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Sponsors and Collaborators: |
Bristol-Myers Squibb Pfizer |
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Information provided by: | Bristol-Myers Squibb |
ClinicalTrials.gov Identifier: | NCT00496769 |
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.
Condition | Intervention | Phase |
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Atrial Fibrillation |
Drug: Apixaban Drug: Acetylsalicylic Acid (ASA) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 5600 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | April 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental |
Drug: Apixaban
Tablets, Oral, 5 mg (2.5 mg in selected patients), BID, Up to 36 months/End of Study
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II: Placebo Comparator |
Drug: Acetylsalicylic Acid (ASA)
Tablets, Oral, 81 - 324 mg, QD, Up to 36 months/End of Study
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Ages Eligible for Study: | 50 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Presence of at least one of the following risk factors for stroke:
The patient is not currently receiving vitamin K antagonist therapy for one of the following reasons:
Exclusion Criteria:
Patient with serious bleeding in the last 6 months or at high risk of bleeding. This includes, but is not limited to:
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: | CV185-048 |
Study First Received: | July 2, 2007 |
Last Updated: | May 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00496769 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Brazil: National Health Surveillance Agency; Chile: Instituto de Salud Publica de Chile; Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos; Mexico: Federal Commission for Sanitary Risks Protection; Austria: Agency for Health and Food Safety; Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment; Denmark: Danish Medicines Agency; Finland: National Agency for Medicines; France: Ministry of Health; Germany: Ministry of Health; Greece: National Organization of Medicines; Israel: Ministry of Health; Italy: Ministry of Health; Norway: Ministry of Health and Social Affairs; Spain: Spanish Agency of Medicines; South Africa: Department of Health; Sweden: The National Board of Health and Welfare; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Czech Republic: Ministry of Health; Poland: Ministry of Health; Russia: Ministry of Health and Social Development of the Russian Federation; Ukraine: Ministry of Health; Australia: Department of Health and Ageing Therapeutic Goods Administration; China: National Institute for the Control of Pharmaceutical and Biological Products; Hong Kong: Department of Health; India: Central Drugs Standard Control Organization; Indonesia: Ministry of Health; Korea: Food and Drug Administration; Malaysia: National Pharmaceutical Control Bureau; Philippines: Department of Health; Singapore: Ministry of Health; Taiwan: Department of Health |
Anti-Inflammatory Agents Heart Diseases Cerebral Infarction Cyclooxygenase Inhibitors Stroke Fibrinolytic Agents Cardiovascular Agents Fibrin Modulating Agents Aspirin Analgesics, Non-Narcotic |
Vitamins Vitamin K Platelet Aggregation Inhibitors Anti-Inflammatory Agents, Non-Steroidal Atrial Fibrillation Analgesics Peripheral Nervous System Agents Antirheumatic Agents Arrhythmias, Cardiac |
Anti-Inflammatory Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Hematologic Agents Fibrinolytic Agents Fibrin Modulating Agents Pathologic Processes Aspirin Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Cardiovascular Diseases Analgesics |
Heart Diseases Cyclooxygenase Inhibitors Enzyme Inhibitors Cardiovascular Agents Pharmacologic Actions Analgesics, Non-Narcotic Platelet Aggregation Inhibitors Peripheral Nervous System Agents Atrial Fibrillation Antirheumatic Agents Central Nervous System Agents Arrhythmias, Cardiac |