Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- eject fraction measured by MRI
研究概览
简要总结
This is a prospect, multi-center, random study to investigate whether early offering PCSK9 inhibitor to acute myocardium infarction(AMI) can alleviate ventricular remodeling after primary percutaneous intervention(PPCI). Totally,twenty acute myocardium infarction subjects will be enrolled in this study after consent information. After randomization, the control group will receive standard therapy for AMI including PPCI. The experiment group will receive first PCSK9 inhibitor before PPCI, then twice a month until 3 months later. Six month after AMI, Myocardial salvage index will be used to evaluate ventricular remodeling. TnI peaking time and LDL control rates also will be recorded and compared.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age and less than 80 years old
- •Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
- •Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure
排除标准
- •Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
- •Known hypersensitivity or contraindication to study medications
- •Plan to receive revascularization in next six month.
- •Have received revascularization before.
- •Subjects with life expectation less than one year.
- •Subjects with active malignant tumor
- •subjects with severe liver or renal dysfunction（ALT >5 倍 ULA，eGFR<15ml/min/1.73mm2）
- •Other conditions which the investigators think not applicable to the study.
研究组 & 干预措施
standard group
干预措施: standard medications (Drug)
experiment group
干预措施: PCSK9 inhibitor （Alirocumab）plus standard medications (Drug)
结局指标
主要结局
eject fraction measured by MRI
时间窗: six month after PPCI
myocardial salvage index measured by MRI
时间窗: six months after PPCI
次要结局
- the change of serum level of TnI/T(0,6 ,12,18 , 24 ,30,and 36 hours after PPCI)
- LDL -C control rate(the first month after PPCI)
- the serum lever of hsCRP(one week after PPCI)
研究者
Hou Lei
Principal Investigator
Shanghai Tong Ren Hospital