Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- periprocedural myocardial infarction measured by troponin I level
研究概览
简要总结
This study investigates potential protective effect of atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI). Patient are randomized to two groups: atorvastatin pre-treatment group (80mg atorvastatin two days before PCI) and control group (PCI without atorvastatin pretreatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
详细描述
Randomized studies have shown that pre-treatment with atorvastatin may reduced periprocedural myocardial in patient with stable angina during elective PCI. These data provide evidence-based support for using atorvastatin 7 days before PCI (dosage 40mg/d), alternatively three or more days (unknown dosage). We want to confirm this results for shorter pre-treatment period (two days) with dosage 80mg per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable angina in last month
- •indication for percutaneous coronary intervention
- •informed consent
排除标准
- •acute coronary syndrome in last 14 days
- •renal insufficiency (creatinine more 150 µmol/l)
- •diseases severely limiting prognosis
- •immunosuppressive treatment
- •statin one month before randomization
- •occlusion of the coronary artery
- •previous participation in this study
研究组 & 干预措施
atorvastatin
atorvastatin pre-treatment group (80mg atorvastatin two days before PCI)
干预措施: Atorvastatin (Drug)
control
PCI without atorvastatin pretreatment
干预措施: Atorvastatin (Drug)
结局指标
主要结局
periprocedural myocardial infarction measured by troponin I level
时间窗: 24 hours
次要结局
- periprocedural myocardial infarction measured by creatine kinase myocardial band(24 hours)