The COMPASS MRI substudy was 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.

COMPASS-MIND was a phase II trial seeking evidence of efficacy in a convenience sample of approximately 1500 participants randomized to the landmark COMPASS (Cardiovascular Outcomes for People Using Anticoagulation Strategies) study. The substudy was conducted concurrently with the main study, in a subset of centers with access to high-quality, reasonably priced magnetic resonance imaging (MRI).

This substudy offered 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.

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.

Study Type

Interventional - Drug

Study Design

MRI substudy (Phase 2)

NO. of Countries


NO. of Sites


NO. of Participants


Study Period

2013 - 2017



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