Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00243178
Status:
TERMINATED
Last Update Posted:
2009-10-19
First Post:
2005-10-20
Brief Title:
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events ACTIVE W
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2009-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 factorPrimary objectives The combination of clopidogrel plus aspirin compared to adjusted dose INR between 20 and 33 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 fibrillationThe secondary objective is to establish whether or not aspirin plus clopidogrel has a lower risk of hemorrhage than standard anticoagulation therapy
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None