A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Status: Recruiting
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Maximum Age: 79
Healthy Volunteers: f
View:
⁃ 18 \< Age \< 80
• AF diagnosed by ECG at any time prior to enrollment
• Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time prior to enrollment
Locations
Other Locations
Republic of Korea
Bucheon St. Mary's hospital
RECRUITING
Bucheon-si
Daejeon St. Mary's hospital
RECRUITING
Daejeon
Incheon St. Mary's hospital
RECRUITING
Incheon
Seoul St. Mary's Hospital
RECRUITING
Seoul
St. Vincent hospital
RECRUITING
Suwon
Uijeongbu St. Mary's Hospital
RECRUITING
Uijeongbu-si
Yeouido St. Mary's hospital
RECRUITING
Yeongdeungpo-gu
Contact Information
Primary
Sung hwan Kim, MD, PhD
sunghwan@catholic.ac.kr
82-2-2258-6071
Time Frame
Start Date: 2022-05-20
Estimated Completion Date: 2026-05-20
Participants
Target number of participants: 240
Treatments
Experimental: 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)
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Sung-Hwan Kim
Collaborators: Daiichi Sankyo Korea Co., Ltd.