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.
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.
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.
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.
Mike Sharma, Robert Hart
Sharma M, Hart RG, Smith EE, Bosch J, Yuan F, Casanova A, Eikelboom JW, Connolly SJ, Wong G, Diaz R, Lopez-Jaramillo P, Ertl G, Störk S, Dagenais GR, Lonn EM, Ryden L, Tonkin AM, Varigos JD, Bhatt DL, Branch KR, Probstfield JL, Kim JH, Ha JW, O’Donnell M, Vinereanu D, Fox KA, Liang Y, Liu L, Zhu J, Pogosova N, Maggioni AP, Avezum A, Piegas LS, Keltai K, Keltai M, Cook Bruns N, Berkowitz S, Yusuf S. Rationale, design, and baseline participant characteristics in the MRI and cognitive substudy of the cardiovascular outcomes for people using anticoagulation strategies trial. Int J Stroke. 2019 Apr 1; 14(3):270-281. doi: 10.1177/1747493018784478. Epub 2018 Jul 30.