Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study

Официальное название

HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат PCSK9 inhibitor
  Single dose of subcutaneous administration of PCSK9 inhibitors (evolocumab) after PCI in patients with coronary artery disease and elevated post-PCI lipid core burden (maxLCBI4mm ≥ 200).
• Препарат Standard Lipid-Lowering Therapy
  Lipid-lowering therapy with high-intensity or maximally tolerated statins with or without ezetimibe, as per current clinical guidelines, excluding the use of PCSK9 inhibitors.

Первичные конечные точки

• Patient-oriented Composite Outcome (MACE) [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Kim W, Park S, Shin JH, Kook H, Lim YH. Proactive, short-term PCSK9 inhibition after PCI in patients with coronary artery disease at high residual risk: rationale and design of the randomized HANYANG-PICK trial. Front Cardiovasc Med. 2026 Mar 2;13:1761093. doi: 10.3389/fcvm.2026.1761093. eCollection 2026. PMID 41847515

Идентификаторы

NCT: NCT07084259 · HYUH 2025-02-018-004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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