Study Progression Status | Number of Sites | Number of Patients Enrolled |
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Enrolling | Target: 250 | Target: 4000 |
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 250 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.
Investigators:
Jeff Healey, M.D. | Population Health Research Institute |
Stuart Connolly, M.D. | Population Health Research Institute |
Marco Alings, M.D. | Working Group Cardiovascular Research Netherlands |
Renato Lopes, M.D. | Duke Clinical Research Institute |
Countries Participating
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