Study Type
Interventional - Drug
ongoing
The AXIOMATIC SSP study is a global, phase 2, randomized, double-blind, placebo-controlled, dose-ranging Study of BMS-987177, an oral factor XIa inhibitor, for the prevention of new ischemic stroke or new silent brain infraction in patients receiving aspirin and clopidogrel following acute non-hemorrhagic stroke or transient ischemia attack (TIA).
The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to aspirin and clopidogrel is more effective than standard therapy in secondary stroke prevention.
More about this study at: ClinicalTrials.gov.
Study Design
Double-blind placebo-controlled dose-ranging RCT
NO. of Countries
27
NO. of Sites
367
NO. of Participants
2802
Study Period
2019 - 2022
Sponsor
Bristol Myers Squibb, Janssen
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.
Kanjana Perera
Investigator
Kanjana Perera
Investigator
Kanjana (Sashi) Perera is an Investigator in the Brain Health research program at PHRI, Assistant Professor, Medicine (neurology), McMaster University, and a stroke neurologist at Hamilton Health Sciences. Her main research focus is on secondary stroke prevention, cryptogenic stroke, and uncommon causes of stroke and the optimization of clinical care in this patient population.
She has served as Principal Investigator and Co-Investigator for Phase II and III clinical trials, and is on the adjudication committees for international multicenter stroke/cardiovascular trials. She has won research awards, and her work has been published in high-impact medical journals. She obtained her medical degree from Sri Lanka with Honors for academic excellence. She completed her training in Neurology at the University of Western Ontario in 2013 and subsequently pursued a fellowship in Stroke/Vascular Neurology at McMaster University.
Dipika Desai
Program Manager
Dipika Desai
Program Manager
Dipika Desai oversees many epidemiologic studies, including the South Asian birth cohort, START, the South Asian Heart Risk Assessment (SAHARA), and the Canadian Alliance for Healthy Hearts and Minds (CAHHM), as well as management assistance and oversight in the utilization of samples from a number of other studies.
She has a Bachelor’s degree in Food and Nutrition from the M S University in Baroda, India, and a Master’s degree in Human Nutrition from the University of British Columbia.
Jodi Miller
Senior Research Coordinator
Jodi Miller
Senior Research Coordinator
Jodi Miller has more than 15 years experience in academic research. She has been at PHRI since 2012 where she has coordinated large international industry and investigator initiated trials. In her current role she coordinates clinical trials and clinical quality assurance projects in stroke.
Jodi has a BSc in Physics from Mount Allison University and a PhD in Medical Biophysics with a focus on magnetic resonance imaging applications from Western University.
