Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE)


Tracking Information

Start Date  ICMJEDecember 2006
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2008)		confirmed stroke or systemic embolism [ Time Frame: Time to first occurrence ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ICMJE 
 (submitted: December 18, 2006)		Time to first occurrence of confirmed stroke or systemic embolism
Change HistoryComplete list of historical versions of study NCT00412984 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE 
 (submitted: August 14, 2008)		confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death [ Time Frame: Time to first occurrence ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ICMJE 
 (submitted: December 18, 2006)		Time to first occurrence of confirmed ischemic stroke, hemorrhagic stroke, systemic embolism, all cause death

Descriptive Information

Brief Title  ICMJEApixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
Official Title  ICMJEA 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
Brief Summary

The trial seeks to determine if apixaban, an investigational anticoagulant (blood-thinner) is as effective as standard therapy (warfarin) in preventing stroke and systemic embolism in subjects with atrial fibrillation and risk factors for stroke.

Detailed Description 
Study PhasePhase III
Study Type  ICMJEInterventional
Study Design  ICMJEPrevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study
Condition  ICMJE
  • Atrial Fibrillation
  • Atrial Flutter
Intervention  ICMJE
  • Drug: warfarin
    Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
    Other Names:
    • Coumadin
    • BMS-565793
  • Drug: apixaban
    Oral tablets, 5.0 mg, twice daily
    Other Name: BMS-562247
Study Arms / Comparison Groups
  • 1: Active Comparator
    Intervention: Drug: warfarin
  • 2: Experimental
    Intervention: Drug: apixaban

Recruitment Information

Estimated Enrollment  ICMJE18183
Estimated Completion DateApril 2011
Estimated Primary Completion DateApril 2011   (final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Males and females ≥ 18 yrs with AF and one or more of the following risk factors for stroke:
  • Age ≥ 75, previous stroke
  • TIA or Systemic Embolism
  • Symptomatic congestive heart failure or left ventricular dysfunction with LVEF ≤ 40%
  • Diabetes mellitus or hypertension requiring pharmacological treatment
GenderBoth
Ages18 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: For participation information at a USA site use a phone number below. For site information outside the USA please email:Clinical.Trials@bms.com
Contact: First line of email MUST contain NCT# & Site#. Only trial sites that are recruiting have contact information at this time.
Location Countries  ICMJEUnited States,   Argentina,   Australia,   Austria,   Belgium,   Brazil,   Canada,   Chile,   China,   Colombia,   Czech Republic,   Denmark,   Finland,   France,   Germany,   Hong Kong,   Hungary,   India,   Israel,   Italy,   Japan,   Korea, Republic of,   Malaysia,   Mexico,   Netherlands,   Norway,   Peru,   Philippines,   Poland,   Puerto Rico,   Romania,   Russian Federation,   Singapore,   South Africa,   Spain,   Sweden,   Taiwan,   Turkey,   Ukraine,   United Kingdom

Administrative Information

NCT ID  ICMJENCT00412984
Responsible PartyStudy Director, Bristol-Myers Squibb
Study ID Numbers  ICMJECV185-030
Study Sponsor  ICMJEBristol-Myers Squibb
Collaborators  ICMJE 
Investigators  ICMJE
Study Director:Bristol-Myers SquibbBristol-Myers Squibb
Information Provided ByBristol-Myers Squibb