Intensive Lipid Lowering Treatment in Patients With Non-ST-elevation ACS Undergoing Percutaneous Coronary Intervention
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.
研究概览
简要总结
PCI has been one of the most common choice of treatments for patients with coronary artery disease, and studies indicated that intensive statin treatment before PCI could reduce adverse events as comparing to the placebo. In China, statin with regular dose is currently applied to the patients admitted for Non-ST-elevation acute coronary syndrome (ACS). Here we hypothesize that intensive statin treatment with arovastatin before PCI could further reduce clinical adverse events.
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 (Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •finish informed consent
- •age≥18y and under 75y
- •diagnosed as non-ST elevation acute coronary syndrome, including unstable angina and non-ST elevation myocardial infarction
- •willing to receive the coronary angiography and potential PCI therapy
排除标准
- •patient was treated by statins before randomization
- •stable angina or ST elevation myocardial infarction
- •without informed consent
- •abnormal liver function before randomization, (AST，ALT≥3ULN)
- •active hepatitis or muscular disease
- •impaired renal function with serum creatinine level > 3mg/dl
- •impaired left ventricular systolic function with LVEF< 30%
- •participating in other studies
- •non-PCI treated patients after coronary angiography will be washed out
研究组 & 干预措施
conventional group
patients will be treated by atorvastation 20mg/d after randomization, and continued for one year.
干预措施: Atorvastatin (Drug)
intensive group
patient will be loaded with 80mg atorvastatin, continued by atorvastatin 40mg/d for 30d, then receive atorvastatin 20mg/d for the following 11 months.
干预措施: Atorvastatin (Drug)
结局指标
主要结局
The primary end point was the composite of major adverse cardiac events (MACE), including cardiac death, non-fatal reinfarction, and target vessel revascularization (TVR) at one-year clinical follow-up after randomization.
时间窗: one year
次要结局
- MACE at 30d after randomization 3. changes of left ventricular function at 30d after randomization(30 days)
- changes of left ventricular function at 30d after randomization(30 days)
- rate of peri-procedural myocardial infarction(30days)