NCT07084259

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 352 (estimated)
• Sponsor: Hanyang University Seoul Hospital · Academic / Other
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
DRUG	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).
DRUG	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.

Timeline

• Start date: 2025-07-01
• Primary completion: 2030-06-01
• Completion: 2030-07-01
• First posted: 2025-07-24
• Last updated: 2025-07-24