NCT04258488 Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
| NCT ID | NCT04258488 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Joon Bum Kim |
| Condition | AORTIC VALVE DISEASES |
| Study Type | INTERVENTIONAL |
| Enrollment | 1,300 participants |
| Start Date | 2022-02-21 |
| Primary Completion | 2027-12-31 |
Trial Parameters
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Brief Summary
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
Eligibility Criteria
Inclusion Criteria: 1. Age 19 and more 2. At least 3 months after mechanical aortic valve replacement 3. At least one of the conditions(as defined below) is met * The New York Heart Association (NYHA) Functional Classification I or II; or * According to the Valve Academic Research Consortium(VARC)2 criteria, confirmed proper valve function: no prosthesis-patient mismatch and mean aortic valve gradient \<20 mm Hg or peak velocity \<3 m/s, AND no moderate or severe prosthetic valve regurgitation 4. Voluntarily participated in the written agreement Exclusion Criteria: 1. Old-generation mechanical valve 2. History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve 3. Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis) 4. Moderate to severe mitral stenosis or regurgitation 5. History of hemorrhagic stroke 6. Clinically overt stroke within the last 3 months 7. Renal failure(creatinine clearance \<15mL/min) or on hem