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Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Sponsor: Sung-Hwan Kim
Summary
This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis. The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outcome was major bleeding.
Official title: A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Key Details
Gender
All
Age Range
19 Years - 79 Years
Study Type
INTERVENTIONAL
Enrollment
240
Start Date
2022-05-20
Completion Date
2026-05-20
Last Updated
2022-09-14
Healthy Volunteers
No
Interventions
Edoxaban
Patients in the Edoxaban group take Edoxaban 60mg once daily. If any of the following conditions are present, take 30mg once daily. * CrCl 15-50mL/min * Body weight ≤ 60kg * Concomitant use of P-glycoprotein inhibitor (Dronearone, Ciclosporine, Erythromycin or Ketoconazole)
Warfarin
Patients in the Warfarin group take Warfarin 2-10mg once daily, dose adjusted with the target INR 2-3. In the elderly or frail patients, a lower dose administration is allowed at the discretion of the investigator.
Locations (7)
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea
Yeouido St. Mary's hospital
Yeongdeungpo-gu, Seoul, South Korea
Bucheon St. Mary's hospital
Bucheon-si, South Korea
Daejeon St. Mary's hospital
Daejeon, South Korea
Incheon St. Mary's hospital
Incheon, South Korea
St. Vincent hospital
Suwon, South Korea
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea