group, Llc
Indianapolis, Indiana, United States, 46290
Indiana Heart Physicians, Inc.
Indianapolis, Indiana, United States, 46237
United States, Kansas
Hutchinson Clinic, Pa
Hutchinson, Kansas, United States, 67502
United States, Louisiana
Dr. Jeffrey Chen
Lafayette, Louisiana, United States, 70506
United States, Maryland
Peninsula Cardiology Associates, P.A.
Salisbury, Maryland, United States, 21804
United States, Massachusetts
Pentucket Medical Associates
Haverhill, Massachusetts, United States, 01830
United States, Michigan
Great Lakes Heart Center Of Alpena
Alpena, Michigan, United States, 49707
Henry Ford Hospital K-15
Detroit, Michigan, United States, 48202
Michigan Heart And Vascular Specialists
Petoskey, Michigan, United States, 49770
Academic Cardiology Associates
Rochester Hills, Michigan, United States, 48307
United States, Mississippi
Tupelo Neurology Clinic, Pa
Tupelo, Mississippi, United States, 38801
United States, Missouri
University Of Missouri
Columbia, Missouri, United States, 65212
Missouri Cardiovascular Specialists
Columbia, Missouri, United States, 65201
United States, Montana
Glacier View Cardiology, Pc
Kalispell, Montana, United States, 59901
United States, New Jersey
Hunterdon Cardiovascular Associates
Flemington, New Jersey, United States, 08822
United States, New York
Capital Cardiology Associates
Albany, New York, United States, 12211
Nyu Hudson Valley Cardiology
Cortlandt Manor, New York, United States, 10567
Long Island Heart Associates
Mineola, New York, United States, 11501
Dr William Kufs
Saratoga Springs, New York, United States, 12866
Capital Cardiology Associates
Troy, New York, United States, 12180
United States, North Carolina
Terry V. Arnold, Md
Lexington, North Carolina, United States, 27293
Pinehurst Medical Clinic, Inc
Pinehurst, North Carolina, United States, 28374
Sanford Cardiology
Sanford, North Carolina, United States, 27330
United States, Ohio
Ira R. Friedlander, M.D.
Canton, Ohio, United States, 44710
Davis Heart & Lung Research Institute
Columbus, Ohio, United States, 43210
United States, Oklahoma
Integris Cardiovascular Physicians
Oklahoma City, Oklahoma, United States, 73112
South Oklahoma Heart Research
Oklahoma City, Oklahoma, United States, 73135
United States, Oregon
Oregon Medical Group - Clinical Research
Eugene, Oregon, United States, 97401
Hillsboro Cardiology Pc
Hillsboro, Oregon, United States, 97123
The Portland Clinic, Llp
Portland, Oregon, United States, 97205
United States, Pennsylvania
Comprehensive Cardiology Consultants
Langhorne, Pennsylvania, United States, 19047
Grand View - Lehigh Valley Health Services
Sellersville, Pennsylvania, United States, 18960
West Chester Cardiology
West Chester, Pennsylvania, United States, 19380
Cardiology Consultants Of Philadelphia
Yardley, Pennsylvania, United States, 19067
United States, South Carolina
Lowcountry Medical Group, Llc
Beaufort, South Carolina, United States, 29906
Medical University Of South Carolina
Charleston, South Carolina, United States, 29425
Internal Medicine Of Greer
Greer, South Carolina, United States, 29650
United States, Tennessee
Knoxville Heart Group
Knoxville, Tennessee, United States, 37916
United States, Virginia
Sentara York Clinical Research
Norfolk, Virginia, United States, 23510
Roanoke Heart Institute, Plc
Roanoke, Virginia, United States, 24014
Salem Veterans Administration Medical Center
Salem, Virginia, United States, 24153
United States, Washington
Walla Walla Clinic
Walla Walla, Washington, United States, 99362
United States, Wisconsin
Marshfield Clinic
Marshfield, Wisconsin, United States, 54449
Argentina
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Adrogue, Buenos Aires, Argentina, 1846
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Rosario, Santa Fe, Argentina, S2000CVB
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Rosario, Santa Fe, Argentina, S2001ODA
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San Miguel De Tucuman, Tucuman, Argentina, T4000JCU
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Buenos Aires, Argentina, 1221
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Cordoba, Argentina, 5000
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Corrientes, Argentina, 3400
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Salta, Argentina, A4406CLA
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Santa Fe, Argentina, 3000
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Coffs Harbour, New South Wales, Australia, 2450
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Concord, New South Wales, Australia, 2139
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Gosford, New South Wales, Australia, 2250
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Kingswood, New South Wales, Australia, 2747
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Auchenflower, Queensland, Australia, 4066
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Kippa Ring, Queensland, Australia, 4021
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Woolloongabba, Queensland, Australia, 4102
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Geelong, Victoria, Australia, 3220
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Aalst, Belgium, 9300
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Brasschaat, Belgium, 2930
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Brussel, Belgium, 1090
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Bruxelles, Belgium, 1070
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De Pinte, Belgium, 9840
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Genk, Belgium, 3600
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Huy, Belgium, 4500
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Roeselare, Belgium, 8800
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Turnhout, Belgium, 2300
Brazil
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Salvador, Bahia, Brazil, 41810
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Salvador, Bahia, Brazil, 40144
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Belo Horizonte, Minas Gerais, Brazil, 30150
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Uberaba, Minas Gerais, Brazil, 38010
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Uberaba, Minas Gerais, Brazil, 38025
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Campina Grande Do Sul, Parana, Brazil, 83430
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Curitiba, Parana, Brazil, 80010
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Curitiba, Parana, Brazil, 80730
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Maringa, Parana, Brazil, 87015
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Belem, Para, Brazil, 66087
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Natal, Rio Grande Do Norte, Brazil, 59020
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Porto Alegre, Rio Grande Do Sul, Brazil, 90020
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Porto Alegre, Rio Grande Do Sul, Brazil, 90110
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Porto Alegre, Rio Grande Do Sul, Brazil, 91350
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Porto Alegre, Rio Grande Do Sul, Brazil, 90610
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Porto Alegre, Rio Grande Do Sul, Brazil, 90035
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Porto Alegre, Rio Grande Do Sul, Brazil, 90620
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Blumenau, Santa Catarina, Brazil, 89010
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Sao Jose, Santa Catarina, Brazil, 88103
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Botucatu, Sao Paulo, Brazil, 18600
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Campinas, Sao Paulo, Brazil, 13059
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Marilia, Sao Paulo, Brazil, 17519
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Marilia, Sao Paulo, Brazil, 17515
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San Jose- Do Rio Preto, Sao Paulo, Brazil, 15015
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15025
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15090
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Sao Jose Do Rio Preto, Sao Paulo, Brazil, 15015
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Rio De Janeiro, Brazil, 20551
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Sao Paulo, Brazil, 05403
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Sao Paulo, Brazil, 04038
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Sao Paulo, Brazil, 040112-180
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Sao Paulo, Brazil, 04012
Canada, British Columbia
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New Westminster, British Columbia, Canada, V3L 3W4
Canada, Manitoba
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Winnipeg, Manitoba, Canada, R2V 4W3
Canada, Ontario
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Brampton, Ontario, Canada, L6W 2X7
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Burlington, Ontario, Canada, L7M 4Y1
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Cambridge, Ontario, Canada, N1R 6V6
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Cambridge, Ontario, Canada, N1R 7R1
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Grimsby, Ontario, Canada, L3M 1P3
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Hamilton, Ontario, Canada, L8M 1K7
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Hamilton, Ontario, Canada, L8L 2X2
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Oshawa, Ontario, Canada, L1H 1B9
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Oshawa,, Ontario, Canada, L1J 2J9
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Ottawa, Ontario, Canada, K1Y 4W7
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Sarnia, Ontario, Canada, N7T 4X3
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Sudbury, Ontario, Canada, P3C 5K7
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Sudbury, Ontario, Canada, P3E 2N8
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Toronto, Ontario, Canada, M4N 3M5
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Toronto, Ontario, Canada, M5B 1W8
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Weston, Ontario, Canada, M9N 1W4
Canada, Quebec
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Greenfield Park, Quebec, Canada, J4V 2G8
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Montreal, Quebec, Canada, H2W 1T8
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Montreal, Quebec, Canada, H2K 4L5
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Montreal, Quebec, Canada, H1T 1C8
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St. Georges Beauce, Quebec, Canada, G5Y 4W1
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St. Jerome, Quebec, Canada, J7Z 5T3
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St. Lambert, Quebec, Canada, J4P 2H4
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Terrebonne, Quebec, Canada, J6V 2H2
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Westmount, Quebec, Canada, H3Z 2M6
Canada, Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7L OY7
Canada
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Quebec, Canada, G1J 1Z6
Chile
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Temuco, Araucania, Chile, 4781173
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Victoria, Araucania, Chile, 4720000
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Osorno, Los Lagos, Chile
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Valdivia, Los Rios, Chile, 5111847
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Santiago, Metropolitana, Chile, 8330074
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Santiago, Metropolitana, Chile, 8360160
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Santiago, Metropolitana, Chile, 7500520
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Santiago, Metropolitana, Chile, 8900085
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Santiago, Metropolitana, Chile, 7600448
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Vina Del Mar, Valparaiso, Chile, 2570017
China, Beijing
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Beijing, Beijing, China, 100853
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Beijing, Beijing, China, 100088
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Beijing, Beijing, China, 100037
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Beijing, Beijing, China, 100038
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Beijing, Beijing, China, 100020
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Beijing, Beijing, China, 100029
China, Guangdong
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Guangzhou, Guangdong, China, 510180
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Shijiazhuang, Hebei, China, 050082
China, Hubei
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Wuhan, Hubei, China, 430060
China, Jiangsu
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Suzhou, Jiangsu, China, 215006
China, Liaoning
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Dalian, Liaoning, China, 116033
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Shenyang, Liaoning, China, 110001
China, Shandong
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Qingdao, Shandong, China, 266071
China, Shanghai
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Shanghai, Shanghai, China, 200025
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Shanghai, Shanghai, China, 200433
China, Sichuan
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Chengdu, Sichuan, China, 610041
Colombia
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Medellin, Antioquia, Colombia
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Barranquilla, Atlantico, Colombia
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Bucaramanga, Santander, Colombia
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Cali, Valle Del Cauca, Colombia
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Bogota, Colombia
Czech Republic
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Brno, Czech Republic, 656 91
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Havirov - Mesto, Czech Republic, 736 01
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Jindrichuv Hradec, Czech Republic, 377 38
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Kladno, Czech Republic, 272 59
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Kromeriz, Czech Republic, 767 55
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Mestec Kralove, Czech Republic, 289 03
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Ostrava, Czech Republic, 702 00
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Pisek, Czech Republic, 397 01
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Praha 1, Czech Republic, 110 00
Local Institution
Praha 2, Czech Republic, 128 08
Local Institution
Praha 5, Czech Republic, 150 00
Local Institution
Prelouc, Czech Republic, 535 01
Local Institution
Pribram, Czech Republic, 261 26
Local Institution
Slany, Czech Republic, 274 01
Local Institution
Usti Nad Orlici, Czech Republic, 562 18
Denmark
Local Institution
Arhus C, Denmark, 8000
Local Institution
Esbjerg, Denmark, 6700
Local Institution
Frederiksberg, Denmark, 2000
Finland
Local Institution
Espoo, Finland, 02740
Local Institution
Helsinki, Finland, 00029 HUS
Local Institution
Jyvaskyla, Finland, 40100
Local Institution
Kuopio, Finland, FI-70100
Local Institution
Tampere, Finland, 33900
France
Local Institution
Abbeville Cedex, France, 80142
Local Institution
Albi Cedex 09, France, 81013
Local Institution
Cholet, France, 49325
Local Institution
Grenoble Cedex 09, France, 38043
Local Institution
Langres Cedex, France, 52206
Local Institution
Paris Cedex 18, France, 75018
Local Institution
Sisteron, France, 04203
Local Institution
Toulon Cedex 09, France, 83041
Germany
Local Institution
Berlin, Germany, 13353
Local Institution
Berlin, Germany, 12099
Local Institution
Berlin, Germany, 10117
Local Institution
Bonn, Germany, 53115
Local Institution
Essen, Germany, 45147
Local Institution
Frankfurt Am Main, Germany, 60590
Local Institution
Halle/saale, Germany, 06097
Local Institution
Hamburg, Germany, 22299
Local Institution
Hamburg, Germany, 22527
Local Institution
Hamburg, Germany, 22291
Local Institution
Heidelberg, Germany, 69115
Local Institution
Heidelberg, Germany, 69120
Local Institution
Kassel, Germany, 34121
Local Institution
Koln, Germany, 51067
Local Institution
Leipzig, Germany, 04104
Local Institution
Magdeburg, Germany, 39112
Local Institution
Mainz, Germany, 55131
Local Institution
Mainz, Germany, 55116
Local Institution
Mannheim, Germany, 68167
Local Institution
Papenburg, Germany, 26871
Local Institution
Regensburg, Germany, 93053
Local Institution
Riesa, Germany, 01587
Local Institution
Witten, Germany, 58455
Local Institution
Wolmirstedt, Germany, 39326
Greece
Local Institution
Athens, Greece, 151 23
Local Institution
Larissa, Greece, 41 221
Local Institution
Thiva, Greece, 32200
Hong Kong
Local Institution
Shatin, New Territories, Hong Kong
Local Institution
Chai Wan, Hong Kong
Local Institution
Hong Kong, Hong Kong
India
Local Institution
Hyderabad, Andhra Pradesh, India, 500001
Local Institution
Bangalore, Karnataka, India, 560052
Local Institution
Banglore, Karnataka, India, 560054
Local Institution
Mysore, Karnataka, India, 570020
Local Institution
Mumbai, Maharashtra, India, 400007
Local Institution
Mumbai, Maharashtra, India, 400052
Local Institution
Nagpur,, Maharashtra, India, 440012
Local Institution
Nashik, Maharashtra, India, 422002
Local Institution
Pune, Maharashtra, India, 411001
Local Institution
Dhantoli, Nagpur, India, 440012
Local Institution
Chennai, Tamil Nadu, India, 600081
Local Institution
Lucknow, Uttar Pradesh, India, 226003
Local Institution
Ahmedabad, India, 380060
Local Institution
Bangalore, India, 560034
Local Institution
Bikaner, India, 334 003
Local Institution
Indore, India, 452001
Local Institution
Jaipur, India, 302001
Local Institution
Kottayam, India, 686016
Local Institution
Pune, India, 411030
Indonesia
Local Institution
Malang, Jawa-timur, Indonesia, 65111
Local Institution
Bandung, Indonesia, 40161
Local Institution
Denpasar, Indonesia, 80114
Local Institution
Jakarta, Indonesia, 10430
Local Institution
Jakarta, Indonesia, 13310
Local Institution
Jakarta Timur, Indonesia, 13750
Local Institution
Padang, Indonesia, 25137
Local Institution
Palembang, Indonesia, 30126
Local Institution
Surabaya, Indonesia, 60286
Local Institution
Yogyakarta, Indonesia, 55284
Israel
Local Institution
Afula, Israel, 18101
Local Institution
Ashkelon, Israel, 78278
Local Institution
Givatayim, Israel, 53583
Local Institution
Hadera, Israel, 38100
Local Institution
Haifa, Israel, 31096
Local Institution
Haifa, Israel, 34362
Local Institution
Holon, Israel, 58100
Local Institution
Nazareth, Israel, 16000
Local Institution
Nazareth, Israel, 16100
Local Institution
Petach-tikva, Israel, 49100
Local Institution
Safed, Israel, 13100
Local Institution
Tel Aviv, Israel, 64239
Italy
Local Institution
Ascoli Piceno, Italy, 63100
Local Institution
Chieti, Italy, 66013
Local Institution
Genova, Italy, 16132
Local Institution
Isernia, Italy, 86170
Local Institution
Lido Di Camaiore, Italy, 55043
Local Institution
Palermo, Italy, 90127
Local Institution
Perugia, Italy, 06126
Local Institution
San Daniele De Friuli (ud), Italy, 33038
Local Institution
Sassari, Italy, 07100
Korea, Republic of
Local Institution
Goyang-si, Gyeonggi-do, Korea, Republic of, 411-773
Local Institution
Seongnam-si, Gyeonggi-do, Korea, Republic of, 463-707
Local Institution
Kuri-city, Kyunggi-do, Korea, Republic of, 471-701
Local Institution
Busan, Korea, Republic of, 602-702
Local Institution
Daegu, Korea, Republic of, 700-721
Local Institution
Daejeon, Korea, Republic of, 302-718
Local Institution
Gwangju, Korea, Republic of, 501-757
Local Institution
Seoul, Korea, Republic of, 110-744
Local Institution
Seoul, Korea, Republic of, 130-709
Local Institution
Seoul, Korea, Republic of, 143-729
Malaysia
Local Institution
Johor Bahru, Johor, Malaysia, 80100
Local Institution
Cheras, Kuala Lumpur, Malaysia, 56000
Local Institution
Pulau Pinang, Pinang, Malaysia, 10990
Local Institution
Kuching, Sarawak, Malaysia, 93586
Local Institution
Kuala Lumpur, Malaysia, 50586
Local Institution
Kuala Lumpur, Malaysia, 59100
Mexico
Local Institution
Mexico, Distrito Federal, Mexico, 06726
Local Institution
Mexico, Distrito Federal, Mexico, 14080
Local Institution
Atizapan De Zaragoza, Estado De Mexico, Mexico, 52975
Local Institution
Acapulco, Guerrero, Mexico, 39570
Local Institution
Guadalajara, Jalisco, Mexico, 44670
Local Institution
Guadalajara, Jalisco, Mexico, 44600
Local Institution
Zapopan, Jalisco, Mexico, 45200
Local Institution
Monterrey, Nuevo Leon, Mexico, 64240
Local Institution
San Luis Potosi, Slp, San Luis Potosi, Mexico, 78240
Local Institution
Culiacan, Sinaloa, Mexico, 80020
Local Institution
Hermosillo, Sonora, Mexico, 83190
Local Institution
Jalapa, Veracruz, Mexico, 91020
Local Institution
Aguascalientes, Mexico, 20230
Local Institution
Aguascalientes, Mexico, 20127
Local Institution
Chihuahua, Mexico, 31203
Local Institution
Durango, Mexico, 34080
Local Institution
Queretaro, Mexico, 76000
Local Institution
San Luis Potosi, Mexico, 78200
Norway
Local Institution
Fyllingsdal, Norway, 5145
Local Institution
Kongsberg, Norway, 3602
Local Institution
Oslo, Norway, 0450
Local Institution
Oslo, Norway, 0264
Philippines
Local Institution
Naga City, Camarines Sur, Philippines, 4400
Local Institution
Binan, Laguna, Philippines, 4024
Local Institution
Iligan City, Lanao Del Norte, Philippines, 9200
Local Institution
Cagayan De Oro City, Philippines, 9000
Local Institution
Cavite, Philippines, 4114
Local Institution
Laoag City, Philippines, 2900
Local Institution
Manila, Philippines, 1000
Local Institution
Muntinlupa City, Philippines, 1780
Poland
Local Institution
Czestochowa, Poland, 42-200
Local Institution
Elblag, Poland, 82-300
Local Institution
Gdynia, Poland, 81-423
Local Institution
Gliwice, Poland, 44-100
Local Institution
Gniewkowo, Poland, 88-140
Local Institution
Grodzisk Mazowiecki, Poland, 05-825
Local Institution
Inowroclaw, Poland, 88-100
Local Institution
Kielce, Poland, 25-736
Local Institution
Krakow, Poland, 31-501
Local Institution
Krakow, Poland, 30-092
Local Institution
Lodz, Poland, 91-302
Local Institution
Piotrkow Trybunalski, Poland, 97-300
Local Institution
Plock, Poland, 09-402
Local Institution
Poznan, Poland, 60-539
Local Institution
Pulawy, Poland, 24-100
Local Institution
Siemianowice Slaskie, Poland, 41-100
Local Institution
Skierniewice, Poland, 96-100
Local Institution
Tarnow, Poland, 33-100
Local Institution
Warsaw, Poland, 00-217
Local Institution
Warszawa, Poland, 03-242
Local Institution
Warszawa, Poland, 04-073
Local Institution
Wegrow, Poland, 07-100
Local Institution
Zabrze, Poland, 41-800
Local Institution
Zarow, Poland, 58-130
Russian Federation
Local Institution
Kaluga, Anenki, Russian Federation, 248007
Local Institution
Barnaul, Russian Federation, 656055
Local Institution
Chelyabinsk, Russian Federation, 454136
Local Institution
Ekaterinburg, Russian Federation, 620109
Local Institution
Ekaterinburg, Russian Federation, 620144
Local Institution
Kazan, Russian Federation, 420012
Local Institution
Kemerovo, Russian Federation, 650002
Local Institution
Krasnodar, Russian Federation, 350042
Local Institution
Moscow, Russian Federation, 105066
Local Institution
Moscow, Russian Federation, 125284
Local Institution
Moscow, Russian Federation, 129336
Local Institution
Moscow, Russian Federation, 119121
Local Institution
Moscow, Russian Federation, 109240
Local Institution
Moscow, Russian Federation, 121356
Local Institution
Moscow, Russian Federation, 127644
Local Institution
Moscow, Russian Federation, 101990
Local Institution
Moscow, Russian Federation, 125367
Local Institution
Moscow, Russian Federation, 117485
Local Institution
Moscow, Russian Federation, 129301
Local Institution
Moscow, Russian Federation, 143000
Local Institution
Moscow, Russian Federation, 111539
Local Institution
Moscow, Russian Federation, 121552
Local Institution
Nizhniy Novgorod, Russian Federation, 603035
Local Institution
Novosibirsk, Russian Federation, 630047
Local Institution
Perm, Russian Federation, 614107
Local Institution
Perm, Russian Federation, 614097
Local Institution
Ryazan, Russian Federation, 390026
Local Institution
Saint Petersburg, Russian Federation, 193079
Local Institution
Saint-petersburg, Russian Federation, 194291
Local Institution
Saint-petersburg, Russian Federation, 190000
Local Institution
Saint-petersburg, Russian Federation, 191025
Local Institution
Saint-petersburg, Russian Federation, 194156
Local Institution
Saint-petersburg, Russian Federation, 193144
Local Institution
Samara, Russian Federation, 443095
Local Institution
Samara, Russian Federation, 443070
Local Institution
Saratov, Russian Federation, 410054
Local Institution
Saratov, Russian Federation, 410028
Local Institution
St.petersburg, Russian Federation, 197198
Local Institution
St.petersburg, Russian Federation, 195112
Local Institution
Tomsk, Russian Federation, 634012
Local Institution
Tumen, Russian Federation, 625023
Local Institution
Tver, Russian Federation, 170036
Local Institution
Yaroslavl, Russian Federation, 150062
Singapore
Local Institution
Singapore, Singapore, 169609
Local Institution
Singapore, Singapore, 768828
Local Institution
Singapore, Singapore, 308433
Local Institution
Singapore, Singapore, 529889
South Africa
Local Institution
Bloemfontein, Free State, South Africa, 9300
Local Institution
Bloemfontein, Free State, South Africa, 9301
Local Institution
Alberton, Gauteng, South Africa, 1450
Local Institution
Bellville, Cape Town, Western Cape, South Africa, 7530
Local Institution
Cape Town, Western Cape, South Africa, 7925
Local Institution
Somerset West, Western Cape, South Africa, 7130
Local Institution
Worcester, Western Cape, South Africa, 6850
Local Institution
Pretoria, South Africa, 0041
Spain
Local Institution
Torrevieja, Alicante, Spain, 03186
Local Institution
Hospitalet De Llobregat, Barcelona, Spain, 08907
Local Institution
Lugo, Galicia, Spain, 27003
Local Institution
Albacete, Spain, 02006
Local Institution
Madrid, Spain, 28007
Local Institution
Madrid, Spain, 28034
Local Institution
Valencia, Spain, 46017
Sweden
Local Institution
Goteborg, Sweden, 416 85
Local Institution
Goteborg, Sweden, 417 17
Local Institution
Molndal, Sweden, 431 80
Local Institution
Stockholm, Sweden, 111 57
Local Institution
Stockholm, Sweden, 118 83
Local Institution
Stockholm, Sweden, 141 86
Local Institution
Uppsala, Sweden, 751 85
Taiwan
Local Institution
Kaohsiung, Taiwan, 807
Local Institution
Taichung, Taiwan, 402
Local Institution
Tainan, Taiwan, 704
Local Institution
Taipei, Taiwan, 111
Local Institution
Taipei, Taiwan, 10507
Local Institution
Taipei, Taiwan, 220
Turkey
Local Institution
Isparta, Turkey, 32100
Local Institution
Istanbul, Turkey, 34390
Local Institution
Istanbul, Turkey, 34304
Local Institution
Kirikkale, Turkey, 71100
Ukraine
Local Institution
Dnipropetrovsk, Ukraine, 49005
Local Institution
Donetsk, Ukraine, 83114
Local Institution
Kharkiv, Ukraine, 61115
Local Institution
Kharkiv, Ukraine, 61002
Local Institution
Kharkiv, Ukraine, 61176
Local Institution
Kharkiv, Ukraine, 61029
Local Institution
Kharkiv, Ukraine, 61018
Local Institution
Kyiv, Ukraine, 04114
Local Institution
Kyiv, Ukraine, 02091
Local Institution
Kyiv, Ukraine, 04107
Local Institution
Kyiv, Ukraine, 01023
Local Institution
Kyiv, Ukraine, 03680
Local Institution
Kyiv, Ukraine, 02660
United Kingdom
Local Institution
Aberdeen, Aberdeenshire, United Kingdom, AB25 2ZN
Local Institution
Chesterfield, Derbyshire, United Kingdom, S44 5BL
Local Institution
Basildon, Essex, United Kingdom, SS16 5NL
Local Institution
Romford, Essex, United Kingdom, RM7 0AG
Local Institution
Kirkcaldy, Fife, United Kingdom, KY2 5AH
Local Institution
London, Greater London, United Kingdom, SW17 ORE
Local Institution
Glasgow, Lanarkshire, United Kingdom, G11 6NT
Local Institution
Glasgow, Lanarkshire, United Kingdom, G51 4TF
Local Institution
Blackpool, Lancashire, United Kingdom, FY3 8NR
Local Institution
Northampton, Northamptonshire, United Kingdom, NN1 5BD
Local Institution
Worksop, Nottinghamshire, United Kingdom, S18 0BD
Local Institution
Craigavon, Portadown, United Kingdom, BT63 5QQ
Local Institution
Paisley, Renfrewshire, United Kingdom, PA2 9PN
Local Institution
Barnsley, South Yorkshire, United Kingdom, S75 2EP
Local Institution
Larbert, Stirlingshire, United Kingdom, FK5 4WR
Local Institution
Newcastle Upon, Tyne And Wear, United Kingdom, NE2 4HH
Local Institution
Birmingham, West Midlands, United Kingdom, B18 7QH
Local Institution
Chichester, West Sussex, United Kingdom, PO19 6SE
Sponsors and Collaborators
Bristol-Myers Squibb
Pfizer
Investigators
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
  More Information

Additional Information:
No publications provided by Bristol-Myers Squibb

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT00496769     History of Changes
Other Study ID Numbers: CV185-048
Study First Received: July 2, 2007
Results First Received: August 1, 2013
Last Updated: July 8, 2014
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
Chile: Instituto de Salud Pública de Chile
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Mexico: Federal Commission for Sanitary Risks Protection
Austria: Agency for Health and Food Safety
Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment
Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
France: Ministry of Health
Germany: Ministry of Health
Greece: National Organization of Medicines
Israel: Ministry of Health
Italy: Ministry of Health
Norway: Ministry of Health and Social Affairs
Spain: Spanish Agency of Medicines
South Africa: Department of Health
Sweden: The National Board of Health and Welfare
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Czech Republic: Ministry of Health
Poland: Ministry of Health
Russia: Ministry of Health of the Russian Federation
Ukraine: Ministry of Health
Australia: Department of Health and Ageing Therapeutic Goods Administration
China: National Institute for the Control of Pharmaceutical and Biological Products
Hong Kong: Department of Health
India: Central Drugs Standard Control Organization
Indonesia: Ministry of Health
Korea: Food and Drug Administration
Malaysia: National Pharmaceutical Control Bureau
Philippines: Department of Health
Singapore: Ministry of Health
Taiwan: Department of Health

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Aspirin
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Central Nervous System Agents

ClinicalTrials.gov processed this record on July 29, 2014