Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

Phase 4

Recruiting

• Conditions: Early PCSK9 Inhibitor on Ventricular Remodling
• Interventions: Drug: standard medications; Drug: PCSK9 inhibitor （Alirocumab）plus standard medications

• Registration Number: NCT04731155
• Lead Sponsor: Shanghai Tong Ren Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-23
• Study First Submitted QC: 2021-01-28
• Study First Posted: 2021-01-29
• Study Start: 2021-04-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2025-10
• Study Completion: 2025-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
standard group	standard medications	-
experiment group	PCSK9 inhibitor （Alirocumab）plus standard medications	-

Primary Outcome Measures

Name	Time	Method
eject fraction measured by MRI	six month after PPCI
myocardial salvage index measured by MRI	six months after PPCI

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (2)

Tongren Hospital, Shanghai; 🇨🇳 Shanghai, Shanghai, China

Shanghai tenth people's hospital; 🇨🇳 Shanghai, China