Mitral Valve StenosisPhase 2ERTEMISNCT05540587
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
A Phase 2 study testing Edoxaban and Warfarin in people with Mitral Valve Stenosis and Atrial Fibrillation, run by Sung-Hwan Kim at 7 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 to 79 years
- Conditions the study is for
- Mitral Valve Stenosis, Atrial Fibrillation, Stroke
- What is being tested?
- Edoxaban and Warfarin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 20 May 2022to 20 May 2026
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites, 7 recruiting
- Recruiting
Bucheon St. Mary's hospital
Bucheon-si, 14647
Chan seok Park, MD
- Recruiting
Daejeon St. Mary's hospital
Daejeon, 34943
Jung Sun Cho, MD
- Recruiting
Incheon St. Mary's hospital
Incheon, 21431
Mi Jung Kim, MD
- Recruiting
Seoul St. Mary's Hospital
Seoul, Seocho-gu, 06591
Sung Hwan Kim, MD, 82-2-2258-6071, sunghwan@catholic.ac.kr
Ju Youn Kim, MD
- Recruiting
St. Vincent hospital
Suwon, 16247
You Mi Hwang, MD
- Recruiting
Uijeongbu St. Mary's Hospital
Uijeongbu-si, 11765
Hyo suk Ahn, MD
- Recruiting
Yeouido St. Mary's hospital
Yeongdeungpo-gu, Seoul, 07345
Young Kyoung Sa, MD
About this study
Official title: A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
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.
Read the 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.
- Conditions
- Mitral Valve Stenosis, Atrial Fibrillation, Stroke, Systemic Embolism
- Being tested
- Edoxaban, Warfarin
- Keywords
- Edoxaban, Warfarin, Stroke, Systemic embolism, Mitral Valve Stenosis, Atrial Fibrillation
- Medical subject headings
- Mitral Valve Stenosis, Atrial Fibrillation, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EdoxabanDrug
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)
WarfarinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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. Receives: Drug: Warfarin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 15 days after randomization
Secondary outcomes (3)
Stroke
The number of patients with the first occurrence of a stroke during the study period
Measured: 15 days after randomization
Systemic embolism
The number of patients with the first occurrence of a systemic embolism during the study period
Measured: 15 days after randomization
Death from any cause
The number of patients who died for any reason during the study period
Measured: 15 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2022
- Study start20 May 2022
- Primary completion20 May 2024 (estimated)
- Study completion20 May 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sung-Hwan Kim
- Sponsor type
- University, hospital or other
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Responsible party
- Sponsor-investigator, Sung-Hwan Kim, Seoul St. Mary's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05540587
- Sponsor's protocol ID
- KC21MIDS0296
- Acronym
- ERTEMIS
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 14 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
- ClinicalTrials.gov ID
- NCT05540587
- Acronym / sponsor ID
- ERTEMIS / KC21MIDS0296
- Conditions
- Mitral Valve Stenosis, Atrial Fibrillation, Stroke, Systemic Embolism
- Keywords
- Edoxaban, Warfarin, Stroke, Systemic embolism, Mitral Valve Stenosis, Atrial Fibrillation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- Sung-Hwan KimUniversity, hospital or other
- Collaborators
- Daiichi Sankyo Korea Co., Ltd.
- Study start
- 20 May 2022 (actual)
- Primary completion
- 20 May 2024 (estimated)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 14 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Edoxaban | Experimental | Drug: EdoxabanPatients 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 | Active comparator | Drug: WarfarinPatients 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. |
Who may qualify
- Ages
- 19 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
Key exclusion criteria (18 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EdoxabanPatients 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 |
| WarfarinPatients 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 |
Primary outcome
Composite of Stroke or Systemic arterial thromboembolism
Time frame: 15 days after randomization
The number of patients with the first occurrence of a stroke or systemic embolism during the study period
3 secondary outcomes
Stroke
Time frame: 15 days after randomization
Systemic embolism
Time frame: 15 days after randomization
Death from any cause
Time frame: 15 days after randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Edoxaban and Warfarin in people with Mitral Valve Stenosis and Atrial Fibrillation, run by Sung-Hwan Kim at 7 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sung hwan Kim, MD, PhD (82-2-2258-6071, sunghwan@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite of Stroke or Systemic arterial thromboembolism (time frame: 15 days after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2022.