Sequential Therapy of Atorvastatin Improving Tissue Reperfusion and Clinical Outcomes of ST-elevated Acute Myocardial Infarction Study（The STRAIT Study）
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,200
- 试验地点
- 1
- 主要终点
- Major Adverse Events (MACE) Occourance Rate
研究概览
简要总结
Statins have been approved to benefit patients underwent percutaneous coronary intervention (PCI). The current study is designed to evaluate the effectiveness and safety of Sequential Therapy of Atorvastatin in patients with ST-elevated myocardial infarction and receive PCI treatment.
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 (Outcomes Assessor)
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
- •Sighed informed consent
- •Diagnosised as acute myocardial infarction
- •Time frame less than 12 hours since the occurance of chest pain
- •Aggred to receive sirolimus-eluted coronary stents
- •Patients willing to accepte follow-up
排除标准
- •Allegy to statins or with a history against statin therapy
- •Allegy to any products that will be used during PPCI
- •Disagreed to receive PPCI and other related therapy
- •Existing sever liver dysfuntion that statins can not be used according to the guildlines
- •Sever kidney dysfunction (creatinine >3mg/dl or eGFR<30ml/min)
- •Sever left ventricular dysfunction (Killip grade 3)
- •Patients are currently taking medicine that may influence the use of statin
- •Patients with a history of alcohol abuse or durg abuse
- •Woman during pregnancy or lactation
- •Patients who has attended other clinical trials
- •Patients who has received PCI or CABG previously
- •Patients who can not agree to accept study protocol
- •Other conditions that may not sutible for the current study
研究组 & 干预措施
sequential therapy group
80mg atorvastatin before primary PCI (PPCI) followed by 40mg/d for 7 days after PPCI followed by 20mg/d for 1 year
干预措施: Sequential therapy of atorvastatin (Drug)
Usual Therapy of atorvastatin
20mg/d before and after PPCI for 1 year
干预措施: Sequential therapy of atorvastatin (Drug)
结局指标
主要结局
Major Adverse Events (MACE) Occourance Rate
时间窗: 30 days
1. Cardiac Death (CD) 2. Non-fatal re-inarction (CK-MB, cTNI or cTNT elevation again and over 3 times higher than up normal limit accompanied with syptoms or EKG indication) 3. revascularization driven by syptoms (CABG or re-PCI)
次要结局
- Secondary Endpoints(12 months)
研究者
Zhang Qi, MD
Visa Chief of Department of Cardiology
Shanghai Jiao Tong University School of Medicine