Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation (ARISTOTLE)
Tracking Information
Start Date ICMJE | December 2006 |
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Estimated Primary Completion Date | April 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 History | Complete 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 ICMJE | Apixaban for the Prevention of Stroke in Subjects With Atrial Fibrillation |
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Official Title ICMJE | 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 |
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 Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Efficacy Study |
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Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 18183 | ||||||||
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Estimated Completion Date | April 2011 | ||||||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts ICMJE |
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Location Countries ICMJE | United 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 ICMJE | NCT00412984 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CV185-030 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
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Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/