The Clinical Effect of Intensive Statin Therapy in STEMI(ST-elevated Myocardial Infarction) Patients Before Emergency PCI(Percutaneous Coronary Intervention)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- MACEs (Major adverse cardiac events)
研究概览
简要总结
The purpose of this study is to evaluate the clinical effect of intensive statin therapy before emergency PCI in patients with STEMI.
详细描述
150 STEMI patients planned for emergency PCI were randomized to three groups, Group 1:received atorvastatin 80-mg loading dose before PCI then followed by 40-mg daily for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 2:received atorvastatin 40-mg qd after PCI for one month and a maintenance dose of 20-mg qd thereafter(n=50); Group 3: received atorvastatin 20-mg qd after PCI (n=50).Before PCI,all subjects received oral administration of aspirin 300mg and clopidogrel 300mg.Levels of creatine kinase,CK-MB(creatine kinase-MB),were measured to estimate myocardial damage degree.HS-CRP(high sensitivity C -reactive protein),NO(NO synthase),SAA(Serum amyloid A) were measured at preoperation 1 hour,postoperative 24 and 72 hours,7days after PCI. To compare echocardiography changes among three groups.Patients enrolled in the study need to receive follow-up survey which was carried out by clinical doctors.Hence,MACEs were analyzed during 6-month follow-up.So, the aim of our study is to evaluate the clinical significance of loading dosage of atorvastatin therapy and analyze the mechanism underlying it.
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 (Participant)
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
- •1.Clinical diagnosis of STEMI less than 12 hours 2.Eligible for emergency PCI
排除标准
- •1.Contradiction to atorvastatin 2.Contradiction to aspirin, clopidogrel and contrast medium 3.Life expectancy less than 3 months 4.Tumor or inflammatory diseases
研究组 & 干预措施
group 1, Atorvastatin
STEMI patients will be randomly divided into three groups Group 1 which has been give 80mg atorvastatin before PCI will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
干预措施: Atorvastatin (Drug)
group 2 , Atorvastatin
Group 2 will be administered with atorvastatin 40mg per day for one month,then 20mg per day until the end of the trial
干预措施: Atorvastatin (Drug)
group 3 , Atorvastatin
Group 3 will be administered with atorvastatin 20mg per day until the end of the trial
干预措施: Atorvastatin (Drug)
结局指标
主要结局
MACEs (Major adverse cardiac events)
时间窗: follow-up for 6 months
MACEs were compared among three groups during follow-up in STEMI patients undergoing emergency PCI.
次要结局
- Echocardiographic changes(postoperative 6 month)
- HS-CRP,NO,SAA values(preoperation 1 hour,postoperative 24 and 72 hours,postoperative 7 days)
- CK,CK-MB(preoperation 1hour,postoperation 4/8/12/16/20/24hours)
- AST(glutamic-oxalacetic transaminease ),ALT(glutamic-pyruvic transaminase),LDL(low density lipoprotein cholesterin),TG(triglyceride)(preoperation 1 hour,postoperation 24 and 72hours,postoperation 7 days)