Study Type
Interventional - Drug
completed
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 Design
MRI substudy (Phase 2)
NO. of Countries
16
NO. of Sites
77
NO. of Participants
1422
Study Period
2013 - 2017
Sponsor
Bayer
Mike Sharma
Scientist
Mike Sharma
Scientist
Mike Sharma, MD MSc FRCPC, is the Director of the Stroke Program at McMaster University and Hamilton Health Sciences and holds the Michael G DeGroote Chair in Stroke Prevention, at McMaster University in Hamilton, Canada. His research interests include the development of new antithrombotic treatments, incorporating magnetic resonance imaging endpoints into the design of stroke prevention trials and examining the effects of anticoagulants on stroke recurrence and covert brain infarcts.
He has led trials and sub-studies in large prevention trials focused on these areas including COMPASS MIND, NAVIGATE ESUS, DATAS II and currently leads as principal investigator, the global phase II AXIOMATIC-SSP trial investigating FXI inhibition for stroke prevention in 27 countries.
He has published more than 140 articles in referred journals, is the immediate past Chair of the Canadian Stroke Consortium, the professional organization for stroke physicians and clinical trialists in Canada and established the stroke program at the University of Ottawa. Dr. Sharma is committed to developing integrated processes for stroke care and developing human and system capacity for the next generation of stroke trials.
Robert Hart
Senior Scientist
Robert Hart
Senior Scientist
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.
Jackie Bosch
Scientist
Jackie Bosch
Scientist
Jackie Bosch is the Assistant Dean of the McMaster Occupational Therapy Program and a PHRI Scientist. She has a Bachelor’s degree in Occupational Therapy, a Master’s degree in Clinical Epidemiology and Biostatistics, and a PhD in Rehabilitation Science. She also serves as a Professor in the School of Rehabilitation and has an Adjunct Appointment with the University of Galway College of Medicine, Nursing, and Health Sciences.
Her research focuses on improving functional outcomes in clinical trials, particularly for stroke survivors in low-resource settings, and enhancing clinical trial methods. Bosch has taken on leadership roles in large-scale trials such as HOPE, HOPE-TOO, HOPE-3 (NCT00468923), DREAM (NCT00095654), ORIGIN (NCT00069784), TIPS-3 (NCT01646437), and COMPASS (NCT01776424). She leads the Organized Stroke Care Across Income Levels (OSCAIL) group, which has conducted a proof-of-concept study implementing key aspects of stroke unit care in hospitals within low-resource settings. Currently, the OSCAIL group is working on a community-based study aimed at improving outcomes for stroke survivors in these challenging environments. Bosch is also interested in optimizing how clinical trials are conducted, especially by finding new ways to make the start-up and execution processes more efficient.
Jackie Bosch has published 184 articles and received several awards, including the Lorna Reimer Award for Leadership from the Canadian Occupational Therapy Foundation in 2019 and the Faculty of Health Sciences, McMaster University, Programs Award for Graduate Students in 2014.
completed
COMPASS
CVD Prevention
COMPASS was a randomized controlled trial that discovered that the use of rivaroxaban, a new...
