Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction (PERFECT-AMI)

Shanghai Jiao Tong University

Status and phase: Enrolling; Phase 4

Conditions: Early PCSK9 Inhibitor on Ventricular Remodling

Treatments: Drug: standard medications; Drug: PCSK9 inhibitor （Alirocumab）plus standard medications

Study type: Interventional

Funder types: Other

Identifiers

NCT04731155

2021HL

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Subject must be at least 18 years of age and less than 80 years old
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for AMI and LAD should be the only culprit vessel.
3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion criteria

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Known hypersensitivity or contraindication to study medications
3. Plan to receive revascularization in next six month.
4. Have received revascularization before.
5. Subjects with life expectation less than one year.
6. Subjects with active malignant tumor
7. subjects with severe liver or renal dysfunction（ALT >5倍ULA，eGFR<15ml/min/1.73mm2）
8. Other conditions which the investigators think not applicable to the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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20 participants in 2 patient groups

standard group

Active Comparator group

Treatment:

Drug: standard medications

experiment group

Experimental group

Treatment:

Drug: PCSK9 inhibitor （Alirocumab）plus standard medications