CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 7,554 enrolled
Drug / intervention
clopidogrel (SR25990C) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00249873
NCT00249873Phase 3Completed
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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

Sanofi·interventional·Posted Nov 7, 2005·Updated Jun 15, 2015

In Brief

A Phase 3 clinical trial evaluating clopidogrel (SR25990C) and placebo for Atrial Fibrillation and Vascular Risk. Completed, enrolled 7,554 participants across 30 sites in 30 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Vascular Risk
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, Czechia, Denmark, Finland, France, Germany, Greece, Hong Kong, Hungary, Italy, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Singapore, South Africa, Spain, Sweden, Switzerland, Taiwan, United Kingdom, United States
CollaboratorsBristol-Myers Squibb

Timeline

Phase 3CompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 7, 2005
Enrollment StartJun 1, 2003
Primary CompletionMar 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5.8 yearsPosted 20.7 years ago

Interventions

clopidogrel (SR25990C)drug

oral administration (tablets)

placebodrug

oral administration (tablets)