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

Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium

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.

Study Overview

• Status: Recruiting
• Conditions: Early PCSK9 Inhibitor on Ventricular Remodling
• Intervention / Treatment: Drug: standard medications; Drug: PCSK9 inhibitor （Alirocumab）plus standard medications

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Recruiting
    • Shanghai Tenth People's Hospital
  • Shanghai
    • Shanghai, Shanghai, China
      • Recruiting
      • Tongren Hospital, Shanghai

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai Tong Ren Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 12, 2021
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): December 1, 2023

Study Registration Dates

• First Submitted: January 23, 2021
• First Submitted That Met QC Criteria: January 28, 2021
• First Posted (Actual): January 29, 2021

Study Record Updates

• Last Update Posted (Estimate): March 7, 2023
• Last Update Submitted That Met QC Criteria: March 5, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 2021HL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No