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

NCT05540587 | Recruiting Phase 2

• 1 other identifier: KC21MIDS0296
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 7

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.

Conditions

Mitral Valve Stenosis; Atrial Fibrillation; Stroke; Systemic Embolism

Keywords

Edoxaban; Warfarin; Stroke; Systemic embolism; Mitral Valve Stenosis; Atrial Fibrillation

Outcome Measures

Primary Outcomes (1)

• Composite of Stroke or Systemic arterial thromboembolism

  The number of patients with the first occurrence of a stroke or systemic embolism during the study period

  15 days after randomization

Secondary Outcomes (3)

• Stroke

  15 days after randomization

• Systemic embolism

  15 days after randomization

• Death from any cause

  15 days after randomization

Study Arms (2)

Edoxaban

EXPERIMENTAL

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: Edoxaban

Warfarin

ACTIVE COMPARATOR

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.

Drug: Warfarin

Interventions

Edoxaban DRUG

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)

Edoxaban

Warfarin DRUG

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.

Warfarin

Eligibility Criteria

• Age: 19 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \< 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

You may not qualify if:

• Refusal to consent
• Transient AF due to reversible cause (Postoperative, ongoing systemic inflammation, thyrotoxicosis)
• Patients undergoing mechanical valve replacement
• Coagulopathy
• Hepatic impairment with significant bleeding risk
• High bleeding risk due to following disease or condition diagnosed within 1 month prior to randomization
• GI ulcer or bleeding, Esophageal or gastric varix, Malignancy, Brain or cord injury, Surgery for brain, spinal cord, opthalmic, Intracranial hemorrhage, Arteriovenous malformation, Vascular aneurysms, Brain or spinal vascular disorder
• Stroke, Systemic arterial thromboembolism, Acute myocardial infarction diagnosed within 14 days prior to randomization
• End stage kidney disease (CrCL \< 15mL/min) or Dialysis
• Severe hypertension
• Alcohol abuse or other psychiatric disease
• Epidural puncture or anesthesia
• Pulmonary thromboembolism with hemodynamical instability requiring thrombolysis or thrombectomy
• Pregnant or lactating women
• Allergy to edoxaban or warfarin

Sponsors & Collaborators

• Sung-Hwan Kim: lead
• Daiichi Sankyo Korea Co., Ltd.: collaborator

Study Sites (7)

Seoul St. Mary's Hospital

Seoul, Seocho-gu, 06591, South Korea

RECRUITING

Yeouido St. Mary's hospital

Yeongdeungpo-gu, Seoul, 07345, South Korea

RECRUITING

Bucheon St. Mary's hospital

Bucheon-si, 14647, South Korea

RECRUITING

Daejeon St. Mary's hospital

Daejeon, 34943, South Korea

RECRUITING

Incheon St. Mary's hospital

Incheon, 21431, South Korea

RECRUITING

St. Vincent hospital

Suwon, 16247, South Korea

RECRUITING

Uijeongbu St. Mary's Hospital

Uijeongbu-si, 11765, South Korea

RECRUITING

MeSH Terms

Conditions

Mitral Valve Stenosis; Atrial Fibrillation; Stroke

Interventions

edoxaban; Warfarin

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Central Study Contacts

Sung hwan Kim, MD, PhD

CONTACT

82-2-2258-6071; sunghwan@catholic.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 14, 2022
• Study Start: May 20, 2022
• Primary Completion: May 20, 2024
• Study Completion (Estimated): May 20, 2026
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

KR (7)