|
Home
Search
Study Topics
Glossary
|
![]() |
![]() |
|
![]() |
|
![]() |
|
![]() |
![]() |
![]() |
|
![]() |
![]() |
||||||||||||||||||||||||||||||||||||
| 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: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Prevention |
| 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 |
The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up :
The primary efficacy analysis is performed on the time from randomization to this primary event. Numbers of patients with the composite event over the duration of the follow-up are presented by arm group.
| Enrollment: | 7554 |
| Study Start Date: | June 2003 |
| Study Completion Date: | March 2009 |
| Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Clopidogrel + ASA
Clopidogrel 75 mg once daily (od) plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
|
Drug: clopidogrel (SR25990C)
oral administration (tablets)
Other Name: Plavix®
|
|
Placebo Comparator: Placebo + ASA
Matching placebo of clopidogrel 75 mg od plus acetylsalicyclic acid (ASA) 75 to 100 mg od recommended (dose at the investigators' discretion)
|
Drug: placebo
oral administration (tablets)
|
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: | International Clinical Development Study Director, Sanofi-aventis |
| ClinicalTrials.gov Identifier: | NCT00249873 History of Changes |
| Other Study ID Numbers: | EFC4912 A |
| Study First Received: | November 4, 2005 |
| Results First Received: | March 8, 2010 |
| Last Updated: | March 31, 2010 |
| Health Authority: | United States: Food and Drug Administration |
|
Atrial fibrillation Anticoagulant therapy Thromboembolic prevention |
|
Atrial Fibrillation Arrhythmias, Cardiac Heart Diseases Cardiovascular Diseases Pathologic Processes Clopidogrel Ticlopidine Irbesartan Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Purinergic P2Y Receptor Antagonists |
Purinergic P2 Receptor Antagonists Purinergic Antagonists Purinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Fibrinolytic Agents Fibrin Modulating Agents Cardiovascular Agents Antihypertensive Agents Angiotensin II Type 1 Receptor Blockers Angiotensin Receptor Antagonists |