Interventional - Drug
The objective of the AVERROES LTOLE study was to provide ongoing open-label apixaban therapy to participants of the AVERROES trial until apixaban was approved and commercially available in their respective countries.
Participation in LTOLE was optional for all sites/participants of the AVERROES study, and required separate participant informed consent and approval from health authorities and local ethics committees.
Follow-up visits occurred at 1 month and every 6 months after enrollment into LTOLE, and continued until the participant withdrew or the decision was made to end the LTOLE study at a given country/site due to availability of commercial apixaban or suitable alternative.
Outcome and safety assessments are performed in a similar fashion as in AVERROES follow-up visits.
Participant safety was monitored and reported regularly, however there was no ‘endpoint.’
Interventional - Drug
2010 - 2017
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.
John Eikelboom is Associate Professor in the Department of Medicine, McMaster University, and a haematologist in the Thrombosis Service, Hamilton General Hospital. He originally trained in Internal Medicine and Haematology in Perth, Australia and subsequently moved to Hamilton to take up a Tier II Canada Research Chair in Cardiovascular Medicine.
He has co-authored more than 350 articles in peer-reviewed journals. His current research, supported by the Canadian Institutes for Health Research, the Heart and Stroke Foundation and the National Health and Medical Research Council of Australia, focuses on the efficacy and safety of antithrombotic therapies, outcomes after blood transfusion and bleeding, and the mechanisms of variable response to antiplatelet drugs.
PHRI International Fellow
Alexander Benz joined the Arrhythmia Research group at PHRI, supervised by Stuart Connolly, as a research fellow in January 2019, and is enrolled in the Health Research Methodology program at McMaster University. His primary research interest is clinical electrophysiology, with a particular focus on atrial fibrillation. Other areas of interest include oral anticoagulation in various settings, inflammation, cardiac implantable electronic devices and interventions such as catheter ablation.
He is actively involved in the conduct of large international clinical trials coordinated at PHRI. Alexander is the Principal Investigator of a randomized clinical trial testing a short-course treatment with colchicine in the setting of catheter ablation for atrial fibrillation that started enrollment in January 2020.
Alexander obtained his medical degree from Goethe University in Frankfurt (Germany) in 2015. He is pursuing a career in Cardiology.
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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