NSTEMI - Non-ST Segment Elevation Myocardial Infarction (MI), STEMI - ST Elevation Myocardial Infarction
Conditions
Keywords
Acute myocardial infarction, Recaticimab, PCSK9 inhibitor
Brief 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.
Interventions
DRUGRecaticimab
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
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
Second Affiliated Hospital of Nanchang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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; * Intolerance to statins or cholesterol absorption inhibitors; * Intolerance to injections; * Subjects who received PCSK9 inhibitor treatment or participated in other PCSK9 inhibitor studies within 4 months before randomization; * Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACE | From enrollment to the end of treatment at 12 months | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LDL-C targets achieved rate | From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible | 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 | From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible | 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 | From baseline to the mid at 6 months and end of treatment at the 12 months | Record changes in carotid plaque size at baseline and 12-month follow-up |
| Observation indicators of safety | From enrollment to the end of treatment at 1, 3, 6, 9 ,12 months. | Adverse events (AEs) are defined as any adverse medical events that occur during the period from the signing of informed consent by clinical trial subjects until the completion of the study. |
| LDL-C reduction absolute value | From enrollment to the end of treatment at 12 months, and record the values for every 1, 3, 6, 9, and 12 months if possible. | 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. |
| Cardiac death | From enrollment to the end of treatment at 6 months and 1 year | Record cardiac death at 6 months and 1 year |
| Non fatal myocardial infarction | From enrollment to the end of treatment at 6 months and 1 year. | Recard non fatal myocardial infarction at 6 months and 1 year. |
| Non fatal stroke | From enrollment to the end of treatment at 6 months and 1 year | Record non fatal stroke at 6 months and 1 year |
| Hospitalization due to unplanned unstable angina and coronary revascularization | From enrollment to the end of treatment at 6 months and 1 year. | Record hospitalization due to unplanned unstable angina and coronary revascularization at 6 months and 1 year. |
| The occurrence rate of MACE events in 6 months | From enrollment to the end of treatment at 6 months. | 6-month incidence of MACE events (referring to cardiac death, non fatal myocardial infarction, hospitalization due to unstable angina, and coronary revascularization); |
Contacts
Primary ContactLong Jiang, Ph.D.
Outcome results
None listed