Effects of Early Statin Treatment on Symptomatic Heart Failure and Ischemic Events After Acute Myocardial Infarction. The MUSASHI-AMI: A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 460
- 试验地点
- 1
- 主要终点
- A combination of: cardiovascular death
研究概览
简要总结
Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. The purpose of this study is to determine whether early (within 96 hours after onset) use of any available statins are effective to prevent cardiovascular events including heart failure after acute myocardial infarction in Japanese patients.
详细描述
At least, in Japanese, it was controversial if lipid-lowering therapy to the patients whose total cholesterol levels <240 mg/dL was needed. Furthermore, in general, a role for early statin therapy in patients with ST-elevated AMI reperfused by primary PCI has not been clearly established. Statins have been shown to prevent coronary artery disease and to preserve left ventricular function in dilated cardiomyopathy. The investigators hypothesized that the early use of statins would reduce cardiovascular events including heart failure in acute myocardial infarction patients. A prospective, randomized, open-label, multicenter trial is conducted in AMI patients with normal total cholesterol levels (180-240 mg/dL). Patients are randomly assigned to receive any available statin within 96 hours of AMI onset or no statin and were followed for up to 24 months. The primary endpoint is a composite of cardiovascular death, nonfatal AMI, recurrent symptomatic myocardial ischemia, congestive heart failure, and stroke.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of acute myocardial infarction
- •Serum total cholesterol levels on admission ranges ≥180 mg/dL and <240 mg/dL
排除标准
- •Age < 18 years
- •Time from symptom onset to admission > 96 hours
- •Use of lipid-lowering agents within the previous 3 months
- •Known familial dyslipidemia
- •Severe renal failure
- •Known hepatic disease
- •Signs and symptoms of severe heart failure (Killip class III or IV)
- •A scheduled PCI or coronary artery bypass grafting (CABG)
- •A history of previous PCI (within 6 months) or CABG (within 3 months)
- •The presence of malignant disease
- •The presence of allergy to statins.
研究组 & 干预措施
Statins
干预措施: lipid-lowering treatment (Drug)
结局指标
主要结局
A combination of: cardiovascular death
nonfatal acute myocardial infarction
recurrent symptomatic myocardial ischemia with objective evidence and requiring emergency rehospitalization
congestive heart failure requiring emergent rehospitalization
and nonfatal stroke
次要结局
- Reintervention procedures: coronary artery bypass grafting (CABG)
- percutaneous coronary intervention (PCI) for a new lesion
- and repeat PCI procedures for restenosis of the infarct-related or non-infarct-related lesions (repeat PCI occurring in the first 6 months of follow-up for an index lesion was excluded)
研究者
Hisao Ogawa
Pofessor
Kumamoto University