Efficacy and Safety of Rivaroxaban in the Early Postoperative Period for Patients With Bioprosthetic Valves: A Prospective, Randomized, Controlled Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 250
- 主要终点
- all-cause death
研究概览
简要总结
this study aims to comprehensively evaluate the efficacy and safety profiles of rivaroxaban and warfarin during the initial postoperative period following surgical bioprosthetic valve in patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 80 years
- •Patients who underwent successful surgical bioprosthetic valve replacement or repair to either the mitral, aortic position or both
- •Signed informed consent
排除标准
- •Aged below 18 or over 80 years
- •Mechanical heart valves (MHV)
- •Bioprosthetic valve transcatheter valve replacement (TAVR)
- •Hemorrhage risk-related criteria
- •Active internal bleeding
- •Major surgical procedure or trauma within 30 days before the randomization visit
- •History of intracranial, intraocular, spinal, gastrointestinal, or atraumatic intra-articular bleeding
- •Chronic hemorrhagic disorder
- •Planned invasive procedure with potential for uncontrolled bleeding, including major surgery
- •Concomitant conditions and therapies
- •Clinically overt stroke within the past 3 months
- •Major surgery within 1 month
- •Acute coronary syndrome within 1 month
- •Active infective endocarditis
- •Severe hepatic impairment、hepatic disease associated with coagulopathy or Moderate and severe hepatic impairment (Child-Pugh Class B or C)
- •Uncontrolled severe hypertension
- •Active malignancy
- •Medication-related
- •Hypersensitivity or contraindications to Rivaroxaban, VKA, heparin.
- •Concomitant treatment with strong inhibitors of both CYP3A4 and P-gp (e.g., azole antifungals, such as ketoconazole and itraconazole, or HIV protease inhibitors, such as ritonavir)
- •Concomitant treatment with strong inducers of CYP3A4 (e.g., carbamazepine, phenytoin, rifampin, etc.)
- •HAS-BLED score>3
- •Abnormal local laboratory results, such as Platelet count < 50 x109/L、Hemoglobin < 8 g/dL (5 mmol/L)
- •Female subjects of childbearing potential without using adequate contraception、
- •Female pregnant or breast-feeding
- •Participation is not likely to comply with the study procedures or will complete follow-up
- •Participation in another clinical trial that potentially interferes with the current study
- •Life expectancy less than 6 months beyond the targeted last visit
研究组 & 干预措施
rivaroxaban group
Patients allocated to the rivaroxaban group will be administered a dose of 20 mg orally once daily (to be taken with food), or 15 mg once daily in patients with moderate renal impairment at screening (defined as creatinine clearance rate, CrCl between 30 and 49 mL/min).
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
all-cause death
时间窗: 0.5, 1, 3, and 6 months
Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization.
Major cardiovascular events (stroke, transient ischemic attack (TIA), valve thrombosis, systemic embolism not related to the central nervous system (CNS), hospitalization due to heart failure)
时间窗: 0.5, 1, 3, and 6 months
Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization.
Major bleeding
时间窗: 0.5, 1, 3, and 6 months
Patients will be scheduled for outpatient clinic or phone visits at intervals of 0.5, 1, 3, and 6 months following enrollment. During these visits, patients will be instructed to document any symptoms indicative of clinical thromboembolic or bleeding events. If such symptoms are reported, patients may undergo necessary diagnostic and laboratory testing. Cardiac CT and transthoracic echocardiography will be conducted at the 3-month and 6-month marks post-randomization.
次要结局
- Major bleeding events and clinically relevant non-major (CRNM) bleeding events and minor bleeding events(0.5, 1, 3, and 6 months)
- Thromboembolic events (stroke, TIA, deep venous thrombosis, pulmonary embolism, non-CNS systemic embolism, valve thrombosis).(0.5, 1, 3, and 6 months)
- Cardiovascular causes death(0.5, 1, 3, and 6 months)