Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction

January 23, 2026 updated by: Hou Lei, Shanghai Tong Ren Hospital

Impact of Early PCSK9 Inhibitor Treatment on Heart After Acute Myocardium Infarction： a Muti-center, Open-label, Randomized Controlled Trial

This is a multi-center, prospective, randomized, controlled study. The patients with STEMI who were to undergo PPCI were divided into PCSK9 inhibitor group (n=80) and conventional treatment group (n=80) using the interactive web response system (IWRS), at a 1:1 ratio. In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months; the control group received conventional treatment. Cardiac Magnetic Resonance Imaging (MRI) were used to measure myocardial salvage index at 1 week after operation as primary endpoints. Eject fraction at 6 months after operation will also be measured by MRI as secondary endpoints. Serum TnI/T，CKMB levels were detected q8h for three times and and LDL-C levels were detected at 1 month, 3 months and 6 months after operation. Blood inflammation indicators were detected before and 1 week after the operation, and 6 months after the operation.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

160

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, China, 200050
        • Recruiting
        • nineth people's hospital, School of Medicine, shanghai jiaotong university
        • Contact:
          • Junfeng Zhang, doctor
      • Shanghai, Shanghai Municipality, China, 200050
        • Recruiting
        • Shanghai Chest Hospital
        • Contact:
          • zhenchi sang, doctor
      • Shanghai, Shanghai Municipality, China, 200050
        • Recruiting
        • Shanghai Tongren Hospital
        • Contact:
        • Principal Investigator:
          • Lei Hou, doctor
      • Shanghai, Shanghai Municipality, China, 200050
        • Recruiting
        • tenth people's hospital, tongji university, Shanghai
        • Contact:
          • Yi Zhang, doctor
      • Shanghai, Shanghai Municipality, China
        • Recruiting
        • Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
        • Contact:
          • Tongqing Yao, doc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. The age is greater than 18 years old and less than or equal to 80 years old.
  2. Patients who are clinically diagnosed with STEMI onset within 24 hours and who are planning to undergo PPCI .
  3. Signed informed consent.

Exclusion Criteria:

  1. Patients who are allergic to PCSK9 inhibitors.
  2. Multivessel disease planned for selective intervention within half a year.
  3. Patients who have previously undergone revascularization.
  4. Pregnant women or women who plan to become pregnant in the next 2 years.
  5. Patients whose life expectancy is less than 1 year.
  6. Severe liver or kidney dysfunction (ALT>5 times ULA, eGFR<15ml/min/1.73m2)
  7. Known active malignant tumor diseases.
  8. Patients considered by the investigator to be unsuitable to participate in this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Early PCSK9 inhibitor treatment group
Drug: alirocumab
In the PCSK9 inhibitor group, a dose of PCSK9 inhibitor (alirocumab,75mg) was injected subcutaneously immediately after PPCI and was administered every two weeks thereafter for 3 months
Other: conventional treatment group
Other: conventional treatment
conventional treatment were given according to international uniformguidelines

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
myocardial salvage index
Time Frame: 1 week after operation
measured by Magnetic Resonance Imaging (MRI)
1 week after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Eject fraction
Time Frame: at 6 months after operation
measured by MRI
at 6 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Tong Ren Hospital

Collaborators

China Cardiovascular Association

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 13, 2022

First Submitted That Met QC Criteria

March 21, 2022

First Posted (Actual)

March 23, 2022

Study Record Updates

Last Update Posted (Actual)

January 27, 2026

Last Update Submitted That Met QC Criteria

January 23, 2026

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ShanghaiTRH-HL2022

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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