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Research

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COMPASS-MIND

Official Title

Magnetic resonance imaging (MRI) substudy evaluating the incidence of clinically silent brain infarcts and subclinical brain ischemia (COMPASS-MIND).

COMPASS (Cardiovascular OutcoMes for People using Anticoagulation StrategieS) is a  randomized controlled trial of rivaroxaban for the prevention of major cardiovascular events in patients with coronary or peripheral artery disease.

Status

Completed

Overview

The COMPASS MRI substudy is the first randomized trial of an anticoagulant to prevent covert brain infarcts in patients with atherosclerotic vascular disease. Evidence that rivaroxaban reduces covert stroke better than, or in addition to, aspirin would have an immense potential public health impact. Within the COMPASS trial, the MRI substudy offers an opportunity to develop evidence of rivaroxaban efficacy for a separate clinical indication applicable to a burgeoning population. Blood samples will be collected for future analysis for selected biomarkers, some of which have been observed in other studies to be predictors of stroke, and others, which have a plausible association with cardiovascular outcomes.

Study Design

COMPASS-MIND is a phase II trial seeking evidence of efficacy in a convenience sample of approximately 1500 participants randomized to the COMPASS study. The substudy will be conducted concurrently with the main study in a subset of centers with access to high-quality, reasonably-priced MR imaging.

Primary Endpoint

The COMPASS-MIND substudy will examine the effect of the antithrombotic therapies being tested in COMPASS on covert cerebral ischemia, thereby providing additional information about mechanisms of disease and treatment benefits.

Number of Patients

1422

Number of Sites

77

Number of Countries

16

Study Period

2013-2017

Principal Investigator

Mike Sharma, Robert Hart

Program Manager

Jackie Bosch

Research Coordinator

Kevin Reeh

Collaborators

Bayer