A Phase 2, Randomized, Open Label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban Compared With Vitamin K Antagonism in Patients With Atrial Fibrillation With Bioprosthetic Mitral Valves - RIVER
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 1,005
- 试验地点
- 1
- 主要终点
- Major Clinical Events
研究概览
简要总结
RIvaroxaban for Valvular heart diseasE and atRial fibrillation trial (RIVER trial).
详细描述
A Phase 2, Randomized, Open label, Non-Inferiority Clinical Trial to Explore the Safety and Efficacy of Rivaroxaban compared with vitamin K antagonism in Patients with Atrial Fibrillation with Bioprosthetic Mitral valves - RIVER. Main analysis for the primary endpoint are based on the Restricted Mean Survival Time (RMST) method.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients aged >18 years at time of inclusion
- •Patients with Persistent or paroxysmal Atrial Fibrillation or flutter with bioprosthetic mitral valves.
- •The patient must be able to give informed consent
排除标准
- •Cardiovascular-related conditions as known presence of cardiac thrombus or tumor
- •Active endocarditis
- •Uncontrolled hypertension
- •Hemorrhage risk-related criteria
- •Active internal bleeding
- •History of, or condition associated with, increased bleeding risk
- •Concomitant conditions and therapies
- •History of previous thromboembolism with high risk of bleeding:
- •Severe, disabling stroke (modified Rankin score of 4-5, inclusive) within 3 months
- •Acute thromboembolic events or thrombosis (venous/arterial) within the last 14 days prior to randomization
- •Acute MI within the last 14 days prior to randomization
- •Treatment with: Chronic aspirin therapy > 100 mg daily or dual antiplatelet therapy; Intravenous antiplatelets; Fibrinolytics; Anticipated need for long-term treatment with a nonsteroidal antiinflammatory drug; Systemic treatment with a strong inhibitor of cytochrome P450 3A4, such as ketoconazole or protease inhibitors; Treatment with a strong inducer of cytochrome P450 3A4, such as rifampicin, phenytoin, phenobarbital, or carbamazepine.
- •Pregnancy or breastfeeding or women of reproductive age not using effective contraceptive methods
- •Calculated creatinine clearance bellow 30 mL/min
- •Known significant liver disease or alanine aminotransferase N3× the upper limit of normal
- •Previous participation in this study.
研究组 & 干预措施
Rivaroxaban 20mg
Oral Rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.
干预措施: Rivaroxaban (Drug)
Rivaroxaban 20mg
Oral Rivaroxaban, 20 mg od. Patients with a calculated creatinine clearance of 30 to 49 mL/min per 1.73 m2 received a reduced dose of rivaroxaban of 15 mg od.
干预措施: Warfarin (Drug)
Warfarin
Warfarin Warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.
干预措施: Rivaroxaban (Drug)
Warfarin
Warfarin Warfarin once daily (q.d.). The individual doses will be titrated as needed to maintain a target INR of 2.0-3.0.
干预措施: Warfarin (Drug)
结局指标
主要结局
Major Clinical Events
时间窗: 12 months
Combined Endpoint of major clinical events as defined by strokes (CVA), transient ischemic attack (TIA), major bleeding, all-cause death, valve thrombosis and non-CNS systemic embolism, hospitalization due to cardiac failure.
次要结局
- Combined endpoint of nonfatal stroke (CVA), transient ischemic attack (TIA), systemic embolism, valve thrombosis, venous thromboembolism and vascular causes death.thrombosis, and vascular death(12 months)
- Major bleeding(12 months)