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NCT00243178 · ClinicalTrials.gov registry record · Phase 3
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)
A Phase 3 study, sponsored by Sanofi.
- Terminated
- Registry status
- Phase 3
- Development phase
- 6,706
- Enrollment target
NCT00243178 is a Phase 3 study that was terminated before completion, run by Sanofi. The registered enrollment target is 6,706 participants.
The verdict
NCT00243178, a Phase 3 study, was terminated before completion, sponsored by Sanofi.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 6,706 participants
- Enrollment target
Study 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 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.
Interventions
- DRUG clopidogrel (SR25990C)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,706 participants |
| Start Date | 2003-07 |
| Est. Completion | 2005-09 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00243178
The ClinicalTrials.gov registry entry for NCT00243178 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 6,706 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Sanofi, which has 713 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which clopidogrel (SR25990C) is the first listed.
NCT00243178 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00243178 about?
NCT00243178 is a clinical study titled "Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE W)". 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 cardio...
What is the current status of trial NCT00243178?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 6,706 participants. The study started on 2003-07. Estimated completion is 2005-09.
What interventions are being tested in trial NCT00243178?
The interventions under investigation include: clopidogrel (SR25990C) (DRUG).
Who is sponsoring clinical trial NCT00243178?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
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