Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Mar 23, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the effects of a very low dose of edoxaban (15 mg daily) in elderly patients who have atrial fibrillation (a heart condition that can lead to strokes) and have previously experienced a stroke or a mini-stroke. The goal is to see if this lower dose provides similar benefits as a low dose of 30 mg daily, while also reducing the risk of serious bleeding, which can be a concern in older patients.

To participate in the trial, individuals must be at least 80 years old and have a diagnosis of atrial fibrillation along with a history of ischemic stroke or mini-stroke. They should also have certain risk factors, such as low body weight or reduced kidney function. However, those who have recently used other blood thinners or who have specific health conditions may not be eligible. Participants can expect to receive careful monitoring throughout the trial to ensure their safety and to track the effectiveness of the medication. This trial is not yet recruiting patients, but it aims to provide important information that could help manage the treatment of elderly patients with these health challenges in the future.

Gender

ALL

Eligibility criteria

• 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.