Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

PHASE2RecruitingINTERVENTIONAL
Enrollment

240

Participants

Timeline

Start Date

May 20, 2022

Primary Completion Date

May 20, 2024

Study Completion Date

May 20, 2026

Conditions
Mitral Valve StenosisAtrial FibrillationStrokeSystemic Embolism
Interventions
DRUG

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)"

DRUG

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.

Trial Locations (7)

11765

RECRUITING

Uijeongbu St. Mary's Hospital, Uijeongbu-si

14647

RECRUITING

Bucheon St. Mary's hospital, Bucheon-si

16247

RECRUITING

St. Vincent hospital, Suwon

21431

RECRUITING

Incheon St. Mary's hospital, Incheon

34943

RECRUITING

Daejeon St. Mary's hospital, Daejeon

06591

RECRUITING

Seoul St. Mary's Hospital, Seoul

07345

RECRUITING

Yeouido St. Mary's hospital, Yeongdeungpo-gu

All Listed Sponsors
collaborator

Daiichi Sankyo Korea Co., Ltd.

INDUSTRY

lead

Sung-Hwan Kim

OTHER