Trials / Completed
CompletedNCT00412984
Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 20,976 (actual)
- Sponsor
- Bristol-Myers Squibb · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | warfarin | Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0) |
| DRUG | apixaban | Oral tablets, 5.0 mg or 2.5 mg, twice daily |
Timeline
- Start date
- 2006-12-31
- Primary completion
- 2011-05-25
- Completion
- 2011-05-25
- First posted
- 2006-12-19
- Last updated
- 2018-07-03
- Results posted
- 2013-04-29
Locations
1,111 sites across 41 countries: United States, Argentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Colombia, Czechia, Denmark, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Peru, Philippines, Poland, Puerto Rico, Romania, Russia, Singapore, South Africa, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey (Türkiye), Ukraine, United Kingdom
Source: ClinicalTrials.gov record NCT00412984. Inclusion in this directory is not an endorsement.