NCT00809965

An Efficacy and Safety Study for Rivaroxaban in Patients With Acute Coronary Syndrome

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 15,526 (actual)
• Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Acute coronary syndrome (ACS) is a serious and life threatening condition. Following an acute coronary syndrome event patients are at risk of important additional clinical events such as death, myocardial infarction, and stroke. Six months after patients present with an index event of ST-segment myocardial infarction, approximately 15% will either have died or had another episode of myocardial ischemia, and a similar situation exists for non-ST-segment elevation myocardial infarction/unstable angina patients. This randomized; double-blind; placebo controlled study will evaluate the efficacy and safety of rivaroxaban in addition to standard care in patients with a recent ACS. Patients will be given rivaroxaban (2.5 mg twice daily or 5 mg twice daily) or placebo (twice daily) in addition to standard care.

Conditions

• Acute Coronary Syndrome
• Myocardial Infarction
• Myocardial Ischemia
• Unstable Angina

Interventions

Type	Name	Description
DRUG	Rivaroxaban 2.5 mg	One tablet twice daily
DRUG	Rivaroxaban 5 mg	One tablet twice daily
DRUG	Placebo	One placebo tablet twice daily
DRUG	Standard of care

Timeline

• Start date: 2008-11-01
• Primary completion: 2011-09-01
• Completion: 2011-09-01
• First posted: 2008-12-17
• Last updated: 2014-09-17
• Results posted: 2014-06-02

Locations

556 sites across 43 countries: United States, Argentina, 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