Interventional - Drug
The objective of Navigate ESUS, a multicenter, randomized, double-blind, double-dummy, active-comparator, event-driven, superiority phase III study, was to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolic events in patients with a recent embolic stroke of undetermined source (ESUS).
Patients who fulfilled all inclusion, and none of the exclusion criteria after giving informed consent, were randomly allocated 1:1 to either rivaroxaban 15mg or aspirin 100mg orally once daily. Randomization was stratified by country and age <60 and ≥60 years. No more than 10% of the total patient population was randomized into the age group <60 years.
The study was event-driven and thus all patients were treated (or followed-up in case of premature discontinuation of study medication) until the required approximately 450 confirmed primary efficacy outcomes are expected to have occurred.
The primary efficacy objective was to evaluate whether rivaroxaban is superior to aspirin in reducing the risk of recurrent stroke and systemic embolism in patients with a recent ESUS
The secondary efficacy objective was to evaluate whether rivaroxaban is superior to aspirin in reducing cerebrovascular events, cardiovascular events, and mortality in patients with a recent ESUS
The safety objective was to document the incidence of clinically relevant bleeding.
Interventional - Drug
Multicenter, randomized, double-blind, double-dummy
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.
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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