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

RECRUITING

NCT05292404

PHASE4

Sponsor: Shanghai Tong Ren Hospital

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.

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

160

Start Date

2022-10-01

Completion Date

2026-12

Last Updated

2026-01-27

Healthy Volunteers

No

Conditions

Acute Myocardial Infarction

Interventions

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

conventional treatment were given according to international uniformguidelines