At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 15,526 enrolled
Drug / intervention
Rivaroxaban 2.5 mg +3 moredrug
Likely dose
Rivaroxaban 2.5 mgfrom 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 Randomized, Double-Blind, Placebo-Controlled, Event-Driven Multicenter Study to Evaluate the Efficacy and Safety of Rivaroxaban in Subjects With a Recent Acute Coronary Syndrome
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·interventional·Posted Dec 17, 2008·Updated Sep 17, 2014
In Brief
A Phase 3 clinical trial evaluating Rivaroxaban 2.5 mg, Rivaroxaban 5 mg, and 2 other interventions for Acute Coronary Syndrome and 3 related conditions. Completed, enrolled 15,526 participants across 556 sites in 43 countries.
Detailed Summary
The purpose of this study is to determine whether rivaroxaban in addition to standard care reduces the risk of the composite of cardiovascular death, myocardial infarction, or stroke in patients with a recent acute coronary syndrome compared with placebo.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesArgentina, Australia, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colombia, Croatia, Czechia, Denmark, Egypt, France, Germany, Greece, Hungary, India, Israel, Japan, Latvia, Lithuania, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Philippines, Poland, Portugal, Romania, Russia, Serbia, Slovakia, South Korea, Spain, Sweden, Thailand, Tunisia, Turkey (Türkiye), Ukraine, United Kingdom, United States
CollaboratorsBayer
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartNov 2008
First PostedDec 2008
Primary CompletionSep 2011
TodayJul 2026
First PostedDec 17, 2008
Enrollment StartNov 1, 2008
Primary CompletionSep 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 17.5 years ago
Interventions
Rivaroxaban 2.5 mgdrug
One tablet twice daily
Rivaroxaban 5 mgdrug
One tablet twice daily
Placebodrug
One placebo tablet twice daily
Standard of caredrug