NCT01265706已完成不适用
1-year, Prospective, Randomized, Open-label, Parallel Group Observational Study to Evaluate the Safety and Efficacy of 4mg/Day of Pitavastatin Versus 2mg/Day of Pitavastatin in Acute Myocardial Infarction(AMI)
JW Pharmaceutical1 个研究点 分布在 1 个国家目标入组 1,000 人开始时间: 2010年7月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Incidence of TLR-MACE for 1 year after enrollment
研究概览
简要总结
This study is performed to observe the incidence of major cardiovascular events in Korean patients with AMI after giving pitavastatin 2mg and 4mg longer than 1 year.
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
- •Patients with STEMI, NSTEMI
- •Patients satisfying at least one of the followings
- •Patients with LDL-C ≥ 130 mg/dL
- •Patients with LDL-C ≥ 100 mg/dL who are regarded as required cholesterol lowering therapy by the investigator
- •Patients taking statin are required continuous cholesterol lowering therapy
- •Patients satisfying at least two of the followings
- •The change of Ischemic ECG
- •CK, CK-MB, Troponin-I increased more than two times
- •The symptom of ACS
排除标准
- •Patients with in-stent restenosis after PCI or coronary artery bypass
- •Patients with cardiogenic shock
- •Patients with severe heart failure (Left ventricular ejection fraction is less than 30%)
- •Patients who are taking cyclosporine
- •Patients who experienced hypersensitivity to pitavastatin
- •Patients under dialysis treatment
- •Patients who are participating other clinical trials
- •Patients who can not stop taking concomitant drugs
- •Pregnant or lactating women or suspected pregnancy
- •Patients who are regarded as ineligible for this study by the investigator
结局指标
主要结局
Incidence of TLR-MACE for 1 year after enrollment
时间窗: 1 year after enrollment
次要结局
- Incidence of TVR-MACE for 1 year after enrollment(1 year after enrollment)
研究者
研究点 (1)
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