NCT02837003Unknown不适用
3-Month Discontinuation of Dual Antiplatelet Therapy After Ultimaster Sirolimus-Eluting Stent Implantation
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
研究概览
简要总结
To evaluate safety of reduction of dual antiplatelet therapy period to three months after implantation of Ultimaster sirolimus-eluting stent (U-SES).
Additionally to investigate appropriateness of thienopyridine monotherapy with discontinuation of aspirin.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with coronary artery lesion who received percutaneous coronary intervention using Ultimaster sirolimus-eluting stent.
- •Patients considered appropriate to discontinue dual antiplatelet therapy at 3 months after stent implantation.
- •Patients who have provided written informed consent.
排除标准
- •Patients previously experienced stent thrombosis.
- •Patients who are unable to clinical follow-up procedure specified in the protocal for the present study.
- •Patients who are enrolled or planned to participate in another clinical trials of antiplatelet therapy.
研究组 & 干预措施
Experimental: Aspirin
Aspirin treatment for 3 months after the Ultimaster sirolimus-eluting stent implantation.
干预措施: Aspirin (Drug)
Experimental: Thienopyridine
Thienopyridine treatment for 3 months after the Ultimaster sirolimus-eluting Stent implantation.
干预措施: Thienopyridine (Drug)
结局指标
主要结局
Composite endpoint of all cause death in 12 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).
时间窗: 12-month
次要结局
- Bleeding complications (BARC definition)(12-month)
- Composite endpoint of all cause death in 3 months, myocardial infarction, stroke (ischemic and hemorrhagic), ARC definite/probable stent thrombosis and serious bleeding (BARC 3 or 5).(3-month)
- Major adverse cardiac event(12-month)
- All cause death(12-month)
- Cardiac death(12-month)
- Myocardial infarction(12-month)
- Stroke (ischemic and hemorrhagic)(12-month)
- Target lesion revascularization(12-month)
- Target vessel revascularization(12-month)
- Readmission related to angina(12-month)
- Stent thrombosis(3-month)
- Stent thrombosis (ARC definition)(12-month)
- Comparison of event rate by the type of antiplatelet agent(12-month)
研究者
研究点 (1)
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