Safety and Efficacy of Peri-procedural Use of Tirofiban in Elective Percutaneous Coronary Intervention for Long Coronary Lesions With Overlapping Drug-Eluting Stent
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 748
- 试验地点
- 1
- 主要终点
- periprocedural infarction
研究概览
简要总结
Periprocedural myonecrosis or infarction are associated with short, intermediate, and long term adverse outcomes. Previous study indicated 12.6% of patients suffered a peri-procedural CK-MB rise by overlapping use of drug-eluting stents for long coronary lesions. Here the investigators hypothesize that peri-procedural use of tirofiban could reduce the occurrence of periprocedural infarciton in elective patients with long coronary lesions treated by overlapping use of drug-eluting stents.
详细描述
According to the results of 12.6% occurrence of peri-procedural myocardial infarction after long stent implantation by previous report[International Journal of Cardiology 2009;134: 231-237], the investigator hypothesize the 50% reduction of peri-procedural MI by using tirofiban. Three hundred and sixty-nine patients in each group are needed to reach 80% of power with α 0.05.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18y~80y, with symptomatic coronary disease
- •At least one lesion length more than 40mm to be treated by overlapping drug-eluting stents in major epicardial coronary vessel
排除标准
- •Aspirin or clopidogrel intolerance
- •Lesions length less than 40mm, or overlapping stent length less than 40mm
- •Bifurcation lesions need to be treated by two stents
- •Patients with acute coronary syndrome and elevated baseline cardiac enzyme (CK-MB)
- •Left ventricular ejection fraction less than 0.35
- •Baseline estimated GFR less than 30
- •Estimated life time less than one year
- •Refuse to sign the informed consent
研究组 & 干预措施
Control group
normal saline was applied to those randomized to control group, with same use as tirofiban
干预措施: normal saline solution (Drug)
Tirofiban group
after angioram, and before guiding catheter engagement: 10μg/kg bolus followed by 0.15μg/kg/min maintenance infusion
干预措施: tirofiban (Drug)
结局指标
主要结局
periprocedural infarction
时间窗: 12h after procedure
definition of periprocedural MI is a CK elevation \>3 times the upper limit of normal.
次要结局
- major adverse cardiac event(one year after procedure)
- major bleeding(during hospitalization (up to 2 weeks))
研究者
Zhang Qi, MD
Vice Director of Cath. Lab
Shanghai Jiao Tong University School of Medicine