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NCT Number: NCT05292404

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

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.

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Key information

Conditions

Acute Myocardial Infarction

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Shanghai chest hospital, Shanghai, Shanghai Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Alirocumab

Drug

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

conventional treatment

Other

conventional treatment were given according to international uniformguidelines

Primary outcomes

  1. myocardial salvage index

    Time frame: 1 week after operation

    measured by Magnetic Resonance Imaging (MRI)

Secondary outcomes

  1. Eject fraction

    Time frame: at 6 months after operation

    measured by MRI

Study contacts

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

Lei Hou, doctor

CONTACT

[email protected]

86-13564868096

Sponsors and collaborators

Lead sponsor

Shanghai Tong Ren Hospital

Other

Collaborators

  • China Cardiovascular Association

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Mar 23, 2022
Registry last updated
Jan 27, 2026

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.

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