Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

• Status: NOT_YET_RECRUITING
• Trial end date: 2028-08-30

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.

• Phase: PHASE4

Details

• Lead Sponsor: Second Affiliated Hospital of Nanchang University
• Collaborators: First Affiliated Hospital of Gannan Medical University; First People's Hospital of FuZhou; Jiujiang No.1 People's Hospital; Loudi Central Hospital; The First People's Hospital of Changde City; Xiangtan Central Hospital; Yueyang Central Hospital; ZhuZhou Central Hospital