Prospective, Randomized Trial of Rapamycin- and Zotarolimus-eluting Stents for the Reduction of Coronary Restenosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3,002
- 试验地点
- 4
- 主要终点
- A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
研究概览
简要总结
The purpose of this trial is to evaluate the efficacy of Rapamycin- and Zotarolimus-Eluting stents for the reduction of Coronary Restenosis
详细描述
This prospective, randomized trial will compare the efficacy and safety of a Rapamycin plus Probucol-eluting stent with a polymer based Zotarolimus-eluting stent. Patients with symptomatic coronary artery disease without cardiogenic shock who will undergo coronary angiography and willing to participate in the trial will receive a loading dose of 600mg clopidogrel at least 2 hours before the procedure. They will be randomized to receive one of the above mentioned stents.
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
- 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 older than age 18 with ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% de novo stenosis located in native coronary vessels
- •Written, informed consent by the patient or her/his legally-authorized representative for participation in the study
- •In women with childbearing potential a negative pregnancy test is mandatory.
排除标准
- •Target lesion located in the left main trunk.
- •Target lesion located in the bypass graft.
- •In-stent restenosis.
- •Cardiogenic shock.
- •Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
- •Known allergy to the study medications: Clopidogrel, Rapamycin, Probucol, Zotarolimus, stainless steel or cobalt chrome.
- •Inability to take clopidogrel for at least 6 months.
- •Pregnancy (present, suspected or planned) or positive pregnancy test.
- •Previous enrollment in this trial.
- •Patient's inability to fully cooperate with the study protocol.
结局指标
主要结局
A composite endpoint of cardiac death, myocardial infarction related to the target vessel or target lesion revascularisation
时间窗: at one year
次要结局
- Late luminal loss(at 6-8 months follow-up angiography)
- stent thrombosis(at one year)