Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement

Recruiting now · Phase 4

Conditions studied: AORTIC VALVE DISEASES, Thromboembolism

In brief

This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.

Key facts

Study ID

NCT04258488

Run by

Joon Bum Kim

People needed

1300

Starts

2022-02-21

Expected to finish

2028-12-30

Last updated by the study team

2026-07-06

Who can join

Age: 19 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 19 and more
• At least 3 months after mechanical aortic valve replacement
• 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
• Voluntarily participated in the written agreement

You may not qualify if…

• Old-generation mechanical valve
• History of mechanical valve implantation in the mitral valve, pulmonary valve, or tricuspid valve
• Valvular atrial fibrillation(atrial fibrillation with moderate or severe mitral stenosis)
• Moderate to severe mitral stenosis or regurgitation
• History of hemorrhagic stroke
• Clinically overt stroke within the last 3 months
• Renal failure(creatinine clearance <15mL/min) or on hemodialysis
• Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%
• Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy
• Clinically significant active bleeding
• Bleeding or hemorrhagic disorder
• The increased risk of bleeding due to the following reasons
• History of gastrointestinal ulcers or active ulcerations within the last 6 months
• History of intracranial or intracerebral hemorrhage within the last 6 months
• Spinal cord vascular abnormalities or intracerebral vascular abnormalities
• History of the brain, spinal cord, or ophthalmic surgery within the last 6 months
• History of the brain or spinal cord injury within the last 6 months
• History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months
• Esophageal varices
• Arteriovenous malformation
• Vascular aneurysms
• Malignant tumor with a high risk of bleeding
• Bleeding tendencies associated with overt bleeding of
• gastrointestinal, genitourinary, respiratory tract, or colorectal cancer
• cerebrovascular hemorrhage

Where it is running

• Pusan National University Yangsan Hospital — Yangsan, South Korea (enrolling)
• Dong-A University Hospital — Busan, South Korea (enrolling)
• Keimyung University Dongsan Hospital — Daegu, South Korea (enrolling)
• GangNeung Asan Hospital — Gangneung, South Korea (enrolling)
• Chonnam National University Hospital — Gwangju, South Korea (enrolling)
• Seoul National University Bundang Hospital — Seongnam, South Korea (enrolling)
• Asan Medical Center — Seoul, South Korea (enrolling)
• Korea University Anam Hospital — Seoul, South Korea (enrolling)
• Samsung Medical Center — Seoul, South Korea (enrolling)
• Seoul National University Hospital — Seoul, South Korea (enrolling)
• Ajou University Hospital — Suwon, South Korea (enrolling)
• Eulji University Uijeongbu Hospital — Uijeongbu-si, South Korea (enrolling)
• Buchen Sejong Hospital — Bucheon-si, South Korea (enrolling)
• Severance Hospital — Seoul, South Korea
• Ulsan University Hospital — Ulsan, South Korea
• St. Vincent's Hospital, Catholic University of Korea — Suwon, South Korea

Full record on ClinicalTrials.gov

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