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

Phase 2

Recruiting

• Conditions: Mitral Valve Stenosis; Atrial Fibrillation; Stroke; Systemic Embolism
• Interventions: Drug: Edoxaban; Drug: Warfarin

• Registration Number: NCT05540587
• Lead Sponsor: Sung-Hwan Kim

Brief 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.

Detailed Description

Non-vitamin K antagonist oral anticoagulants (NOACs) are generally recommended as 1st line therapy for oral anticoagulant in patients with atrial fibrillation (AF). But, the efficacy and safety of NOAC in AF patients with prosthetic mechanical heart valves or moderate to severe mitral valve stenosis have not been proven, and the guidelines recommend vitamin K antagonist (VKA) administration to those patient groups. This trial aims to compare the efficacy and safety of the edoxaban and the warfarin in AF patients with moderate to severe mitral valve stenosis.

Edoxaban in patients with aTrial fibrillation and MItral Stenosis (ERTEMIS) trial is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. The primary efficacy outcome is a composite of stroke and systemic arterial thromboembolism. The secondary efficacy outcomes are each component of the primary efficacy outcomes and death from any cause. The safety outcome was major bleeding.

Study Timeline

• Study Start: 2022-05-20
• Status Verified: 2022-09
• Study First Submitted: 2022-09-12
• Study First Submitted QC: 2022-09-12
• Last Update Submitted: 2022-09-12
• Study First Posted: 2022-09-14
• Last Update Posted: 2022-09-14
• Primary Completion: 2024-05-20
• Study Completion: 2026-05-20

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Edoxaban	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	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.

Primary Outcome Measures

Name	Time	Method
Composite of Stroke or Systemic arterial thromboembolism	15 days after randomization	The number of patients with the first occurrence of a stroke or systemic embolism during the study period

Secondary Outcome Measures

Name	Time	Method
Systemic embolism	15 days after randomization	The number of patients with the first occurrence of a systemic embolism during the study period
Death from any cause	15 days after randomization	The number of patients who died for any reason during the study period
Stroke	15 days after randomization	The number of patients with the first occurrence of a stroke during the study period

Trial Locations

Locations (7)

Bucheon St. Mary's hospital; 🇰🇷 Bucheon, Korea, Republic of

Yeouido St. Mary's hospital; 🇰🇷 Yeongdeungpo-gu, Seoul, Korea, Republic of

Seoul St. Mary's Hospital; 🇰🇷 Seoul, Seocho-gu, Korea, Republic of

St. Vincent hospital; 🇰🇷 Suwon, Korea, Republic of

Uijeongbu St. Mary's Hospital; 🇰🇷 Uijeongbu, Korea, Republic of

Incheon St. Mary's hospital; 🇰🇷 Incheon, Korea, Republic of

Daejeon St. Mary's hospital; 🇰🇷 Daejeon, Korea, Republic of