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NCT00249873 · ClinicalTrials.gov registry record · Phase 3
Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)
A Phase 3 study of Atrial Fibrillation and Vascular Risk, sponsored by Sanofi.
- Completed
- Registry status
- Phase 3
- Development phase
- 7,554
- Enrollment target
- 20
- Study locations
NCT00249873: Completed Phase 3 study of Atrial Fibrillation and Vascular Risk, sponsored by Sanofi.
NCT00249873 is a Phase 3 study of Atrial Fibrillation and Vascular Risk that has completed, run by Sanofi. The registered enrollment target is 7,554 participants, above the 2,960-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (155% higher). The trial reports 20 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00249873, a Phase 3 study of Atrial Fibrillation and Vascular Risk, has completed, sponsored by Sanofi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 7,554 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
The primary event is the first occurence of any adjudicated component of the following cluster over the duration of follow-up : * stroke (nonfatal or fatal) * myocardial infarction (nonfatal or fatal) * non-CNS systemic embolism * vascular death 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.
Conditions Studied
Interventions
- DRUG placebo
- DRUG clopidogrel (SR25990C)
Study Locations (20)
Other
- Sanofi-Aventis Administrative Office - Buenos Aires
- Sanofi-Aventis Administrative Office - Macquarie Park
- Sanofi-Aventis - Vienna
- Sanofi-aventis Administrative Office - Diegem
- Sanofi-Aventis Administrative Office - São Paulo
- Sanofi-Aventis Administrative Office - Laval
- Sanofi-Aventis Administrative Office - Santiago
- Sanofi-Aventis Administrative Office - Prague
- Sanofi-Aventis Administrative Office - Hørsholm
- Sanofi-Aventis Administrative Office - Helsinki
- Sanofi-Aventis Administrative Office - Paris
- Sanofi-Aventis Administrative Office - Berlin
- Sanofi-Aventis Administrative Office - Athens
- Sanofi-Aventis Administrative Office - Causeway Bay
- Sanofi-Aventis Administrative Office - Budapest
- Sanofi-Aventis Administrative Office - Milan
- Sanofi-Aventis Administrative Office - Kuala Lumpur
- Sanofi-Aventis Administrative Office - México
- Sanofi-Aventis Administrative Office - Gouda
New Jersey
- Sanofi-Aventis Administrative Office - Bridgewater
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 7,554 participants |
| Start Date | 2003-06 |
| Est. Completion | 2009-03 |
| Phase | Phase 3 |
What the finished NCT00249873 record still lists
NCT00249873 is an interventional study that assigns participants to a tested intervention. Its 7,554 participants enrollment target places it among the larger protocols in the corpus, above the 2,960-participant average among 202 other Atrial Fibrillation trials with a reported enrollment target (155% higher).
The record links to 2 conditions, with Atrial Fibrillation appearing as the primary indexed condition, and to 2 interventions - of which placebo is the first listed.
NCT00249873 names 20 study sites across 2 states, led by Other, New Jersey.
Frequently Asked Questions
What is clinical trial NCT00249873 about?
NCT00249873 is a clinical study titled "Atrial Fibrillation Clopidogrel Trial With Irbesartan for Prevention of Vascular Events (ACTIVE A)". 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 ...
What is the current status of trial NCT00249873?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 7,554 participants. The study started on 2003-06. Estimated completion is 2009-03.
What conditions does trial NCT00249873 study?
This clinical trial studies the following conditions: Atrial Fibrillation, Vascular Risk.
What interventions are being tested in trial NCT00249873?
The interventions under investigation include: placebo (DRUG), clopidogrel (SR25990C) (DRUG).
Who is sponsoring clinical trial NCT00249873?
This trial is sponsored by Sanofi, which has 713 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00249873 being conducted?
This trial has 20 study locations across New Jersey. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00249873's enrollment target sits among peer trials
7,554 15th of 202 higher than 188 of 202 other Atrial Fibrillation trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atrial Fibrillation trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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