RecruitingPhase 4NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

Sponsor

Shanghai Tong Ren Hospital

Enrollment

20 participants

Start Date

Apr 12, 2021

Study Type

INTERVENTIONAL

Conditions

Early PCSK9 Inhibitor on Ventricular Remodling

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria3

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 Criteria8

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.

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Interventions

DRUGPCSK9 inhibitor （Alirocumab）plus standard medications

PCSK9 inhibitor（Alirocumab） was giving to subjects before PPCI and continued twice a month until 3 month after AMI

DRUGstandard medications

standard medications was giving to subjects according guidelines

Locations(2)

Tongren Hospital, Shanghai

Shanghai, Shanghai Municipality, China

Shanghai tenth people's hospital

Shanghai, China

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NCT04731155