EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF) (NCT03950076) | Clinical Trial Compass
Active — Not RecruitingPhase 4
EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
United States948 participantsStarted 2019-09-20
Plain-language summary
To assess whether edoxaban (60/30 mg daily) compared to non-antithrombotic medical therapy (either no antithrombotic therapy or antiplatelet monotherapy) reduces the risk of stroke (composite of ischemic, hemorrhagic and unspecified stroke) or systemic embolism in high-risk atrial fibrillation (CHA2DS2-VASc ≥2) patients with previous intracranial hemorrhage.
Who can participate
Age range45 Years
SexALL
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Inclusion criteria
✓. Written informed consent provided
✓. Age ≥45 years, at the time of signing the informed consent
✓. Previous intracranial hemorrhage (symptomatic, spontaneous and non-traumatic non-lobar intraparenchymal or intraventricular hemorrhage, and symptomatic spontaneous or non-penetrating traumatic subdural hemorrhages) on or off antithrombotic therapy
✕. Secondary macrovascular, neoplastic or infectious causes of intracranial hemorrhage (except for antithrombotic treatment or non-penetrating traumatic subdural hemorrhages)
✕. Isolated subarachnoid hemorrhage (convexity or basal); subarachnoid blood tracking onto convexity secondary to an intraventricular hemorrhage or as part of a multicompartment bleed in cases of traumatic subdural hemorrhages are eligible
✕. Need for ongoing oral anticoagulant therapy for indication other than AF (e.g. mechanical heart valve, venous thromboembolic disease)
✕. Need for ongoing antiplatelet therapy for indication where edoxaban would not be a suitable substitute
✕. Plans for left atrial appendage occlusion
What they're measuring
1
Stroke or Systemic Embolism
Timeframe: From randomization until the common study end date (average of 3 years)
2
Major hemorrhage
Timeframe: From randomization until the common study end date (median 2 years)