Effect of Intensive Statin Treatment on 90-day Prognosis of STEMI Patients Undergoing Emergency Primary PCI Compared With Usual Care
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization
研究概览
简要总结
This is a retrospective, randomized, parallel, open-labeled, controlled study to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine treatment.
详细描述
ARMYDA-ACS, ARMYDA-RECAPTURE and NAPLES II demonstrated that in patients with ASP and NSTE ACS undergoing early PCI, loading dose of atorvastatin before early PCI led to a reduction of prei-PCI MI, recurrent CV events and mortality. While, theses studies included patients with non-ST-segment elevation ACS, requiring PCI; these results cannot be extrapolated directly to patients with ST-segment elevation MI, and these trials included patients sent to an early and selective PCI, but not those undergoing emergency revascularization;
This study is designed to find out whether STEMI patients undergoing emergency PCI can benefit from intensive atorvastatin treatment compared with routine 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
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20-75 years old
- •myocardiac ischemia symptom of index event appeared less than 12 hours before enrollment.
- •ECG showed elevated ST segment in 3 or more contiguous leads
- •diagnosed with acute STEMI
- •eligible for primary PCI, and primary PCI is scheduled within 2 hours after enrollment
排除标准
- •allergic or experienced serious adverse reaction to HMG-CoA reductase
- •pregnancy, lactation, or child bearing potential women without any effective contraception
- •accompanied with malignant disease
- •active hepatic disease or hepatic dysfunction
研究组 & 干预措施
usual care
干预措施: atorvastatin (Drug)
intensive statin treatment
干预措施: atorvastatin (Drug)
结局指标
主要结局
The combined endpoint of 90-day all cause morality, cardiac death, recurrent MI, recurrent symptomatic myocardiac ischemia, target vessel revascularization
时间窗: 2009 Dec- 2011 Mar
次要结局
未报告次要终点