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Units

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Financing

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Brief description/objective

Study Hypothesis:
In patients with evidence of device-detected sub-clinical atrial fibrillation (SCAF) and additional risk factors for stroke, treatment with apixaban compared with aspirin will reduce the risk of the composite of stroke and systemic embolism.

Study Objectives
To determine if the use of apixaban in patients with SCAF will reduce the incidence of stroke and systemic embolism compared to aspirin.

Primary Outcomes:
Efficacy: Composite of stroke (including transient ischemic attack (TIA) with evidence of cerebral infarction on diffusion-weighted MRI) and systemic embolism
Safety: Major bleeding as defined by the ISTH criteria

The study will enroll patients with a CHA2DS2-VASc score of at least 4 and who have an implanted pacemaker or defibrillator (with or without resynchronization) or an insertable cardiac monitor (ICM) which shows at least 6 minutes, but not more than 24 hours of sub-clinical atrial fibrillation.