Optimized Duration of Clopidogrel Therapy Following Treatment With the Endeavor Zotarolimus - Eluting Stent in the Real World Clinical Practice - Optimize Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,119
- 试验地点
- 32
- 主要终点
- NACCE
研究概览
简要总结
Prospective, multicenter, randomized (two-arm 1:1), non-inferiority clinical evaluation comparing 2 regimes of dual antiplatelet therapy (DAPT) with aspirin + clopidogrel following percutaneous coronary intervention (PCI) with Endeavor Zotarolimus eluting stent (ZES) to evaluate the impact of different regimes of DAPT on clinical outcomes in minimally selected patients from the "real-world" clinical practice receiving the Endeavor ZES for the treatment of coronary artery lesions. Patients undergoing percutaneous treatment with the Endeavor ZES will be randomized in a 1:1 ratio to 2 regimens of DAPT including oral clopidogrel 75mg/day for 3 months versus 12 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •patients >18 years of age,
- •clinical indication for PCI with stent implantation of at least one angiographically documented coronary artery lesion,
- •agreement to undergo all protocol clinical follow-ups. 4 - presence of at least one obstruction >50% diameter stenosis by visual estimation in a major epicardial vessel or a major branch (≥2.50mm), with coronary anatomy suitable for percutaneous treatment with implantation of the Endeavor ZES.
排除标准
- •ST-elevation acute MI presenting for primary or rescue PCI;
- •DES in-stent restenosis;
- •PCI with bare metal stents <6 months prior to index procedure;
- •previous treatment with any DES;
- •scheduled elective surgery within 12 months post index procedure;
- •contra-indication, intolerance, or known hypersensibility to aspirin and/or clopidogrel;
- •known illness with life expectancy <36 months; and impossibility to comply with all protocol follow-ups.
- •target lesion(s) located in saphenous vein grafts,
- •coronary anatomy unsuitable for percutaneous treatment with implantation of the Endeavor ZES.
研究组 & 干预措施
Clopidogrel 3 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 3 months.
干预措施: Clopidogrel (Drug)
Clopidogrel 12 months
Regime of dual antiplatelet therapy (DAPT) including aspirin+clopidogrel for 12 months.
干预措施: Clopidogrel (Drug)
结局指标
主要结局
NACCE
时间窗: 12 months clinical follow-up
rates of Net Clinical Benefit (net adverse clinical and cerebral events, NACCE) at 12 months clinical follow-up. The primary endpoint is defined as the composite endpoint of: death by any cause, myocardial infarction (MI), cerebral vascular accident, and major bleeding (according to the modified REPLACE-2 and GUSTO criteria). The primary endpoint will be assessed only in patients receiving exclusively the Endeavor ZES during index (and staged) procedure.
次要结局
- Rates of Stent thrombosis(until 24 and 36 months)
- Target vessel revascularization (TVR) and target lesion revascularization (TLR)(6 and 12 months)
- MACE (major adverse cardiac events) at in-hospital, 30 days, 6, 12, 18, 24 and 36 months; DAPT compliance (according to treatment allocation in the trial)(until 36 months)
- Major bleeding according to the modified REPLACE-2 and GUSTO criteria events at 1, 3, 6 and 12 months follow-up(until 12 months)