Study Type
Interventional - Drug
ongoing
To determine if treatment with apixaban, compared with aspirin, will reduce the risk of stroke and systemic embolism in patients with device-detected sub-clinical atrial fibrillation (SCAF) and additional risk factors for stroke.
Current guidelines recommend treatment with oral anticoagulant for stroke prevention in clinical AF but opinion leaders are uncertain of the role of oral anticoagulants for patients with SCAF. 4000 patients from approximately 240 sites in Canada, USA and Europe will be randomized double-blind to receive apixaban (5mg bid or 2.5 mg bid as per labelling) or aspirin (81mg OD).
The study will be event-driven and will continue until 248 patients have experienced a primary outcome event (stroke or systemic embolism). Estimated mean follow-up time is 3 years.
Download Presentation PDFStudy Design
Multicentre, prospective, parallel group, double-blind design
NO. of Countries
16
NO. of Sites
230
NO. of Participants
4000
Study Period
2015-2022
Sponsor
PHRI
Jeff Healey
Senior Scientist
Jeff Healey
Senior Scientist
Jeff Healey is a Senior Scientist in the Arrhythmia and Heart Failure research program at PHRI, an Associate Professor, Medicine, McMaster University, and Director of Arrhythmia Services at Hamilton Health Sciences. His research involves conducting RCTs and large registries in the fields of atrial fibrillation and cardiac devices. He was the lead author of the SIMPLE trial, published in the Lancet in 2015, which demonstrated that implantable defibrillators could be safely inserted without performing intra-operative defibrillation testing.
He was the lead author of the ASSERT trial, published in New England Journal of Medicine in 2012, demonstrating the increased stroke risk associated with sub-clinical atrial fibrillation detected by pacemakers. Thomson-Reuters recognized ASSERT as the 38th most-cited scientific publication in 2012 (#16 in Medicine).
He was principal investigator and chair of the Canadian Stroke Prevention Intervention Network (CSPIN), a ten-year network grant funded by the Canadian Institutes of Health Research, The Heart and Stroke Foundation of Canada and Industry. He is the past co-chair of the Canadian Cardiovascular Society’s Atrial Fibrillation Guidelines Committee. Jeff has published more than 185 manuscripts.
Tara McCready
Program Director
Tara McCready
Program Director
Tara McCready, PhD, oversees a variety of collaborative programs at PHRI, and serves as Project Manager for PHRI research studies and registries.
She was recruited to PHRI as a Program Director for the Canadian Network and Centre for Trials Internationally (CANNeCTIN), a national network funded by the CIHR/CFI Clinical Research Initiative program to improve the prevention and treatment of cardiac and vascular diseases and diabetes.
Previously the Executive Director of the Canadian Maternal, Infant, Child and Youth Research Network, Tara holds a PhD in Biochemistry and a MBA in Technology Commercialization from the University of Alberta.
