Rivaroxaban Post-Transradial Access for the Prevention of Radial Artery Occlusion (CAPITAL-RAPTOR)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 700
- 试验地点
- 1
- 主要终点
- Primary Safety Outcome - Major Bleeding
研究概览
简要总结
Transradial access (TRA) is the preferred vascular access site for invasive coronary angiography. TRA is limited by blockage of the radial artery post-procedurally, preventing future use of TRA. This is referred to as radial artery occlusion (RAO) and occurs in ~5% of cases. While intraprocedural anticoagulation has been studied extensively to mitigate this complication, oral anticoagulation post-TRA has not. The investigators will assess the impact of a one-week course of rivaroxaban post-TRA to reduce the rate of ultrasound-defined RAO at 30 days.
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
- Single (Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Rivaroxaban Group
Subjects will receive rivaroxaban 15mg tablet to be taken orally once daily for 7 days following transradial access.
干预措施: Rivaroxaban (Drug)
结局指标
主要结局
Primary Safety Outcome - Major Bleeding
时间窗: 30 days
Number of subjects to experience major bleeding as defined by the International Society on Thrombosis and Haemostasis (ISTH)
Primary Efficacy Outcome - Radial Artery Occlusion
时间窗: 30 days
Number of subjects to have a radial artery occlusion (RAO) at 30 days post-transradial access (TRA) as determined by Doppler ultrasound assessment.
次要结局
- Myocardial infarction(30 days)
- Stroke (ischemic or uncertain)(30 days)
- BARC bleeding criteria(30 days)
- All-Cause Mortality(30 days)
- Bleeding requiring medical attention(30 days)
- GUSTO bleeding criteria(30 days)
- Stent thrombosis(30 days)
- Fatal bleeding(30 days)
- Symptomatic bleeding in a critical area or organ(30 days)
- Stroke (hemorrhagic)(30 days)
- TIMI bleeding criteria(30 days)
研究者
Trevor J. Simard
Principal Investigator
Mayo Clinic