Assessing Coronary Non-Culprit Plaque Early with Start of PCSK9 Inhibitors in Acute Myocardial Infarction
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.
研究概览
简要总结
This study is planned to start on January 2024.
The goal of this clinical trial is to learn whether the perioperative administration (within 24 hours before or after primary PCI) of PCSK9 inhibitors can ameliorate plaque progression and adverse outcomes in patients with acute myocardial infarction (AMI). The main questions it aims to answer are:
Can perioperative PCSK9 inhibition improve the plaque stability and inflammation of perivascular adipose tissue (index of plaque attenuation（IPA ）and perivascular fat attenuation index（FAI）) of non-target lesions? Researchers will compare PCSK9 inhibitors with statin plus ezetimibe therapy to evaluate the potential of PCSK9 inhibitors in mitigating the progression of non-target lesion plaques and reducing adverse cardiovascular events in patients with AMI.
Participants will:
Take PCSK9 inhibitors every two weeks or daily statin plus ezetimibe therapy. Conduct a follow-up examination with optical coherence tomography (OCT) or coronary computed tomography angiography (CTA) after 12 months.
Record the occurrence of major adverse cardiovascular events.
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 old.
- •Admitted to hospital for acute myocardial infarction (STEMI, NSTEMI) and successfully underwent PCI of the infarct vessel.
- •Coronary angiography revealed two non-infarct-related arteries with non-blocking lesions (diameter stenosis of 40-70%).
- •Able to sign informed consent.
- •Willing to undergo 1-year follow-up.
排除标准
- •Left main artery disease or severe coronary artery calcification;
- •Hemodynamic instability or uncontrolled arrhythmia;
- •History of coronary artery bypass;
- •severe renal insufficiency, active liver disease or liver insufficiency, hematological disease, metabolic or endocrine dysfunction, systemic infection, active malignant tumor and other potentially life-threatening diseases, or the expected survival time is < 1 year;
- •Received any PCSK9 inhibitor treatment within the previous 3 months;
- •Pregnant or nursing women or women planning pregnancy;
- •The researcher determined that it was not suitable for inclusion in the group.
研究组 & 干预措施
PCSK9 inhibitor group
In this group, patients will receive PCSK9 inhibitor treatment
干预措施: PCSK9 inhibitor (Drug)
PCSK9 inhibitor group
In this group, patients will receive PCSK9 inhibitor treatment
干预措施: Blood lipid levels meet the recommended guidelines (Behavioral)
Statin+ezetimibe group
In this group, patients will receive statin and ezetimibe treatment
干预措施: Statin+ezetimibe (Drug)
Statin+ezetimibe group
In this group, patients will receive statin and ezetimibe treatment
干预措施: Blood lipid levels don't meet the recommended guidelines (Behavioral)
结局指标
主要结局
Changes in Index of Plaque Attenuation (IPA) measured by OCT for non-culprit lesions at baseline and 12 months of follow-up.
时间窗: 12 months
IPA is a quantitative analysis tool based on OCT technology to evaluate plaque stability.
Changes in pericoronary artery fat attenuation index (FAI) measured by CCTA for non-culprit lesions at baseline and 12 months of follow-up
时间窗: 12 months
FAI is a quantitative indicator of inflammation in perivascular adipose tissue measured by CCTA.
次要结局
- Progress of target lesion plaques(12 months)
- The overall incidence of the first major adverse cardiovascular events (MACEs) within 12 months in different treatment groups(12 months)
- The proportion of LDLC at each visit node that meets the recommended guidelines and the changes compared to baseline(1week；1months；3 months； 6 months; 9 months; 12 months)
- Changes in inflammatory factors (interleukin 6, C reaction protein) at each visit node compared to baseline(1week；1months；3 months； 6 months; 9 months; 12 months)
研究者
Yun Dai Chen
professor
Chinese PLA General Hospital