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

Phase 4Not Yet RecruitingNCT07084259

Hanyang University Seoul Hospital352 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

352

Conditions

Coronary Artery Disease

Interventions

PCSK9 inhibitorDRUG

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).

Standard Lipid-Lowering TherapyDRUG

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Outcomes

Primary Outcomes

Patient-oriented Composite Outcome (MACE)

Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.

Time frame: 12 months

Central Contacts

Woohyeun Kim, MD, PhD

CONTACT

+82-2-2290-8310 coincidence1@naver.com; coincide@hanyang.ac.kr

Data from ClinicalTrials.gov

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