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This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oral Factor Xa inhibitor | Experimental |
| |
| Vitamin K antagonist | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rivaroxaban Oral Tablet | Drug | For 12months, Rivaroxaban oral tablet 20mg once daily For renal disorder subjects_creatinine clearance 15-49 mL/min, 15mg once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding | 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. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| The event rate of all cause death | 1 year | |
| The event rate of cardiovascular death | 1 year | |
| The event rate of valve thrombosis confirmed by transthoracic echocardiography, transesophageal echocardiography, cine fluoroscopy, computed tomography, or autopsy (Valve Academic Research Consortium (VARC ) criteria) |
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Inclusion Criteria:
Age 19 and more
At least 3 months after mechanical aortic valve replacement
At least one of the conditions(as defined below) is met
Voluntarily participated in the written agreement
Exclusion Criteria:
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
Bleeding tendencies associated with overt bleeding of
Hemodynamically unstable or pulmonary embolism required thrombolysis or embolectomy
Combination therapy with other anticoagulants(Unfractionated heparin(UFH), enoxaparin, dalteparin, fondaparinux, etc.) However, the following cases are permitted
Uncontrolled moderate or severe hypertension
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
Infective endocarditis
Hypersensitivity to the main component or constituents of Rivaroxaban or Vitamin K antagonist
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
A genetic problem with galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
The unsuitable condition of the protocol
Actively participating in another drug or device investigational study, which has not completed the primary endpoint follow-up period
Terminal illness with life expectancy <12 months
Vitamin K deficiency
Alcoholic or psychical disorder
Threatened abortion, eclampsia, or preeclampsia
Concomitant use with antiplatelet in patients with a history of stroke or transient ischemic attack for the treatment of the acute coronary syndrome
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jung-hee Ham, RN | Contact | 82230104728 | cvcrc5@amc.seoul.kr |
| Name | Affiliation | Role |
|---|---|---|
| Jung-min Ahn, MD | drjmahn@gmail.com | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Buchen Sejong Hospital | Recruiting | Bucheon-si | South Korea |
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| Vitamin K antagonist(warfarin) | Drug | For 12months, keep the international normalized ratio (INR) 1.7-3.0 |
|
| 1 year |
| The event rate of valve-related thromboembolic event | 1 year |
| The event rate of transient ischemic attack | 1 year |
| The event rate of stroke | 1 year |
| The event rate of systemic embolism | 1 year |
| The event rate of myocardial infarction | 1 year |
| The event rate of major bleeding | BARC (Bleeding Academic Research Consortium) 3 or 5 | 1 year |
| The event rate of Clinically-relevant non-major bleeding | BARC (Bleeding Academic Research Consortium) 2 | 1 year |
| The event rate of the composite of cardiac death, valve thrombosis and valve-related thromboembolic event | 1 year |
| The event rate of the composite of cardiac death, valve thrombosis, stroke, systemic embolism and myocardial infarction event | 1 year |
| The event rate of the composite event of major bleeding and clinically-relevant non-major bleeding | 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. | 1 year |
| The event rate of the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event | 1 year |
| The event rate of the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event | 1 year |
| The change of echocardiographic parameter | Integral ratio at baseline and 1 year follow-up : transaortic valve mean gradient | 1 year |
| The change of echocardiographic parameter | Integral ratio at baseline and 1 year follow-up : transaortic valve peak gradient | 1 year |
| The change of echocardiographic parameter | Integral ratio at baseline and 1 year follow-up : transaortic valve peak velocity | 1 year |
| The change of echocardiographic parameter | Integral ratio at baseline and 1 year follow-up : effective orifice area(EOA) | 1 year |
| Dong-A University Hospital | Recruiting | Busan | South Korea |
|
| Keimyung University Dongsan Hospital | Recruiting | Daegu | South Korea |
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| GangNeung Asan Hospital | Recruiting | Gangneung | South Korea |
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| Chonnam National University Hospital | Recruiting | Gwangju | South Korea |
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| Seoul National University Bundang Hospital | Recruiting | Seongnam | South Korea |
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| Asan Medical Center | Recruiting | Seoul | 138-736 | South Korea |
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| Korea University Anam Hospital | Recruiting | Seoul | South Korea |
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| Samsung Medical Center | Recruiting | Seoul | South Korea |
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| Seoul National University Hospital | Recruiting | Seoul | South Korea |
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| Severance Hospital | Not yet recruiting | Seoul | South Korea |
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| Ajou University Hospital | Recruiting | Suwon | South Korea |
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| St. Vincent's Hospital, Catholic University of Korea | Not yet recruiting | Suwon | South Korea |
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| Eulji University Uijeongbu Hospital | Recruiting | Uijeongbu-si | South Korea |
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| Ulsan University Hospital | Not yet recruiting | Ulsan | South Korea |
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| Pusan National University Yangsan Hospital | Recruiting | Yangsan | South Korea |
|
| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D013923 | Thromboembolism |
| ID | Term |
|---|---|
| D006349 | Heart Valve Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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