NCT06900725Not yet recruitingPhase 2/3
Low Dose Edoxaban in Elderly Patients With AF and a History of Stroke
Low-Dose Edoxaban Versus Very-Low-Dose Edoxaban in Elderly Patients With Atrial Fibrillation and a History of Stroke (LEAVE-Stroke): A Pragmatic Randomized Clinical Trial
Source: ClinicalTrials.gov · Last updated 2 Apr 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 2/3
- Study type
- Interventional
- Enrollment
- 300 (estimated)
- First submitted
- 23 Mar 2025
- Start date
- 1 Apr 2025
- Primary completion date
- 31 Dec 2030
- Lead sponsor
- National Taiwan University Hospital
- Diseases
- Stroke, Atrial fibrillation
- NCT number
- NCT06900725
What you commit to
- Study type: Interventional · Phase 2/3
- Planned participants: 300
- From 1 Apr 2025 to the primary completion date, 31 Dec 2030
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- warfarin therapy within 1 month before study enrollment.
- using heparin, low molecular weight heparin or direct oral anticoagulants within 7 days before study enrollment.
Other illness
- allergy to edoxaban
Other
- Has ever used anticoagulants, defined as:
- under regular dialysis, includes hemodialysis or peritoneal dialysis
- refuse to provide informed consent.
Who the study is looking for
- 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.
Age in the registry: 80 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| National Taiwan University Hospital Coordinator of this site? Confirm its status | Taipei | Taiwan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.