Study Type
Interventional - Drug
completed
The RELY-ABLE study comprised of:
- The long-term, multi-center extension of dabigatran treatment in patients with atrial fibrillation (AF) who completed the RE-LY trial
- A cluster randomised trial to assess the effect of a knowledge translation intervention on patient outcomes
The objective of the RELY-ABLE study was to establish the long-term safety of dabigatran etexilate, and to assess the efficacy of a knowledge translation intervention on the prognosis, cardiovascular risk profile and quality of care in patients with AF.
Since the objective of this trial was safety, there were no primary efficacy endpoints. Safety will primarily be determined by the occurrence of major bleeding.
Secondary endpoint:
Individual and composite incidence of stroke, non CNS systemic embolism, pulmonary embolism, acute myocardial infarction, deep vein thrombosis and all deaths.
Outcome events were adjudicated.
Study Design
Treatment, parallel group design, safety study.
NO. of Countries
35
NO. of Sites
598
NO. of Participants
5851
Study Period
2008 - 2013
Sponsor
PHRI
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.
completed
RE-LY
Arrhythmia & Heart Failure
The objective of the RE-LY study was to demonstrate the efficacy and safety of dabigatran...
completed
RE-LY AF Registry
Arrhythmia & Heart Failure
The objective of the RE-LY AF Registry was to evaluate and document the variations in...
