Interventional - Drug
CATIS-ICAD is the first pilot RCT assessing safety of low-dose rivaroxaban plus ASA in patients with recent ischemic stroke/high-risk TIA secondary to intracranial atherosclerotic disease (ICAD), an area where a huge interest exists within the stroke community.
Demonstrating comparable safety to antiplatelet therapy is likely to have far reaching clinical impact, as this combination therapy then potentially could be used for patients with both intracranial and extracranial atherosclerotic disease. (The COMPASS trial already established that it is safe and effective in stroke prevention in extracranial atherosclerotic disease.)
Demonstration of safety and a trend towards efficacy in rivaroxaban plus ASA arm when compared with the ASA arm will provide a platform for a phase III efficacy trial.CATIS-ICAD Protocol - Download PDF
Interventional - Drug
Randomized, open-label, blinded endpoint, pilot trial
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.
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.
Associate Program Manager
Ellison Themeles’ experience includes more than 20 years in the conduct, execution and management of large, international clinical trials involving both medical devices and pharmaceutical agents in the area of cardiovascular disease and arrhythmias.
She holds a Bachelor of Arts degree in Gerontology and Sociology, and a Master of Science Degree in Health Research Methodology, from McMaster University.
Senior Research Coordinator
Amanda Taylor is a Senior Research Coordinator who joined PHRI in 2007. She currently coordinates trials in stroke, and has experience conducting trials in acute coronary syndrome and arrhythmia. She holds a Bachelor of Science Degree (Honours) in Neurobiology from Brock University.
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