NCT00781716Unknown不适用
Comparison of Safety and Efficacy of CYPHER® Sirolimus Stent and ENDEAVOR® Zotarolimus Stent in Patients With Acute ST Elevation Myocardial Infarction and Analysis of Current Status of Emergency PCI Green Channel for Patients With ST Elevation Myocardial Infarction in China
Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家目标入组 1,020 人开始时间: 2008年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,020
- 试验地点
- 1
- 主要终点
- Major Adverse Cardiac Events defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG)
研究概览
简要总结
This study is to compare the clinical effect of CYPHER® stent and ENDEAVOR® stent in patients with acute ST elevation myocardial infarction. It also aims to analyze the current status of emergency PCI green channel (time taken from door→ hospital→ PIC sign-off→ needle→ balloon) for patients with ST elevation myocardial infarction in China.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must be ≥18 years and ≤75 of age.
- •Prolonged, continuous (≥ 30 min) chest pain despite nitrate and: (1) ST-segment elevation ≥ at least 2 leads, with reciprocal ST-segment elevation ≥ 0.05mv and precordial leads ST-segment elevation ≥ 0.01mv, or (2) newly developed left bundle branch block
- •Symptoms ≥ 30 min and ≤12 hours
- •The patient has consented to participate and has authorized the collection and release of his medical information by signing the "Patient Informed Consent Form"
- •All lesions requiring interventions in one or more native coronary arteries are amendable for implantation of one or more Cypher® Sirolimus-Eluting Coronary Stent System or Endeavor® Zotarolimus-Eluting Coronary Stent
- •The patient or guardian is willing and able to cooperate with study procedures and required follow up visits.
排除标准
- •Pregnant and breast-feeding female and female of childbearing potential, who possibly plan to become pregnant any time after enrollment into this study.
- •Systemic (intravenous) Sirolimus use within 12 months.
- •Patients with hypersensitivity or allergies to one of the drugs or components indicated in the Instructions for Use of either stents.
- •History of bleeding diathesis or known coagulopathy (including heparin-induced thrombocytopenia), or will refuse blood transfusions.
- •Gastrointestinal or genitourinary bleeding within the prior 3 months, or major surgery within 2 months.
- •Current platelet count <100 x 10^9cells/L or Hgb <10 g/dL.
- •Fibrinolytic therapy for current MI treatment
- •Previous coronary intervention on target vessel or post-CABG vessel disease
- •Transplant patients
- •Patients with EF<25%
- •Patients with cardiogenic shock; with a life expectancy shorter than 12 months
- •Severe kidney dysfunction: Creatinine level ≥2.0mg/dL or dependence on dialysis.
- •Severe hepatic dysfunction (AST and ALT ≥ 3 times upper normal reference values).
- •The patient is currently, and during the CREST-MI Study, participating in another investigational device or drug study that clinically interferes with the CREST-MI study endpoints; or requires coronary angiography or other coronary artery imaging procedures. The patient may only be enrolled in the CREST-MI Study once.
- •Severe tortuous or calcified vessel; stent can not or has difficulty to go through; blood vessel diameter is smaller than the minimum stent diameter available; patients unsuitable for stent implantation.
结局指标
主要结局
Major Adverse Cardiac Events defined as death, MI (Q wave and non-Q wave), emergent cardiac bypass surgery, or target lesion revascularization (repeat PTCA or CABG)
时间窗: at 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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