Coronary Artery Disease
Conditions
Keywords
PCSK9 Inhibitor, Near-Infrared Spectroscopy (NIRS), Intravascular Ultrasound (IVUS), Vulnerable Plaque, Evolocumab
Brief summary
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.
Detailed description
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.
Interventions
DRUGPCSK9 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).
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.
Sponsors
DOTTER Inc.
Hanyang University Seoul Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Participants will be randomly assigned in a parallel manner to receive either a PCSK9 inhibitor (Evolocumab) in addition to standard therapy or standard therapy alone. The study aims to compare the long-term cardiovascular outcomes between the two groups.
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient-oriented Composite Outcome (MACE) | 12 months | Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization. |
Contacts
Primary ContactWoohyeun Kim, MD, PhD
Outcome results
None listed