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Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
Sponsor: Hanyang University Seoul Hospital
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.
Official title: HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
Key Details
Gender
All
Age Range
19 Years - Any
Study Type
INTERVENTIONAL
Enrollment
352
Start Date
2025-07
Completion Date
2030-07
Last Updated
2025-07-24
Healthy Volunteers
No
Conditions
Interventions
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).
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.