Impact of PCSK9 Monoclonal Antibody Very Early Administered in Hospital to Reduce Cardiovascular Events in Acute Myocardial Infarction (IMMEDIATE -MI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,518
- 试验地点
- 1
- 主要终点
- Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
研究概览
简要总结
Acute myocardial infarction (AMI) remains a major cause of morbidity and mortality, particularly in patients with multivessel coronary artery disease. Although primary percutaneous coronary intervention (PCI) has significantly improved short-term outcomes, these patients remain at high risk of recurrent cardiovascular events due to vulnerable non-culprit plaques. Coronary imaging techniques such as intravascular ultrasound (IVUS), optical coherence tomography (OCT), and angiography-derived indices (QFR, RWS) can identify high-risk lesions, but the optimal management strategy is still debated.
Early and intensive lipid-lowering therapy has been shown to stabilize atherosclerotic plaques. PCSK9 monoclonal antibodies, in combination with statins, provide rapid and profound LDL-cholesterol reduction and may enhance plaque stabilization beyond standard therapy. Small imaging studies suggest favorable effects of PCSK9 inhibitors on fibrous cap thickness and lipid burden, but their impact on clinical outcomes in AMI patients with multivessel disease remains uncertain.
This study aims to evaluate whether very early in-hospital administration of a PCSK9 inhibitor, in addition to standard care, can reduce major adverse cardiovascular events (MACE) over 12 months compared with standard lipid-lowering therapy alone. The trial will also explore imaging-based markers of plaque vulnerability and functional indices as secondary endpoints, in order to better understand the mechanisms linking lipid lowering, plaque stabilization, and clinical outcomes.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years.
- •Acute myocardial infarction (AMI) onset within 30 days (first hospitalization with a confirmed diagnosis of STEMI or NSTEMI).
- •Multivessel coronary artery disease; successful percutaneous coronary intervention (PCI) of the culprit lesion in the infarct-related artery (IRA), including stent implantation and/or balloon angioplasty and/or thrombus aspiration.
- •At least one angiographically assessed diameter stenosis ≥50% in a non-infarct-related artery (non-IRA) with a reference vessel diameter ≥2.5 mm.
- •Able to understand and willing to provide written informed consent, comply with prescribed medical therapy, and complete the required follow-up.
排除标准
- •Cardiogenic shock or severe heart failure (Killip class IV).
- •Serum creatinine >150 μmol/L or glomerular filtration rate (GFR) <45 mL/min/1.73 m² calculated by the Cockcroft-Gault equation.
- •Known or suspected infective endocarditis or active systemic infection.
- •Clinically significant coagulation abnormalities, or anticipated inability to tolerate long-term antiplatelet therapy.
- •Pregnant or breastfeeding women, women planning pregnancy within 1 year, or those unwilling to use effective contraception.
- •Expected survival <1 year.
- •Allergy to iodinated contrast media.
- •Prior coronary artery bypass grafting (CABG).
- •Participation in another clinical trial within 3 months before enrollment, or current participation in another drug/device clinical trial without having reached its primary endpoint.
- •Coronary angiography-based exclusion criteria:
- •10.1 Non-IRA lesion with visually estimated diameter stenosis >90% and TIMI flow ≤2; 10.2 Complex coronary artery disease requiring CABG; 10.3 Angiography unable to clearly identify the infarct-related artery or non-infarct-related arteries.
研究组 & 干预措施
Standard Lipid-Lowering Therapy
Participants will receive guideline-recommended lipid-lowering therapy starting with statins. Based on follow-up lipid levels, additional agents such as ezetimibe and PCSK9 inhibitors may be added sequentially, according to routine clinical practice.
干预措施: Standard Lipid-Lowering Therapy (Drug)
Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor)
Participants will receive early intensive lipid-lowering therapy with a PCSK9 monoclonal antibody initiated during index hospitalization, in addition to statins. Ezetimibe may be added as needed. The PCSK9 inhibitor will be given regardless of baseline lipid levels.
干预措施: Early Intensive Lipid-Lowering Therapy (PCSK9 Inhibitor) (Drug)
结局指标
主要结局
Incidence of Major Adverse Cardiovascular Events (MACE) at 12 Months
时间窗: 12 months after index percutaneous coronary intervention (±30 days)
MACE is defined as a composite endpoint including all-cause death, non-fatal myocardial infarction, stroke, unplanned ischemia-driven revascularization, and rehospitalization for unstable angina. The occurrence of the first event from this composite will be recorded for each participant.
次要结局
- Incidence of Key Secondary Cardiovascular Events(12 months after index PCI (±30 days))
- Incidence of All-Cause Death(12 months after index PCI (±30 days))
- Incidence of Non-fatal Myocardial Infarction(12 months after index PCI (±30 days))
- Incidence of Non-fatal Ischemic Stroke(12 months after index PCI (±30 days))
- Incidence of Unplanned Ischemia-Driven Revascularization(12 months after index PCI (±30 days))
- Rehospitalization for Unstable Angina(12 months after index PCI (±30 days))