Impact of Early PCSK9 Inhibitor on Heart After Acute Myocardium Infarction

NCT04731155 | Recruiting Phase 4

• 1 other identifier: 2021HL
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

Early PCSK9 Inhibitor on Ventricular Remodling

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (4)

• 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

Study Arms (2)

standard group

ACTIVE COMPARATOR

Drug: standard medications

experiment group

EXPERIMENTAL

Drug: PCSK9 inhibitor （Alirocumab）plus standard medications

Interventions

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

experiment group

standard medications DRUG

standard medications was giving to subjects according guidelines

standard group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Tong Ren Hospital: lead

Study Sites (2)

Tongren Hospital, Shanghai

Shanghai, Shanghai Municipality, China

RECRUITING

Shanghai tenth people's hospital

Shanghai, China

RECRUITING

Central Study Contacts

Lei Hou, Doctor

CONTACT

13564868096; Dr_houlei@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 23, 2021
• First Posted: January 29, 2021
• Study Start: April 12, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: May 21, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (2)