Short-term Dual Antiplatelet Therapy After Deployment of Bioabsorbable Polymer Everolimus-eluting Stent
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,452
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular clinical events (MACCE)
研究概览
简要总结
To compare the clinical outcomes of P2Y12 antagonist monotherapy with aspirin plus P2Y12 antagonist following 3-month of DAPT in patients undergoing PCI with bioabsorbable polymer Everolimus-eluting stents (Synergy®)
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
- 19 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients treated with a new generation of Evelorimus-eluting stents (Synergy®)
- •Patients who understand the content of the subject description and voluntarily sign the subject
排除标准
- •Hemodynamically unstable patient
- •Severe hypersensitivity reactions to aspirin, clopidogrel, ticagrelor, everolimus, contrast agent
- •Patients at high risk of bleeding, anemia, thrombocytopenia
- •Patients requiring oral anticoagulants
- •Pregnant women or women of childbearing age
- •Life expectancy is less than one year
- •Patients receiving a potent CYP3A4 inhibitor (eg, ketoconazole, clarithromycin, napjodone, ritonavir, atazanavir)
- •Patients with a history of intracranial hemorrhage
- •Patients with moderate to severe hepatic impairment
- •Patients underwent coronary intervention with stenting within 1 year
- •Patients with left-main lesions requiring coronary intervention
- •Patients with chronic stricture lesions requiring treatment
- •Patients with in-stent restenosis in a lesion requiring treatment
- •Patients with bifurcation lesions requiring stenting in lateral branches
- •Patients with lesions requiring more than 3 stents
研究组 & 干预措施
P2Y12 antagonist monotherapy
P2Y12 antagonist monotherapy after 3-month DAPT
干预措施: P2Y12 antagonist monotherapy (Drug)
Aspirin + P2Y12 antagonist
Aspirin + P2Y12 antagonist after 3-month DAPT
干预措施: Aspirin plus P2Y12 antagonist (Drug)
结局指标
主要结局
Major adverse cardiovascular clinical events (MACCE)
时间窗: between 3 and 12 month after the procedure
cardiovascular-related death, myocardial infarction, stent thrombosis, stroke, or target lesion revascularization
Major bleeding
时间窗: between 3 and 12 month after the procedure
The Bleeding Academic Research Consortium (BARC) type 3 or 5
次要结局
未报告次要终点
研究者
Bumkee Hong
Professor
Gangnam Severance Hospital