None listed
Conditions
Interventions
Drug : Edoxaban 60mg (dose reduction criteria - 30mg), q day, oral
warfarin, target INR 2-3, q day, oral
randomized control
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 (+)
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ischemic or hemorrhagic stroke or systemic embolism | — |
Secondary
| Measure | Time frame |
|---|---|
| MACE, major bleeding, other bleeding | — |
Countries
Korea, Republic of
Contacts
Public ContactJu Yeon Kim
Samsung Medical Center
Outcome results
None listed