NCT07290699

Intensive Cholesterol-Lowering Within 24 Hours of PCI Perioperative Period

INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 2,442 (estimated)
• Sponsor: Second Affiliated Hospital of Nanchang University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study is a multicenter, prospective, randomized controlled trial, with the Second Affiliated Hospital of Nanchang University as the leading center and 80 sub-centers established. The enrollment period is from September 1, 2025, to August 30, 2027, with a follow-up of 1 year. A total of 2,442 patients who meet the inclusion criteria will be randomly assigned to: Group 1 (G1, experimental group): intensive lipid-lowering therapy within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors) for 6 months; Group 2 (G2, control group): standard lipid-lowing treatment (20 mg atorvastatin/10 mg rosuvastatin ± cholesterol absorption inhibitors). After 6 months, both groups will continue treatment according to guideline-recommended standard therapy. Randomization method: All eligible patients entering the respective groups will be randomly obtained a random number. The maximum follow-up period is 1 year. Safety evaluation includes monitoring all adverse events (AEs), serious adverse events (SAEs), as well as regular monitoring of vital signs and clinical laboratory tests. Each center will screen hospitalized AMI patients according to inclusion and exclusion criteria. Baseline data will be entered into the CRF form for the first time, including basic patient information, admission details, laboratory and instrument examinations, surgical procedure details, postoperative medications, and occurrence of adverse events during hospitalization. After discharge, follow-up visits will be conducted at 1 month, 3 months, 6 months, 9 months, and 1 year, inquiring about current health status and medication usage, and recording the occurrence of endpoint events and lipid levels in the follow-up section of the CRF.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-01-01
• Primary completion: 2027-08-30
• Completion: 2028-08-30
• First posted: 2025-12-18
• Last updated: 2025-12-18