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

NCT00809965 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 15526

Last updated 2014-09-17

Study results available
· View outcomes & findings →

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

    lead INDUSTRY

Principal Investigators

  • Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial · Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-11-30
Primary Completion
2011-09-30
Completion
2011-09-30

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

Study Locations

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Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00809965 on ClinicalTrials.gov