Recruiting

NCT Number: NCT04731155

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

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.

Recruiting

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Key information

Conditions

Early PCSK9 Inhibitor on Ventricular Remodling

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Tongren Hospital, Shanghai, Shanghai, Shanghai Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCSK9 inhibitor （Alirocumab）plus standard medications

Drug

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

standard medications

Drug

standard medications was giving to subjects according guidelines

Primary outcomes

myocardial salvage index measured by MRI

Time frame: one week after PPCI
myocardial salvage index measured by MRI

Time frame: six months after PPCI
eject fraction measured by MRI

Time frame: one week after PPCI
eject fraction measured by MRI

Time frame: six month after PPCI

Secondary outcomes

the change of serum level of TnI/T

Time frame: 0,6 ,12,18 , 24 ,30,and 36 hours after PPCI
LDL -C control rate

Time frame: the first month after PPCI
the serum lever of hsCRP

Time frame: Baseline (before PPCI)
the serum lever of hsCRP

Time frame: one week after PPCI

Study contacts

Contact information is provided by the study sponsor or research team.

Lei Hou, Doctor

CONTACT

[email protected]

13564868096

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Registry information

Official study title

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

Acronym: PERFECT-AMI

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jan 29, 2021
Registry last updated: May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.