NCT00412984
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
PHASE3
COMPLETED
NCT00412984
INTERVENTIONAL
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
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.
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
Atrial Fibrillation
Atrial Flutter
- PREVENTION
-
- Type: DRUG
- Name: warfarin
- Description: Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
- Arm Group Labels: 1
-
- Type: DRUG
- Name: apixaban
- Description: Oral tablets, 5.0 mg or 2.5 mg, twice daily
- Arm Group Labels: 2
- Bristol-Myers Squibb