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

Phase 4

Recruiting

• Conditions: Acute Myocardial Infarction
• Interventions: Other: conventional treatment; Drug: alirocumab

• Registration Number: NCT05292404
• Lead Sponsor: Shanghai Tong Ren Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-13
• Study First Submitted QC: 2022-03-21
• Study First Posted: 2022-03-23
• Study Start: 2022-10-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-18
• Last Update Posted: 2024-12-20
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
conventional treatment group	conventional treatment	-
Early PCSK9 inhibitor treatment group	alirocumab	-

Primary Outcome Measures

Name	Time	Method
myocardial salvage index	1 week after operation	measured by Magnetic Resonance Imaging (MRI)

Secondary Outcome Measures

Name	Time	Method
Eject fraction	at 6 months after operation	measured by MRI

Trial Locations

Locations (5)

nineth people's hospital, School of Medicine, shanghai jiaotong university; 🇨🇳 Shanghai, Shanghai, China

Shanghai chest hospital; 🇨🇳 Shanghai, Shanghai, China

Shanghai tongren hospital; 🇨🇳 Shanghai, Shanghai, China

tenth people's hospital, tongji university, Shanghai; 🇨🇳 Shanghai, Shanghai, China

Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China