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Sponsors and Collaborators: |
Sanofi-Aventis Bristol-Myers Squibb |
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Information provided by: | Sanofi-Aventis |
ClinicalTrials.gov Identifier: | NCT00243178 |
The purpose of this study is to determine if the combination of Clopidogrel 75mg once daily (od) plus aspirin at 100mg daily (recommended dose) is as effective as oral anticoagulation therapy with a lower risk of bleeding in patients with atrial fibrillation associated with at least one major cardiovascular risk factor.Primary objectives :The combination of clopidogrel plus aspirin compared to adjusted dose (INR between 2.0 and 3.3) oral anticoagulation (a vitamin K antagonist) will result in the same risk of the composite outcome of stroke, non-CNS systemic embolism, myocardial infarction or vascular death in patients with atrial fibrillation.The secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy.
Condition | Intervention | Phase |
---|---|---|
Atrial Fibrillation Vascular Risk |
Drug: clopidogrel (SR25990C) |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study |
Official Title: | A Parallel Randomized Controlled Evaluation of Clopidogrel Plus Aspirin, With Factorial Evaluation of Irbesartan, for the Prevention of Vascular Events, in Patients With Atrial Fibrillation |
Estimated Enrollment: | 6500 |
Study Start Date: | July 2003 |
Estimated Study Completion Date: | November 2005 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Evidence of high risk of vascular events: at least one of the following risk criteria must be present:
Exclusion Criteria:
Patients will be excluded from ACTIVE if any of the following are present :
Study Chair: | Salim YUSUF, Prof. | Hamilton Health Sciences Corporation |
Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
Study ID Numbers: | EFC4912 W, SR25990C |
Study First Received: | October 20, 2005 |
Last Updated: | September 25, 2008 |
ClinicalTrials.gov Identifier: | NCT00243178 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Atrial fibrillation Anticoagulant therapy Thromboembolic prevention |
Anticoagulants Heart Diseases Aspirin Clopidogrel |
Irbesartan Platelet Aggregation Inhibitors Atrial Fibrillation Arrhythmias, Cardiac |
Pathologic Processes Heart Diseases Therapeutic Uses Clopidogrel Hematologic Agents |
Platelet Aggregation Inhibitors Cardiovascular Diseases Atrial Fibrillation Pharmacologic Actions Arrhythmias, Cardiac |