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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00249873 |
Purpose
The purpose of this study is to determine if the combination of clopidogrel 75mg once daily (od) plus aspirin 100mg daily (recommended dose) is better than aspirin alone (100mg daily recommended dose) for preventing vascular events such as stroke and heart attack during approximately three years of follow-up in patients with atrial fibrillation associated with at least one major risk factor of vascular event such as elderly, blood pressure increase, history of stroke or transient ischemic attack or left ventricular dysfunction etc. The study will also accept patients with atrial fibrillation and unwilling to take oral anticoagulant therapy.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Vascular Risk |
Drug: clopidogrel (SR25990C) Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo 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 |
| Enrollment: | 7554 |
| Study Start Date: | June 2003 |
| Study Completion Date: | November 2008 |
| Primary Completion Date: | November 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: clopidogrel (SR25990C)
75 mg once daily in combination with aspirin
|
| 2: Placebo Comparator |
Drug: placebo
in combination with aspirin
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
To be eligible for ACTIVE A patients must have in same time the three following conditions :
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 :
Contacts and Locations
Show 30 Study Locations| Study Chair: | Philippe YUSUF, Prof. | Hamilton Health Sciences Corporation |
More Information
| Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC4912 A |
| Study First Received: | November 4, 2005 |
| Last Updated: | April 6, 2009 |
| ClinicalTrials.gov Identifier: | NCT00249873 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial fibrillation Anticoagulant therapy Thromboembolic prevention |
|
Heart Diseases Molecular Mechanisms of Pharmacological Action Hematologic Agents Irbesartan Cardiovascular Agents Antihypertensive Agents Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers |
Pathologic Processes Clopidogrel Therapeutic Uses Cardiovascular Diseases Platelet Aggregation Inhibitors Atrial Fibrillation Arrhythmias, Cardiac |