NCT04501900尚未招募4 期
The Standard Versus Prolonged Dual Antiplatelet Therapy After the XINSORB Bioresorbable Scaffold Implantation Trial
Shanghai Zhongshan Hospital0 个研究点目标入组 2,106 人开始时间: 2020年10月最近更新:
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
- 2,106
- 主要终点
- MACE
研究概览
简要总结
The aim of the SPARTA trial is to clarify the impact of extending DAPT beyond 1 year after XINSORB BRS implantation by investigating the balance of risk and benefit in a broad population of treated patients.
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
- •Subjects with XINSORB BRS implantation, then treated with DAPT for 12 months
- •Written informed consent from the subjects
- •Qualified candidates for coronary bypass surgery
- •Lesions with reference vessel diameter 2.75 to 3.5 mm
排除标准
- •Age ≤ 18 years
- •Cardiogenetic shock
- •Chronic heart failure with a left ventricular ejection fraction ≤ 30%
- •Oral anticoagulation therapy
- •Known allergy or intolerance to the study medications
- •Malignancies and other comorbid conditions with a life expectancy less than 5 years
- •Subjects treated with both BRS and DES during the index procedure
- •Pregnant wowen
- •Planned staged PCI
- •Contemporaneous enrollment in a different clinical trial
- •Any revascularization within 1 year
- •Planned surgery necessitating discontinuation of antiplatelet therapy within 36 months after enrollment
- •Unprotected left main artery
- •Lesions located at the ostium of the main coronary artery
- •bifurcation lesions (Medina 1,1,1) planning to be treated with two stents strategy
研究组 & 干预措施
prolonged DAPT group
Active Comparator
干预措施: Clopidogrel (Drug)
结局指标
主要结局
MACE
时间窗: 3 years
The incidence of a composite endpoint, including all-cause death, any myocardial infarction (MI), and all revascularization
BARC type 3, 4, and 5 bleeding events
时间窗: 3 years
次要结局
未报告次要终点
研究者
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