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.

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Study Type

Interventional - Drug

Study 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

Bristol-Myers Squibb

Canadian Institutes of Health Research (CIHR)

Medtronic

Hamilton Health Sciences

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