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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 Nonvalvula

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Trial Conditions
  • Atrial Fibrillation
  • Atrial Flutter
What is the purpose of this trial?

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.

Date & Status

Completed

Who can Participate?

Eligibility

Ages:
18 and older

Gender:
Both

Eligibility

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

Gender: Both
Steward Physician(s)
  • Bristol-Myers Squibb
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • warfarin
  • apixaban
Physician Researcher

Investigator Name:

  • Bristol-Myers Squibb

Other Information

Sponsor: Bristol-Myers Squibb
Phase: Phase 3
Trial ID: NCT00412984
Volunteers:  Not Accepting Healthy Volunteers

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