At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 9,016 enrolled
Drug / intervention
Irbesartan +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.
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
In Brief
A Phase 3 clinical trial evaluating Irbesartan and placebo for Atrial Fibrillation and Cardiovascular Disease. Completed, enrolled 9,016 participants across 30 sites in 30 countries.
Detailed Summary
The purpose of this study was to determine if Irbesartan compared to Placebo would reduce the risk of vascular events such as heart attack, stroke, non-cerebral thromboembolic event and death in patients with Atrial Fibrillation (AF) and with at least one major risk of vascular events.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Cardiovascular Disease
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
Enrollment StartJun 2003
First PostedNov 2005
Primary CompletionAug 2009
TodayJul 2026
First PostedNov 7, 2005
Enrollment StartJun 1, 2003
Primary CompletionAug 1, 2009
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 20.7 years ago
Interventions
Irbesartandrug
oral administration (tablets) once daily
placebodrug
oral administration (tablets) once daily