Evaluate the Efficacy and Safety of Edoxaban in patients with Atrial fibrillation and Mitral stenosis
- Conditions
- Diseases of the circulatory system
Recruitment & Eligibility
- Status
- ot yet recruiting
- Sex
- All
- Target Recruitment
- 240
1. age 19 to 79
2. AF documented with ECG
3. screening echocardiogram : moderate to severe MS
(Valve area under 1.5 cm2)
4. Informed consent (+)
1. reversible cause of atrial fibrillation (hyperthyroidism, post operative state, infectious condition)
2. history of mechanical prosthetic heart valve
3. coagulopathy, advanced liver disease
4. high bleeding risk less than 1month before randomization
1) GI ulcer
2) malignant neoplasm with bleeding tendancy
3) brain, spinal injury
4) previous history of brain, spinal cord, ocular surgery
5) history of intracranial bleeding
6) esophageal varix
7) arteriovenous malformations
8) vascular aneurysms
5. Acute MI, stroke, acute coronary syndrome, or percutaneous coronary intervention within the previous 14 d
6. Severe renal insufficiency (calculated CrCl <15 mL/min)
7. severe hypertension
8. vitamin K deficiency
9. alcohol dependence or psycotic disorder
10. Preplanned invasive procedures or surgeries in which bleeding is anticipated during the study period
11. pulmonary thromboembolism
12. Women of childbearing potential including
13. any contraindication for anticoagulant agents
14. Subjects previously randomized in a study within 30 days
15. Any condition that, in the opinion of the investigator, would place the subject at increased risk of harm if he/she participated in the study
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Ischemic or hemorrhagic stroke or systemic embolism
- Secondary Outcome Measures
Name Time Method MACE, major bleeding, other bleeding