AORTIC VALVE DISEASES, Thromboembolism
Conditions
Keywords
Aortic valve replacement, Mechanical valve
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.
Interventions
For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects\_creatinine clearance 15-49 mL/min, 15mg once daily
For 12months, keep the international normalized ratio (INR) 1.7-3.0
Sponsors
Joon Bum Kim
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding | 1 year | A composite endpoint is an endpoint that is a combination of multiple clinical endpoints. An event that is considered to have occurred if any one of several different events is observed. Clinically-relevant non-major bleeding is defined as BARC(Bleeding Academic Research Consortium) 2 Bleeding and major Bleeding is defined as BARC(Bleeding Academic Research Consortium) 3 or 5 Bleeding. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With major bleeding | 1 year | BARC (Bleeding Academic Research Consortium) 3 or 5 |
| Number of Participants With Clinically-relevant non-major bleeding | 1 year | BARC (Bleeding Academic Research Consortium) 2 |
| Number of Participants With the composite of cardiac death, valve thrombosis and valve-related thromboembolic event | 1 year | — |
| Number of Participants With valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria) | 1 year | — |
| Number of Participants With valve-related thromboembolic | 1 year | — |
| Number of Participants With transient ischemic attack | 1 year | — |
| Number of Participants With stroke | 1 year | — |
| Number of Participants With myocardial infarction | 1 year | — |
| Number of Participants With all cause death | 1 year | — |
| Number of Participants With cardiovascular death | 1 year | — |
| Number of Participants With the composite of cardiac death, valve thrombosis, stroke, systemic embolism and myocardial infarction event | 1 year | — |
| Number of Participants With the composite event of major bleeding and clinically-relevant non-major bleeding | 1 year | Clinically-relevant non-major bleeding is defined as BARC (Bleeding Academic Research Consortium) 2 Bleeding and major Bleeding is defined as BARC (Bleeding Academic Research Consortium) 3 or 5 Bleeding. |
| Number of Participants With the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event | 1 year | — |
| Number of Participants With the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event | 1 year | — |
| The change of echocardiographic parameter | 1 year | Integral ratio at baseline and 1 year follow-up : transaortic valve mean gradient |
| Number of Participants With systemic embolism | 1 year | — |
Countries
South Korea
Contacts
Primary ContactJung-hee Ham, RN
Outcome results
None listed