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RECRUITING
NCT05540587
PHASE2

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

Sponsor: Sung-Hwan Kim

View on ClinicalTrials.gov

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

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.

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