INtensive Cholesterol-Lowering With recatIcimab combiNation in Emergency PCI for Acute Myocardial Infarction: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 2,442
- 主要终点
- MACE
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Intervention Group
Intensive lipid-lowering within 24 hours during the perioperative period of AMI (standard treatment + PCSK9 inhibitors)；Recaticimab 450 mg once every 12 weeks
干预措施: Recaticimab (Drug)
结局指标
主要结局
MACE
时间窗: 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).
次要结局
- Non fatal myocardial infarction(From enrollment to the end of treatment at 6 months and 1 year.)
- Non fatal stroke(From enrollment to the end of treatment at 6 months and 1 year)
- 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 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)
- 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 the size of carotid plaques(From baseline to the mid at 6 months and end of treatment at the 12 months)
- Observation indicators of safety(From enrollment to the end of treatment at 1, 3, 6, 9 ,12 months.)
- The occurrence rate of MACE events in 6 months(From enrollment to the end of treatment at 6 months.)
- Cardiac death(From enrollment to the end of treatment 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.)