A Prospective Clinical Observation Study to Evaluate the Influence of Long Term Treatment of Pitavastatin on the Therapeutic Prognosis and Safety in Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,128
- 试验地点
- 10
- 主要终点
- Death/MACE for 1 year after the registration
研究概览
简要总结
Statins are usually used in AMI patients due to its strong anti-lipidemic effect, pleiotropic effect and tolerable safety profiles. Generally AMI patients are prescribed many drugs concomitantly; there are some risks due to the drug interaction. Especially, statins are reported to have many drug interactions, these might influence to therapeutic prognosis and safety in AMI patients.
This study is conducted to administer the non-CYP3A4 metabolized statin, pitavastatin to AMI patients over 1 year, and the results will be compared with the other results from the KAMIR study which is expected to the large scale of AMI patients using statins be enrolled. Finally, from that comparison, we will investigate the influence of the statins metabolism by CYP3A4 to the therapeutic prognosis like death, major adverse cardiac events(MACE), and major ADR of statins like CK increase, myalgia.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patients who have taken pitavastatin since AMI
排除标准
- 未提供
结局指标
主要结局
Death/MACE for 1 year after the registration
时间窗: 1 year
次要结局
- Achievement of LDL cholesterol target level according to the NCEP ATP III guideline(1 year)
- Abnormal change of lab value including CK etc(1 year)
- Adverse event including myalgia(1 year)