NCT06108414尚未招募4 期
The Efficacy and Safety of Low-dose Versus Standard-dose Rivaroxaban in Elderly Patients With Atrial Fibrillation
China National Center for Cardiovascular Diseases1 个研究点 分布在 1 个国家目标入组 4,374 人开始时间: 2024年8月1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
- 尚未招募
- 发起方
- 入组人数
- 4,374
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular and cerebrovascular events(MACCE)
研究概览
简要总结
To evaluate the efficacy and safety of low-dose versus standard-dose rivaroxaban anticoagulation therapy in elderly patients with atrial fibrillation.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Low-dose rivaroxaban
Experimental
15mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the low-dose group, the dose was reduced from the usual 15mg q.d. to 10mg q.d. .
干预措施: low-dose rivaroxaban (Drug)
Standard-dose rivaroxaban
Active Comparator
20mg q.d. rivaroxaban for 2 years after randomization. The dose should be reduced in the following special conditions: 1. Creatinine clearance <50 mL/min; 2. Body weight ≤60kg; 3. Age ≥80 years old. In the standard-dose group, the dose was reduced from the 20mg q.d. to 15mg q.d. .
干预措施: Standard-dose rivaroxaban (Drug)
结局指标
主要结局
Major adverse cardiovascular and cerebrovascular events(MACCE)
时间窗: Through study completion, an estimated average of 2 years
A composite endpoint of clinical events including cardiovascular death, myocardial infarction, stroke, and systemic embolism was firstly recorded after randomization
次要结局
- Bleeding events(Through study completion, an estimated average of 2 years)
- Net clinical benefit(Through study completion, an estimated average of 2 years)
- Components of all primary and secondary outcome measures(Through study completion, an estimated average of 2 years)
研究者
研究点 (1)
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