Comparing Edoxaban and Warfarin for Atrial Fibrillation with Mitral Stenosis
A Randomized, Open, Phase 2 Study to Evaluate the Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
PHASE2 · Seoul St. Mary's Hospital · NCT05540587
This study is testing whether a new blood thinner called edoxaban works better and is safer than warfarin for people with atrial fibrillation and mitral valve stenosis.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 240 (estimated) |
| Ages | 19 Years to 79 Years |
| Sex | All |
| Sponsor | Seoul St. Mary's Hospital (other) |
| Locations | 7 sites (Seoul, Seocho-gu and 6 other locations) |
| Trial ID | NCT05540587 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the efficacy and safety of edoxaban compared to warfarin in patients with atrial fibrillation and moderate to severe mitral valve stenosis. It is a multicenter, randomized, open-label phase 2 trial where participants are assigned to either the edoxaban or warfarin group. The primary outcome measures include the incidence of stroke and systemic arterial thromboembolism, while major bleeding serves as the safety outcome. The study aims to provide insights into the effectiveness of non-vitamin K antagonist oral anticoagulants in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 80 with a diagnosis of atrial fibrillation and moderate to severe mitral valve stenosis.
Not a fit: Patients with transient atrial fibrillation due to reversible causes or those undergoing mechanical valve replacement may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a safer and more effective anticoagulation option for patients with atrial fibrillation and mitral stenosis.
How similar studies have performed: While the use of edoxaban in other populations has shown promise, this specific application in patients with mitral stenosis is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Seoul, Seocho-gu and 6 other locations
- Seoul St. Mary's Hospital — Seoul, Seocho-gu, South Korea (RECRUITING)
- Yeouido St. Mary's hospital — Yeongdeungpo-gu, Seoul, South Korea (RECRUITING)
- Bucheon St. Mary's hospital — Bucheon-si, South Korea (RECRUITING)
- Daejeon St. Mary's hospital — Daejeon, South Korea (RECRUITING)
- Incheon St. Mary's hospital — Incheon, South Korea (RECRUITING)
- St. Vincent hospital — Suwon, South Korea (RECRUITING)
- Uijeongbu St. Mary's Hospital — Uijeongbu-si, South Korea (RECRUITING)
Study contacts
- Study coordinator: Sung hwan Kim, MD, PhD
- Email: sunghwan@catholic.ac.kr
- Phone: 82-2-2258-6071
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mitral Valve Stenosis, Atrial Fibrillation, Stroke, Systemic Embolism, Edoxaban, Warfarin, Systemic embolism