A Phase III Study of Apixaban in Patients With Atrial Fibrillation (AVERROES)
Tracking Information
Start Date ICMJE | September 2007 |
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Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) |
Current Primary Outcome Measures ICMJE (submitted: April 17, 2009) | The primary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted ischemic stroke, hemorrhagic stroke or systemic embolism [ Time Frame: Time to first occurrence ] [ Designated as safety issue: No ] |
Original Primary Outcome Measures ICMJE (submitted: July 2, 2007) | To determine if apixaban 5 mg BID (2.5 mg BID in selected patients) is superior to ASA (81 to 324 mg QD) for preventing the composite outcome of stroke or systemic embolism in patients with atrial fibrillation and at least one additional risk factor [ Time Frame: Time to first occurrence ] |
Change History | Complete list of historical versions of study NCT00496769 on ClinicalTrials.gov Archive Site |
Current Secondary Outcome Measures ICMJE (submitted: April 17, 2009) | The secondary efficacy outcome will be the time (days) from first dose of study drug to first occurrence of unrefuted Ischemic stroke, hemorrhagic stroke, systemic embolism, myocardial infarction, or vascular death [ Time Frame: Time to first occurrence ] [ Designated as safety issue: No ] |
Original Secondary Outcome Measures ICMJE (submitted: July 2, 2007) | To determine, in the same patients, if apixaban is superior to ASA for prevention of the composite outcome of: Stroke, systemic embolism, myocardial infarction or vascular death (major vascular events) [ Time Frame: Time to first occurrence ] |
Descriptive Information
Brief Title ICMJE | A Phase III Study of Apixaban in Patients With Atrial Fibrillation |
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Official Title ICMJE | Apixaban Versus Acetylsalicylic Acid (ASA) to Prevent Stroke in Atrial Fibrillation Patients Who Have Failed or Are Unsuitable for Vitamin K Antagonist Treatment: A Randomized Double Blind Trial |
Brief Summary | The purpose of this clinical research study is to learn if apixaban is more effective than Acetylsalicylic Acid (ASA) in preventing strokes associated with subjects who have atrial fibrillation. The safety of this treatment will also be studied. |
Detailed Description | |
Study Phase | Phase III |
Study Type ICMJE | Interventional |
Study Design ICMJE | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Condition ICMJE | Atrial Fibrillation |
Intervention ICMJE |
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Study Arms / Comparison Groups |
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Recruitment Information
Estimated Enrollment ICMJE | 5600 | ||||||||
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Estimated Completion Date | August 2010 | ||||||||
Estimated Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||||||
Ages | 50 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, Greece, Hong Kong, India, Indonesia, Israel, Italy, Korea, Republic of, Malaysia, Mexico, Norway, Philippines, Poland, Russian Federation, Singapore, South Africa, Spain, Sweden, Taiwan, Turkey, Ukraine, United Kingdom |
Administrative Information
NCT ID ICMJE | NCT00496769 | ||||
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Responsible Party | Study Director, Bristol-Myers Squibb | ||||
Study ID Numbers ICMJE | CV185-048 | ||||
Study Sponsor ICMJE | Bristol-Myers Squibb | ||||
Collaborators ICMJE | Pfizer | ||||
Investigators ICMJE |
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Information Provided By | Bristol-Myers Squibb |
Source: http://clinicaltrials.gov/