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

Launched by JOON BUM KIM · Feb 4, 2020

Keywords

ClinConnect Summary

This clinical trial is investigating two types of blood-thinning medications, known as anticoagulants, to see which is better for patients who have received a mechanical aortic valve replacement. Specifically, the study is comparing an oral medication called a factor Xa inhibitor to a traditional medication called a vitamin K antagonist. The goal is to determine which medication provides better long-term protection against blood clots for patients with a mechanical heart valve.

To participate in this study, individuals must be at least 19 years old and have had their mechanical aortic valve replacement at least three months prior. They should also have good heart function, as defined by specific criteria, and must agree to participate voluntarily. Participants will undergo regular check-ups and monitoring to ensure their safety while taking one of the two medications. It's important to note that certain health conditions, like severe bleeding risks or recent strokes, may prevent someone from joining the trial. Overall, this study aims to help doctors make better treatment decisions for patients with mechanical heart valves in the future.

Gender

ALL

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 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