Interventional - Drug
To evaluate whether edoxaban is superior to standard medical therapy in reducing the risk of stroke in high-risk atrial fibrillation patients with previous intracranial hemorrhage. Patients who fulfill all inclusion and none of the exclusion criteria after giving informed consent will be randomly allocated 1:1 to either edoxaban 60 mg (dose adjusted to 30 mg) daily or standard medical therapy (either no antithrombotic therapy or antiplatelet monotherapy). Randomization will be stratified by center and by qualifying intracranial hemorrhage subtype (subdural vs. non-subdural). The study is event-driven and thus, all patients will be treated (or followed-up in case of premature discontinuation of study medication) until 123 confirmed primary efficacy outcomes have occurred.
“The primary efficacy objective is to evaluate whether edoxaban (60/30 mg daily) compared to standard of care (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) in high-risk atrial fibrillation patients with previous intracranial hemorrhage.
The primary safety objective is to document the incidence of clinically relevant major bleeding.Download Presentation PDF
Interventional - Drug
Randomized, open, blinded end-point
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.
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
Ashkan Shoamanesh is the founding Director, Hemorrhagic Stroke Research Program and Scientist, at PHRI, Assistant Professor of Medicine (Neurology), McMaster University, and Director, Stroke Fellowship Program at Hamilton Health Sciences and McMaster. He is the inaugural Marta and Owen Boris Chair in Stroke Research and Care at McMaster. His research is focused on improving the clinical care of patients with stroke or who are at risk for stroke resulting from blood vessel rupture and bleeding into the brain.He is the founding Chair of the Canadian Hemorrhagic Stroke Trials Initiative (CoHESIVE) and leads as principal investigator the global phase III ENRICH-AF trial investigating optimal stroke prevention in intracranial hemorrhage survivors with atrial fibrillation in 22 countries.
He has been awarded the most prestigious early career awards in stroke granted by the American Heart/Stroke Association (2015 Mordecai Y.T. Globus and 2019 Robert G. Siekert New Investigator Awards in Stroke), American Academy of Neurology (2020 Michael S. Pessin Stroke Leadership Prize), and Heart and Stroke Foundation of Canada (2019 Henry J.M. Barnett Scholarship – recognizing the highest ranked National New Investigator in cerebrovascular disease research), amongst other notable awards, including the 2019 International Stroke Conference Paul Dudley White International Scholar Award and the 2014 European Stroke Conference Young Investigator Award.
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.
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