RecruitingPhase 2NCT05540587

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

A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis


Sponsor

Sung-Hwan Kim

Enrollment

240 participants

Start Date

May 20, 2022

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 19 YearsMax Age: 79 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether edoxaban — a blood-thinning pill — is effective and safe for preventing strokes and blood clots in patients who have both atrial fibrillation (an irregular heartbeat) and mitral valve stenosis (a narrowing of one of the heart valves). This group of patients is often excluded from standard blood-thinner trials, so the evidence for treatment is limited. **You may be eligible if:** - You are between 18 and 80 years old - You have been diagnosed with atrial fibrillation (confirmed by ECG) - You have moderate or severe mitral valve stenosis (confirmed by echocardiogram) **You may NOT be eligible if:** - You refuse to give consent - Your atrial fibrillation is caused by a reversible condition (such as post-surgery, thyroid disease, or infection) - You have a mechanical heart valve replacement - You have a blood clotting disorder - You have significant liver disease or high bleeding risk (e.g., recent gastrointestinal bleeding, recent brain surgery, or intracranial hemorrhage) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEdoxaban

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)

DRUGWarfarin

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

View Full Details on ClinicalTrials.gov

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NCT05540587


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