A Randomized, Open Label, Comparative Study to Evaluate Effect of Pitavastatin for Reduction of Myocardial Damage in Patient Are Scheduled Elective PCI for Stable Angina Pectoris
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 试验地点
- 1
- 主要终点
- Proportion of patients whose CK-MB > 2 times above UNL
研究概览
简要总结
Patients who is scheduled elective PCI are randomized to pitavastatin 4mg daily or without pitavastatin for 5 -7days before the procedure. Creatine kinase-MB, troponin I, and myoglobin levels are measured at baseline and at 8 and 24 hours after the procedure(1st evaluation). After PCI, pitavastatin will be administered for additional 4 weeks(2nd evaluation).
详细描述
Procedural ischemic myocardial injury remains the most frequent complication after coronary angioplasty. Recently it was reported that pretreatment with atorvastatin reduce the myocardial damage compared to placebo. Thus, we will evaluate the difference of pretreatment of pitavastatin compared to standard therapy on the reduction of myocardial damage in patient who is scheduled elective PCI for stable angina pectoris.
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
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with LDL ≥ 100mg/dL
- •Patients who are scheduled an elective PCI for stable angina
排除标准
- •Acute myocardial infarction (<3 months)
- •Unstable angina
- •Previous treatment with statins (<6 months)
- •Increase in CK-MB above upper normal limit
- •Increase in liver enzymes (AST/ALT) above 2 times of upper normal limit
- •Increase in serum creatinine above 2 times of upper normal limit
- •Left ventricular ejection fraction <30%
- •Previous treatment with glycoprotein Ⅱb/Ⅲa receptor inhibitor (<4 weeks)
研究组 & 干预措施
Pitavastatin Group
干预措施: Pitavastatin (Drug)
Usual Care Group
干预措施: Pitavastatin (Drug)
结局指标
主要结局
Proportion of patients whose CK-MB > 2 times above UNL
时间窗: First evaulation time (before PCI)
次要结局
- Proportion of patients who show any increase of CK-MB, troponin I, and myoglobin above UNL(First evaluation time)
- Mean peak values of CK-MB, troponin I and myoglobin after intervention(After PCI (<24hrs))
- Change of hs-CRP, wall motion score(Second evaluation time)
- Occurence of all major adverse cardiac events(Second evaluation time)