Atorvastatin Pre-Treatment Influences the Risk of Percutaneous Coronary Intervention Study 2
试验速览
- 阶段
- 3 期
- 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) on chronic statin therapy. Patients are randomized into two groups: atorvastatin pre-treatment group (80mg atorvastatin seven days before PCI) and control group (PCI without atorvastatin pretreatment, chronic statin treatment). Endpoint is myocardial infarction measured by troponin I and creatine kinase myocardial band.
详细描述
This randomized study investigates potential protective effect of high dose atorvastatin pre-treatment in patient with stable coronary artery disease undergoing percutaneous coronary intervention (PCI) and chronic statin therapy.
Two arms:
- atorvastatin pre-treatment group (80mg atorvastatin for seven days)
- control group (without atorvastatin pre-treatment, chronic statin treatment)
Primary endpoint:
Periprocedural myocardial infarction measured by troponin I level (time frame 24 hours)
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for percutaneous coronary intervention
- •Informed consent
- •Chronic statin therapy
排除标准
- •Acute coronary syndrome in last 14 days
- •Renal insufficiency (creatinine more 150 umol/l)
- •Diseases severely limiting prognosis
- •Previous participation in this study
- •Chronic occlusion of the coronary artery, bypass intervention, left main intervention
- •Chronic statin treatment with atorvastatin 80mg daily and rosuvastatin
研究组 & 干预措施
Atorvastatin
Atorvastatin 80mg seven days pre-treatment before PCI
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 after PCI
次要结局
- periprocedural myocardial infarction measured by creatinine kinase myocardial band(24 hours after PCI)