Interventional - Drug
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.
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.
Interventional - Drug
MRI substudy (Phase 2)
2013 - 2017
Robert Hart is Professor of Medicine (Neurology) at McMaster University and a vascular neurologist at Hamilton Health Sciences. After completing a fellowship in cerebrovascular disease at the Oregon Health Sciences University, he spent most of his career at the University of Texas Health Science Center in San Antonio before relocating to McMaster University in September 2011.
He has a long-standing interest in stroke, stroke research, and clinical trials. He has directed several randomized clinical trials serving as the principal investigator of the NIH/NINDS-sponsored Stroke Prevention in Atrial Fibrillation (SPAF) I, II and III trials (1987-2000) and co-principal investigator of the NIH/NINDS-sponsored Secondary Prevention of Small Subcortical Strokes (SPS3) randomized trials (2001-2013). Antithrombotic therapies to prevent stroke in atrial fibrillation and especially novel oral anticoagulants are areas of special interest. He has published more than 250 articles in peer-reviewed journals.
Mike Sharma is a stroke neurologist at Hamilton Health Sciences, Associate Professor – Division of Neurology, Department of Medicine, McMaster University, and a scientist in the stroke program at PHRI. He has an interest in clinical trials in secondary stroke prevention, covert stroke, and economics of stroke care.
Mike is Chair of the Canadian Stroke Consortium, and was the Deputy Director for Clinical Affairs and Health Policy of the Canadian Stroke Network, one of Canada’s Networks of Centers of Excellence. He has published more than 31 papers in peer review journals. After completing his fellowship at McGill University and the University of Ottawa, Mike relocated to McMaster University in 2013.
Jackie Bosch started working with Salim Yusuf in 1993, before PHRI was formally created, as she was completing her Masters in Clinical Epidemiology, with the intent to learn how to do clinical trials so she could run trials in post-stroke rehabilitation. Most recently, she has been a co-investigator on large trials in primary and secondary prevention of cardiovascular disease and diabetes, as well as understanding the causes of functional decline as well as developing simple, internationally applicable interventions to improve post-stroke disability.
She is Assistant Dean of the Occupational Therapy program, School of Rehabilitation Sciences, McMaster University, and has received awards such as the (McMaster) President’s Award for Outstanding Service, and the PHRI Award for Outstanding Contributions to Global Collaborations. She has more than 65 peer-reviewed publications.
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