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.
Age ≥18 years;
Meet the definition of acute myocardial infarction according to the "2019 Guidelines for the Diagnosis and Treatment of Acute ST-Segment Elevation Myocardial Infarction", including STEMI and NSTEMI with onset <24 hours;
Able to understand and voluntarily sign the informed consent form.
Severe mental disorders that prevent the expression of consent;
Severe heart failure (Killip class III or IV) or cardiogenic shock;
According to the investigator's judgment, the presence of significant other abnormal signs, laboratory findings, or clinical conditions (such as tumors, shock, liver or kidney failure, etc.) that make participation unsuitable;
Investigator's judgment that the subject cannot complete long-term follow-up;
Parallel
Recaticimab
DrugRecaticimab 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.
MACE
The primary endpoint was 1-year MACE (major adverse cardiovascular and cerebrovascular events, including cardiac death, non fatal myocardial infarction, non fatal stroke, or hospitalization due to unplanned unstable angina and coronary revascularization).
LDL-C reduction absolute value
LDL-C reduction absolute value means, it refers to the LDL-C value measured in the 12th month minus the LDL-C value measured at baseline.
LDL-C targets achieved rate
LDL-C targets achieved rate, it refers to whether the LDL-C at the 12th month has reached the target value recommended by the guidelines for the patient.
Changes in Lp (a) levels
Changes in Lp (a) levels, it refers to the changes in baseline Lp (a) levels and Lp (a) levels at the 12th month
Changes in the size of carotid plaques
Record changes in carotid plaque size at baseline and 12-month follow-up
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Second Affiliated Hospital of Nanchang University
Lead sponsor
First Affiliated Hospital of Gannan Medical University
Collaborator
Jiujiang No.1 People's Hospital
Collaborator
First People's Hospital of FuZhou
Collaborator
Yueyang Central Hospital
Collaborator
The First People's Hospital of Changde City
Collaborator
ZhuZhou Central Hospital
Collaborator
Xiangtan Central Hospital
Collaborator
Loudi Central Hospital
Collaborator
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