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Clinical Trials in China / NCT05292404
Recruiting Phase 4

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

NCT05292404 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Tong Ren Hospital
Phase
Phase 4
Started
2022-10-01
Last updated
2026-01-27

Condition(s) studied

Acute Myocardial Infarction

Investigational drug(s) / intervention(s)

alirocumabconventional treatment

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

conventional treatment: conventional treatment were given according to international uniformguidelines

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (5)

FacilityCityRegionStatus
nineth people's hospital, School of Medicine, shanghai jiaotong university Shanghai Shanghai Municipality Recruiting
Shanghai chest hospital Shanghai Shanghai Municipality Recruiting
Shanghai tongren hospital Shanghai Shanghai Municipality Recruiting
tenth people's hospital, tongji university, Shanghai Shanghai Shanghai Municipality Recruiting
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine Shanghai Shanghai Municipality Recruiting

On this site

📄 Praluent (alirocumab) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05292404 on ClinicalTrials.gov ↗ ← All trials in China