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| Sponsor: | Sanofi-Aventis |
|---|---|
| Collaborator: |
Bristol-Myers Squibb |
| Information provided by: | Sanofi-Aventis |
| ClinicalTrials.gov Identifier: | NCT00249795 |
Purpose
The purpose of this study is to determine if irbesartan 300mg once daily (od) compared to placebo tablet (an inert substance) will reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death during approximately 3 years of follow-up in patients with atrial fibrillation and with a systolic blood pressure of at least 110 mmHg associated with at least one major risk of vascular events because they are already enrolled into ACTIVE A or ACTIVE W study.
| Condition | Intervention | Phase |
|---|---|---|
|
Atrial Fibrillation Cardiovascular Disease |
Drug: Irbesartan Drug: placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial 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: | 9000 |
| Study Start Date: | June 2003 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Irbesartan
oral administration of 300mg once daily
|
| 2: Placebo Comparator |
Drug: placebo
oral administration once daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Should fulfill first the eligibility criteria for Active A or Active W study and :
Exclusion Criteria:
Patients will be excluded from ACTIVE if any of the following are present:
Contacts and Locations
Show 30 Study Locations| Study Chair: | Salim YUSUF, Prof. | Hamilton Health Sciences Corporation |
More Information
| Responsible Party: | Sanofi-aventis ( ICD Study Director ) |
| Study ID Numbers: | EFC4912 I, SR25990C |
| Study First Received: | November 4, 2005 |
| Last Updated: | October 20, 2009 |
| ClinicalTrials.gov Identifier: | NCT00249795 History of Changes |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial fibrillation Cardivascular disease angiotensin II blocker |
|
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 |