Actively Recruiting
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Led by Sung-Hwan Kim · Updated on 2022-09-14
240
Participants Needed
7
Research Sites
208 weeks
Total Duration
On this page
Sponsors
S
Sung-Hwan Kim
Lead Sponsor
D
Daiichi Sankyo Korea Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years
- Diagnosed atrial fibrillation by ECG at any time before enrollment
- Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time before enrollment
You will not qualify if you...
- Refusal to provide consent
- Transient atrial fibrillation due to reversible causes like postoperative state, ongoing systemic inflammation, or thyrotoxicosis
- History of mechanical valve replacement
- Known coagulopathy
- Significant liver impairment increasing bleeding risk
- High bleeding risk conditions diagnosed within 1 month before randomization, including gastrointestinal ulcers or bleeding, esophageal or gastric varices, malignancy, brain or spinal cord injury, brain surgery, intracranial hemorrhage, vascular malformations or aneurysms
- Stroke, systemic arterial thromboembolism, or acute myocardial infarction diagnosed within 14 days before randomization
- End-stage kidney disease with creatinine clearance below 15 mL/min or on dialysis
- Severe hypertension
- Alcohol abuse or other psychiatric disorders
- Epidural puncture or anesthesia
- Pulmonary thromboembolism with hemodynamic instability requiring thrombolysis or thrombectomy
- Pregnant or lactating women
- Allergy to edoxaban or warfarin
- Ongoing need for other anticoagulants or certain antibiotics like clarithromycin or rifampin
- Participation in other clinical trials within 1 month before enrollment
- Any condition judged by the investigator to make participation inappropriate
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 7 locations
1
Seoul St. Mary's Hospital
Seoul, Seocho-gu, South Korea, 06591
Actively Recruiting
2
Yeouido St. Mary's hospital
Yeongdeungpo-gu, Seoul, South Korea, 07345
Actively Recruiting
3
Bucheon St. Mary's hospital
Bucheon-si, South Korea, 14647
Actively Recruiting
4
Daejeon St. Mary's hospital
Daejeon, South Korea, 34943
Actively Recruiting
5
Incheon St. Mary's hospital
Incheon, South Korea, 21431
Actively Recruiting
6
St. Vincent hospital
Suwon, South Korea, 16247
Actively Recruiting
7
Uijeongbu St. Mary's Hospital
Uijeongbu-si, South Korea, 11765
Actively Recruiting
Research Team
S
Sung hwan Kim, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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