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Sponsored by: |
Bristol-Myers Squibb |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00412984 |
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.
Condition | Intervention | Phase |
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Atrial Fibrillation Atrial Flutter |
Drug: warfarin Drug: apixaban |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 15000 |
Study Start Date: | December 2006 |
Estimated Study Completion Date: | November 2010 |
Estimated Primary Completion Date: | November 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator |
Drug: warfarin
Oral tablets, 2.0 mg, adjusted to an INR of 2.5 (range 2.0 to 3.0)
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2: Experimental |
Drug: apixaban
Oral tablets, 5.0 mg, twice daily
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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. |
Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Responsible Party: | Bristol-Myers Squibb ( Study Director ) |
Study ID Numbers: | CV185-030 |
Study First Received: | December 18, 2006 |
Last Updated: | January 12, 2009 |
ClinicalTrials.gov Identifier: | NCT00412984 |
Health Authority: | United States: Food and Drug Administration |
Heart Diseases Cerebral Infarction Embolism Stroke |
Warfarin Atrial Fibrillation Atrial Flutter Arrhythmias, Cardiac |
Anticoagulants Pathologic Processes Therapeutic Uses |
Hematologic Agents Cardiovascular Diseases Pharmacologic Actions |