Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Study Overview
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Brief Summary
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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.

Official Title
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Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

Conditions
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Early PCSK9 Inhibitor on Ventricular Remodling

Intervention / Treatment
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* Drug: PCSK9 inhibitor （Alirocumab）plus standard medications
* Drug: standard medications


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard group<br> | Drug: standard medications<br>* standard medications was giving to subjects according guidelines<br>|
| Experimental: experiment group<br> | Drug: PCSK9 inhibitor （Alirocumab）plus standard medications<br>* PCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| myocardial salvage index measured by MRI |  | one week after PPCI | 
| myocardial salvage index measured by MRI |  | six months after PPCI | 
| eject fraction measured by MRI |  | one week after PPCI | 
| eject fraction measured by MRI |  | six month after PPCI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | Baseline (before PPCI) | 
| the serum lever of hsCRP |  | one week after PPCI |