NCT04258488招募中4 期
Randomized, Evaluation of Long-term Anticoagulation With Oral Factor Xa Inhibitor Versus Vitamin K Antagonist After Mechanical Aortic Valve Replacement
Joon Bum Kim19 个研究点 分布在 1 个国家目标入组 1,300 人开始时间: 2022年2月21日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 1,300
- 试验地点
- 19
- 主要终点
- Number of participants with the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding
研究概览
简要总结
This study evaluates the long-term anticoagulation with oral factor Xa inhibitor versus vitamin K antagonist in patients receiving a mechanical aortic valve replacement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
- •aneurysms- cerebral, dissecting aorta
- •pericarditis and pericardial effusions
- •bacterial endocarditis
- •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
- •Switching anticoagulants
- •Intravenous UFH to keep central/arterial lines open
- •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
研究组 & 干预措施
Oral Factor Xa inhibitor
Experimental
干预措施: Rivaroxaban Oral Tablet (Drug)
Vitamin K antagonist
Active Comparator
干预措施: Vitamin K antagonist(warfarin) (Drug)
结局指标
主要结局
Number of participants with the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding
时间窗: 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.
The event rate of the composite of cardiac death, valve thrombosis, valve-related thromboembolic event, major bleeding, and clinically-relevant non-major bleeding
时间窗: 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.
次要结局
- Number of Participants With the composite of cardiac death, valve thrombosis and valve-related thromboembolic event(1 year)
- Number of Participants With the composite event of major bleeding and clinically-relevant non-major bleeding(1 year)
- Number of Participants With all cause death(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 myocardial infarction(1 year)
- Number of Participants With major bleeding(1 year)
- Number of Participants With transient ischemic attack(1 year)
- Number of Participants With stroke(1 year)
- Number of Participants With systemic embolism(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 Clinically-relevant non-major bleeding(1 year)
- Number of Participants With the composite of all-cause death, stroke, systemic embolism, transient ischemic attack and myocardial infarction event(1 year)
- Number of Participants With cardiovascular death(1 year)
- Number of Participants With valve-related thromboembolic(1 year)
- Number of Participants With the composite of stroke, systemic embolism, transient ischemic attack and myocardial infarction event(1 year)
- The change of echocardiographic parameter(1 year)
- 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)(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(1 year)
- The event rate of Clinically-relevant non-major bleeding(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(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)
研究者
Joon Bum Kim
Professor, Department of Thoracic and Cardiovascular Surgery, University of Ulsan College of Medicine
Asan Medical Center
研究点 (19)
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