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Research

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COMPASS

Official Title

A Randomized Controlled Trial of Rivaroxaban for the Prevention of Major Cardiovascular Events in Patients With Coronary or Peripheral Artery Disease (COMPASS – Cardiovascular OutcoMes for People Using Anticoagulation StrategieS)

Status

Ongoing

Overview

Randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with CAD or PAD. If participant not currently on PPI, randomization to pantoprazole/placebo for the reduction of gastrointestinal bleeding, ulceration, and gastrointestinal obstruction or perforation in subjects with CAD or PAD receiving antithrombotic medications.

Study Design

Randomized, blinded, partial factorial, 3×2, parallel group design, multicenter, event-driven study. All patients must successfully complete a 4-week run-in phase on low-dose of rivaroxaban prior to being randomized.

Primary Endpoint

Primary efficacy outcome: Time from randomization to the first occurrence of either myocardial infarction, stroke, or cardiovascular death, over approximately 5 years
Primary safety outcome: Time from randomization to the first occurrence of major bleeding (modified International Society on Thrombosis and Haemostasis), over approximately 5 years

Number of Patients

27395

Number of Sites

602

Number of Countries

33

Study Period

2013–2018

Principal Investigator

Stuart Connolly, John Eikelboom

Program Manager

Jackie Bosch

Research Coordinator

Astrid Cuncins-Hearn, Kevin Reeh, Jane Belanger

Collaborators

Bayer