Status:
NOT_YET_RECRUITING
Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke
Lead Sponsor:
National Taiwan University Hospital
Collaborating Sponsors:
National Taiwan University Hospital, Yun-Lin Branch
National Taiwan University Hospital Hsin-Chu Branch
Conditions:
Elderly
Atrial Fibrillation (AF)
Eligibility:
All Genders
80+ years
Phase:
PHASE2
PHASE3
Brief 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 (...
Detailed Description
Edoxaban, a factor Xa inhibitor, is used to prevent stroke or systemic thromboembolism (SSE) in patients with atrial fibrillation (AF). In elderly patients, the post-hoc analysis of the Effective Anti...
Eligibility Criteria
Inclusion
- Age\>=80 years
- Has been diagnosed atrial fibrillation
- Has history of ischemic stroke or transient ischemic attack
- Has any of the bleeding risk lists below
- bodyweight \< 60 kg
- creatinine clearance \< 50 mL/min
- history of major bleeding or gastrointestinal bleeding
- concurrent use of antiplatelet agents (such as aspirin, clopidogrel, ticagrelor, prasugrel, cilostazol), non-steroidal anti-inflammatory drugs, amiodarone, tacrolimus, cyclosporine, dronedarone.
Exclusion
- Has ever used anticoagulants, defined as:
- warfarin therapy within 1 month before study enrollment.
- using heparin, low molecular weight heparin or direct oral anticoagulants within 7 days before study enrollment.
- allergy to edoxaban
- under regular dialysis, includes hemodialysis or peritoneal dialysis
- refuse to provide informed consent.
Key Trial Info
Start Date :
April 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2030
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06900725
Start Date
April 1 2025
End Date
December 31 2030
Last Update
April 2 2025
Active Locations (1)
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1
National Taiwan University Hospital
Taipei, Taiwan, 100