edoxaban: edoxaban 15 mg daily will be administered to the patients as secondary stroke prevention.
Edoxaban 30 mg: edoxaban 30 mg daily will be administered to the patients as secondary stroke prevention.
Study 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.
Eligibility
Sex
ALL
Min age
80 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* 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 Criteria:
* 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.
Primary outcome measure(s)
The proportion of patients achieving edoxaban concentrations within the expected range — 1 month The proportion of patients achieving edoxaban concentrations within the expected range from the ENGAGE-AF TIMI 48 trial (12-43 ng/mL at trough) at 1 month.
Trial sites (1)
Facility
City
Region
Status
National Taiwan University Hospital
Taipei
Taiwan
More National Taiwan University Hospital trials in Taiwan
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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