Study Type
Interventional - Drug
completed
The obective of the EXPLORE Xa study was to assess the safety and tolerability of betrixaban at doses of 40 mg, 60 mg and 80 mg given orally once a day for at least 3 months compared to dose-adjusted warfarin in patients with non-valvular atrial fibrillation (AF).
Primary endpoint:
The time to occurrence of majoror clinically relevant non-major bleeding.
Secondary endpoints:
The time to occurrence of any bleeding (including major, clinically relevant non-major, and minimal) and the time to occurrence of death, ischemic or nonischemic stroke, MI, or other systemic embolism.
Study Design
Randomized, parallel group design, multicenter, active comparator, dose-finding
NO. of Countries
4
NO. of Sites
42
NO. of Participants
508
Study Period
2008 - 2010
Sponsor
Portola Pharmaceuticals
Stuart Connolly
Stuart Connolly
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.
Ellison Themeles
Associate Program Manager
Ellison Themeles
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.
