Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke
NCT06900725 · Status: NOT_YET_RECRUITING · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300
Last updated 2025-04-02
Summary
This prospectively enrolled, pragmatic randomized trial aims to investigate whether very low dose edoxaban regimen (15 mg daily) achieves similar edoxaban concentrations as low dose edoxaban regimen (30 mg daily), while maintaining a comparable risk of clinical outcomes and reducing major bleeding in elderly patients with atrial fibrillation and a history of ischemic stroke or transient ischemic attack.
Conditions
- Elderly
- Atrial Fibrillation (AF)
- Ischemic Stroke
Interventions
- DRUG
-
edoxaban
edoxaban 15 mg daily will be administered to the patients as secondary stroke prevention.
- DRUG
-
Edoxaban 30 mg
edoxaban 30 mg daily will be administered to the patients as secondary stroke prevention.
Sponsors & Collaborators
-
National Taiwan University Hospital, Yun-Lin Branch
collaborator OTHER -
National Taiwan University Hospital Hsin-Chu Branch
collaborator OTHER -
National Taiwan University Hospital
lead OTHER
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-04-01
- Primary Completion
- 2030-12-31
- Completion
- 2030-12-31
Countries
- Taiwan
Study Locations
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