EdoxabaN foR IntraCranial Hemorrhage Survivors With Atrial Fibrillation (ENRICH-AF)
NCT03950076 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 948
Last updated 2026-02-25
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.
Conditions
- Intracranial Hemorrhages
- Atrial Fibrillation
Interventions
- DRUG
-
Edoxaban
Edoxaban 60mg (or 30mg as determined by clinical criteria)
- OTHER
-
Non-anticoagulant medical therapy
Non-anticoagulant medical therapy as determined by the local investigator includes i) No antithrombotic therapy ii) Antiplatelet monotherapy, including de novo indication for antiplatelet monotherapy during course of the study
Sponsors & Collaborators
-
Population Health Research Institute
lead OTHER
Principal Investigators
-
Ashkan Shoamanesh, MD, FRCPC · Population Health Research Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 45 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-09-20
- Primary Completion
- 2026-05-13
- Completion
- 2026-05-13
- FDA Drug
- Yes
Countries
- United States
- Argentina
- Austria
- Belgium
- Canada
- China
- Czechia
- Egypt
- Germany
- India
- Nepal
- Portugal
- Spain
- Switzerland
- United Kingdom
Study Locations
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