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

Phase

Condition

Blood Clots

Occlusions

Heart Disease

Treatment

alirocumab

conventional treatment

Clinical Study ID

NCT05292404

ShanghaiTRH-HL2022

Ages 18-75
All Genders

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 Criteria

Inclusion

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 areplanning to undergo PPCI .
Signed informed consent.

Exclusion

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 thisstudy.

Study Design

alirocumab

October 01, 2022

December 31, 2026

Connect with a study center

Shanghai chest hospital
Shanghai, Shanghai 200050
China
Active - Recruiting
Shanghai tongren hospital
Shanghai, Shanghai 200050
China
Active - Recruiting
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai
China
Site Not Available
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai, Shanghai 200050
China
Active - Recruiting
tenth people's hospital, tongji university, Shanghai
Shanghai, Shanghai 200050
China
Active - Recruiting
Shanghai chest hospital
Shanghai 1796236, Shanghai Municipality 1796231 200050
China
Active - Recruiting
Shanghai tongren hospital
Shanghai 1796236, Shanghai Municipality 1796231 200050
China
Active - Recruiting
Songjiang hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai 1796236, Shanghai Municipality 1796231
China
Active - Recruiting
nineth people's hospital, School of Medicine, shanghai jiaotong university
Shanghai 1796236, Shanghai Municipality 1796231 200050
China
Active - Recruiting
tenth people's hospital, tongji university, Shanghai
Shanghai 1796236, Shanghai Municipality 1796231 200050
China
Active - Recruiting

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