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

Primary Purpose

Mitral Valve Stenosis, Atrial Fibrillation, Stroke

Status
Recruiting
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Edoxaban
Warfarin
Sponsored by
Sung-Hwan Kim
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mitral Valve Stenosis focused on measuring Edoxaban, Warfarin, Stroke, Systemic embolism, Mitral Valve Stenosis, Atrial Fibrillation

Eligibility Criteria

19 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

  • Inclusion criteria

    • 18 < 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

  • Exclusion criteria

    • 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
    • Ongoing need for other anticoagulant or clarithromycin, rifampin)
    • Participants for other trials within 1 month prior to enrollment
    • Other patients to be inappropriate to participate in the trial determined by the investigator

Sites / Locations

  • Seoul St. Mary's HospitalRecruiting
  • Yeouido St. Mary's hospitalRecruiting
  • Bucheon St. Mary's hospitalRecruiting
  • Daejeon St. Mary's hospitalRecruiting
  • Incheon St. Mary's hospitalRecruiting
  • St. Vincent hospitalRecruiting
  • Uijeongbu St. Mary's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Edoxaban

Warfarin

Arm Description

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)

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Stroke
The number of patients with the first occurrence of a stroke during the study period
Systemic embolism
The number of patients with the first occurrence of a systemic embolism during the study period
Death from any cause
The number of patients who died for any reason during the study period

Full Information

First Posted
September 12, 2022
Last Updated
September 12, 2022
Sponsor
Sung-Hwan Kim
Collaborators
Daiichi Sankyo Korea Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05540587
Brief Title
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Acronym
ERTEMIS
Official Title
A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 20, 2022 (Actual)
Primary Completion Date
May 20, 2024 (Anticipated)
Study Completion Date
May 20, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sung-Hwan Kim
Collaborators
Daiichi Sankyo Korea Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Stenosis, Atrial Fibrillation, Stroke, Systemic Embolism
Keywords
Edoxaban, Warfarin, Stroke, Systemic embolism, Mitral Valve Stenosis, Atrial Fibrillation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Edoxaban
Arm Type
Experimental
Arm Description
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)
Arm Title
Warfarin
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Edoxaban
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Warfarin
Intervention Description
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 Measure Information:
Title
Composite of Stroke or Systemic arterial thromboembolism
Description
The number of patients with the first occurrence of a stroke or systemic embolism during the study period
Time Frame
15 days after randomization
Secondary Outcome Measure Information:
Title
Stroke
Description
The number of patients with the first occurrence of a stroke during the study period
Time Frame
15 days after randomization
Title
Systemic embolism
Description
The number of patients with the first occurrence of a systemic embolism during the study period
Time Frame
15 days after randomization
Title
Death from any cause
Description
The number of patients who died for any reason during the study period
Time Frame
15 days after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria 18 < 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 Exclusion criteria 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 Ongoing need for other anticoagulant or clarithromycin, rifampin) Participants for other trials within 1 month prior to enrollment Other patients to be inappropriate to participate in the trial determined by the investigator
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sung hwan Kim, MD, PhD
Phone
82-2-2258-6071
Email
sunghwan@catholic.ac.kr
Facility Information:
Facility Name
Seoul St. Mary's Hospital
City
Seoul
State/Province
Seocho-gu
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sung Hwan Kim, MD
Phone
82-2-2258-6071
Email
sunghwan@catholic.ac.kr
First Name & Middle Initial & Last Name & Degree
Ju Youn Kim, MD
First Name & Middle Initial & Last Name & Degree
Hwa Jung Kim, MD
Facility Name
Yeouido St. Mary's hospital
City
Yeongdeungpo-gu
State/Province
Seoul
ZIP/Postal Code
07345
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Kyoung Sa, MD
Facility Name
Bucheon St. Mary's hospital
City
Bucheon
ZIP/Postal Code
14647
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chan seok Park, MD
Facility Name
Daejeon St. Mary's hospital
City
Daejeon
ZIP/Postal Code
34943
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jung Sun Cho, MD
Facility Name
Incheon St. Mary's hospital
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mi Jung Kim, MD
Facility Name
St. Vincent hospital
City
Suwon
ZIP/Postal Code
16247
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
You Mi Hwang, MD
Facility Name
Uijeongbu St. Mary's Hospital
City
Uijeongbu
ZIP/Postal Code
11765
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hyo suk Ahn, MD

12. IPD Sharing Statement

Learn more about this trial

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

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