Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

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.

NCT Number	NCT07290699
Lead Sponsor	Second Affiliated Hospital of Nanchang University Collaborators: First Affiliated Hospital of Gannan Medical University, Jiujiang No.1 People's Hospital, First People's Hospital of FuZhou, Yueyang Central Hospital, The First People's Hospital of Changde City, ZhuZhou Central Hospital, Xiangtan Central Hospital, Loudi Central Hospital
Conditions	STEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI)
Enrollment	2,442 participants
Start Date	2026-01-01
Primary Completion	2027-08-30 (estimated)
Study Completion	2028-08-30 (estimated)
Updated on ClinicalTrials.gov	2025-12-18