Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
NCT ID: NCT04258488
Last Updated: 2025-12-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
1300 participants
INTERVENTIONAL
2022-02-21
2028-12-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Oral Factor Xa inhibitor
Rivaroxaban Oral Tablet
For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily
Vitamin K antagonist
Vitamin K antagonist(warfarin)
For 12months, keep the international normalized ratio (INR) 1.7-3.0
Interventions
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Rivaroxaban Oral Tablet
For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily
Vitamin K antagonist(warfarin)
For 12months, keep the international normalized ratio (INR) 1.7-3.0
Eligibility Criteria
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Inclusion Criteria
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
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 hemodialysis
8. Left ventricular dysfunction: Left ventricular ejection fraction (LVEF) ≤40%
9. Child-Pugh B and C hepatic impairment or any hepatic disease associated with coagulopathy
10. Clinically significant active bleeding
11. Bleeding or hemorrhagic disorder
12. The increased risk of bleeding due to the following reasons
1. History of gastrointestinal ulcers or active ulcerations within the last 6 months
2. History of intracranial or intracerebral hemorrhage within the last 6 months
3. Spinal cord vascular abnormalities or intracerebral vascular abnormalities
4. History of the brain, spinal cord, or ophthalmic surgery within the last 6 months
5. History of the brain or spinal cord injury within the last 6 months
6. History of the brain or spinal cord injury or spinal tap, major regional anesthesia, or spinal anesthesia within the last 6 months
7. Esophageal varices
8. Arteriovenous malformation
9. Vascular aneurysms
10. Malignant tumor with a high risk of bleeding
13. Bleeding tendencies associated with overt bleeding of
1. gastrointestinal, genitourinary, respiratory tract, or colorectal cancer
2. cerebrovascular hemorrhage
3. aneurysms- cerebral, dissecting aorta
4. pericarditis and pericardial effusions
5. bacterial endocarditis
14. Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy
15. Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted
* Switching anticoagulants
* Intravenous UFH to keep central/arterial lines open
16. Uncontrolled moderate or severe hypertension
17. Anemia at least one among the conditions(as defined below) is met 1) Hemoglobin level \<10.0 g/dL or platelet count \< 100 x 10x9/L within the last 6 months 2) Diagnosed and documented ongoing anemia
18. Infective endocarditis
19. Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist
20. Positive pregnancy test results (all pregnant women should undergo urinary human chorionic gonadotropin (hCG) testing within 7 days before screening and/or randomization) or during pregnancy or lactation
21. A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
22. The unsuitable condition of the protocol
23. Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period
24. Terminal illness with life expectancy \<12 months
25. Vitamin K deficiency
26. Alcoholic or psychical disorder
27. Threatened abortion, eclampsia, or preeclampsia
28. Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome
19 Years
ALL
No
Sponsors
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Joon Bum Kim
OTHER
Responsible Party
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Joon Bum Kim
Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine
Principal Investigators
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Locations
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Buchen Sejong Hospital
Bucheon-si, , South Korea
Seoul National University Bundang Hospital
Bundang, , South Korea
Dong-A University Hospital
Busan, , South Korea
Keimyung University Dongsan Hospital
Daegu, , South Korea
GangNeung Asan Hospital
Gangneung, , South Korea
Chonnam National University Hospital
Gwangju, , South Korea
Asan Medical Center
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Samsung Medical Center
Seoul, , South Korea
Seoul National University Hospital
Seoul, , South Korea
Ajou University Hospital
Suwon, , South Korea
St. Vincent's Hospital, Catholic University of Korea
Suwon, , South Korea
Eulji University Uijeongbu Hospital
Uijeongbu-si, , South Korea
Ulsan University Hospital
Ulsan, , South Korea
Pusan National University Yangsan Hospital
Yangsan, , South Korea
Countries
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Central Contacts
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Facility Contacts
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Hee-moon Lee, MD
Role: primary
Hyung Gon Je, MD
Role: primary
Yong-rak Cho, MD
Role: primary
Yoon-suk Kim, MD
Role: primary
Hanbit Park
Role: primary
Kyo-sun Lee, MD
Role: primary
Joon-bum Kim, MD
Role: primary
Ho-Sung Son, MD
Role: primary
Dong-sub Jung, MD
Role: primary
Jae-woong Choi, MD
Role: primary
Soo Jin Park, MD
Role: primary
Jin Won Shin, MD
Role: primary
Joon Lee
Role: primary
Kwan-sik Kim, MD
Role: primary
mi-hee Lim, MD
Role: primary
Other Identifiers
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AMCCV2020-01
Identifier Type: -
Identifier Source: org_study_id