Rivaroxaban for the Prevention of Major Cardiovascular Events in Coronary or Peripheral Artery Disease

Summary

The primary objectives of this study are:

* To determine whether rivaroxaban 2.5 mg twice daily (bid) + aspirin 100 mg once daily (od) compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke, or cardiovascular death in subjects with coronary artery disease (CAD) or peripheral artery disease (PAD);
* To determine whether rivaroxaban 5 mg bid compared with aspirin 100 mg od reduces the risk of a composite of myocardial infarction, stroke or cardiovascular death in subjects with CAD or PAD.

Conditions

• Prevention & Control

Interventions

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 2.5 mg, twice daily, oral

DRUG

Rivaroxaban (Xarelto, BAY59-7939)

Tablet, 5 mg, twice daily, oral

DRUG

Aspirin

Tablet, 100 mg, once daily, oral

DRUG

Aspirin placebo

Aspirin matching placebo, once daily, oral

DRUG

Rivaroxaban placebo

Rivaroxaban matching placebo, twice daily, oral

DRUG

Pantoprazole

Tablet, 40 mg, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole

DRUG

Pantoprazole placebo

Pantoprazole matching placebo, once daily, oral, for participants who were not on a PPI and who were randomized to pantoprazole placebo

Sponsors & Collaborators

• Population Health Research Institute

  collaborator OTHER

• Janssen Research & Development, LLC

  collaborator INDUSTRY

• Bayer

  lead INDUSTRY

Principal Investigators

• Bayer Study Director · Bayer

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-02-28

Primary Completion

2017-07-21

Completion

2021-06-15

FDA Drug

Yes

Countries

• United States
• Argentina
• Australia
• Belgium
• Brazil
• Canada
• Chile
• China
• Colombia
• Czechia
• Denmark
• Ecuador
• Finland
• France
• Germany
• Hungary
• Ireland
• Israel
• Italy
• Japan
• Malaysia
• Netherlands
• Philippines
• Poland
• Romania
• Russia
• Slovakia
• South Africa
• South Korea
• Sweden
• Switzerland
• Ukraine
• United Kingdom

Study Locations