Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

Summary

This project team is conducting a multicenter randomized controlled study, aiming to administer PCSK9 inhibitors subcutaneously as early as possible within 24 hours during the perioperative period of AMI (included \<24h STEMI and NSTEMI), and subsequently once every 12 weeks for a total of 6 months, followed by step-down therapy according to guideline-recommended lipid-lowering strategies based on LDL-C target levels. The study will evaluate changes in blood lipids and inflammatory markers during hospitalization and at follow-up visits at 1, 3, 6, 9, and 12 months, as well as the incidence of MACE events. Safety will also be assessed, including liver enzymes, kidney function, and other adverse reactions. Compared with conventional treatment, the study will test efficacy and ultimately clarify that early combined use of PCSK9 inhibitors during the perioperative period of AMI patients can safely and effectively reduce LDL-C, control systemic inflammatory responses, and improve the incidence of MACE events.

Conditions

• STEMI - ST Elevation Myocardial Infarction
• NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)

Interventions

DRUG

Recaticimab

Recaticimab 450 mg once every 12 weeks. Group 1 (G1, experimental group): Intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors), treatment for 6 months; Group 2 (G2, control group): standard treatment (antiplatelet drugs, 20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups continued with guideline-recommended conventional treatment.

Sponsors & Collaborators

• First Affiliated Hospital of Gannan Medical University

  collaborator OTHER

• Jiujiang No.1 People's Hospital

  collaborator OTHER

• First People's Hospital of FuZhou

  collaborator OTHER

• Yueyang Central Hospital

  collaborator OTHER

• The First People's Hospital of Changde City

  collaborator OTHER

• ZhuZhou Central Hospital

  collaborator OTHER

• Xiangtan Central Hospital

  collaborator OTHER

• Loudi Central Hospital

  collaborator OTHER

• Second Affiliated Hospital of Nanchang University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-01

Primary Completion

2027-08-30

Completion

2028-08-30