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Search / Trial NCT06900725

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

Launched by NATIONAL TAIWAN UNIVERSITY HOSPITAL · Mar 23, 2025

Trial Information

Current as of April 22, 2025

Not yet recruiting

Keywords

Very Low Dose Edoxaban Elderly Drug Concentration Major Bleeding Atrial Fibrillation

ClinConnect Summary

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 Anticoagulation with Factor Xa Next Generation in Atrial Fibrillation-Thrombolysis in Myocardial Infarction 48 (ENGAGE AF-TIMI 48) trial showed that a low-dose edoxaban regimen (LDER, 30 mg daily) reduced the risk of major bleeding compared to the standard-dose edoxaban regimen (SDER, 60 mg daily), without an offsetting increase in SSE risk. Furthermore, the Edoxaban Low-Dose for Elder Care Atrial ...

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.

About National Taiwan University Hospital

National Taiwan University Hospital (NTUH) is a leading medical institution renowned for its commitment to advancing healthcare through innovative research and clinical trials. As a pioneer in medical education and patient care in Taiwan, NTUH integrates cutting-edge technology with comprehensive clinical expertise to facilitate groundbreaking studies across various medical fields. The hospital’s dedicated research team collaborates with local and international partners to enhance the understanding of diseases and improve treatment outcomes. By prioritizing patient safety and ethical standards, NTUH strives to contribute to the global medical community and foster advancements in healthcare practices.

Locations

Taipei, , Taiwan

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported