HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 352
- 主要终点
- Patient-oriented Composite Outcome (MACE)
研究概览
简要总结
This pilot study aims to evaluate whether a single dose of PCSK9 inhibitor administered after percutaneous coronary intervention (PCI) can improve long-term cardiovascular outcomes in patients with high post-PCI lipid core burden, as assessed by NIRS-IVUS. The study will assess major adverse cardiovascular events (MACE) over a 12-month follow-up period.
详细描述
Coronary artery disease (CAD) remains a leading cause of death worldwide, and while PCI has improved clinical outcomes, residual cardiovascular risk persists, especially in patients with lipid-rich plaques. Near-infrared spectroscopy combined with intravascular ultrasound (NIRS-IVUS) allows for the detection of lipid core burden, and high post-PCI LCBI values have been associated with worse prognosis.
This single-center, prospective, randomized pilot study (HANYANG-PICK) investigates the impact of a single dose of PCSK9 inhibitor administered immediately after PCI in patients with high post-PCI LCBI. The intervention group will receive the PCSK9 inhibitor, and the control group will undergo standard therapy. The primary endpoint is the incidence of major adverse cardiovascular events (MACE) at 12 months. The study is designed to inform the feasibility of a larger trial and to explore the potential of PCSK9 inhibitors for early plaque stabilization post-PCI.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 19 years or older
- •Patients diagnosed with coronary artery disease, including silent ischemia, stable angina, or acute coronary syndrome (unstable angina, NSTEMI, or STEMI)
- •Underwent percutaneous coronary intervention (PCI) with NIRS-IVUS imaging
- •Presence of target vessel post-PCI maxLCBI4mm ≥ 200
- •Able and willing to provide written informed consent
排除标准
- •Cardiogenic shock or hemodynamic instability within 24 hours prior to enrollment
- •Expected life expectancy <1 year
- •Participation in another investigational study that may interfere with the results
- •Known contraindications to PCSK9 inhibitors or standard-of-care lipid-lowering therapy
研究组 & 干预措施
PCSK9 Inhibitor Group
Patients with elevated post-PCI LCBI receiving a single subcutaneous dose of a PCSK9 inhibitor (evolocumab 140 mg) after percutaneous coronary intervention.
干预措施: PCSK9 inhibitor (Drug)
Standard of Care Group
Patients receiving standard post-PCI treatment without PCSK9 inhibitor therapy. Lipid-lowering therapy is managed according to current clinical guidelines.
干预措施: Standard Lipid-Lowering Therapy (Drug)
结局指标
主要结局
Patient-oriented Composite Outcome (MACE)
时间窗: 12 months
Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.
次要结局
未报告次要终点
研究者
Woohyeun Kim
Associate Professor, Division of Cardiology, Department of Internal Medicine
Hanyang University