A Phase 4 interventional study of PCSK9 inhibitor and Standard Lipid-Lowering Therapy in Coronary Artery Disease, sponsored by Hanyang University Seoul Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2025-07-24.
Sponsored by Hanyang University Seoul Hospital · Phase 4, Interventional, and Treatment
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.
4,857 studies on the registry are indexed under Coronary Artery Disease; 890 are open to participants now.
This study's planned enrollment of 352 is above the median of 124 across 3,006 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Hanyang University Seoul Hospital is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
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Life expectancy
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Investigational drug or device
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It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
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Contraindication
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Patients with elevated post-PCI LCBI receiving a single subcutaneous dose of a PCSK9 inhibitor (evolocumab 140 mg) after percutaneous coronary intervention.
Drug: PCSK9 inhibitor
Patients receiving standard post-PCI treatment without PCSK9 inhibitor therapy. Lipid-lowering therapy is managed according to current clinical guidelines.
Drug: Standard Lipid-Lowering Therapy
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).
Also known as: Evolocumab (Repatha)
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.
Also known as: Statins ± Ezetimibe
Patient-oriented Composite Outcome (MACE)
Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.
Time frame: 12 months
No study locations are listed for this record.
Plan to share: Yes — De-identified individual participant data (IPD) will be made available upon reasonable request to qualified researchers. The data will be made available following publication of the primary results upon request and will be available for 5 years.
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: IPD and supporting information will be available beginning 12 months after publication of the primary results and will remain available for up to 5 years, contingent upon approval by the HANYANG-PICK Steering Committee.
Access criteria: Access to the de-identified individual participant data (IPD) and supporting documents will be granted to qualified researchers who submit a methodologically sound proposal, as determined by the HANYANG-PICK Steering Committee. The proposed research must be for non-commercial, academic purposes. Requestors will be required to sign a data use agreement and obtain appropriate ethical approvals before accessing the data.
Start is estimated for Jul 2025; primary completion for Jun 2030, 59 months later.
Of 180 non-industry phase 4 interventional studies under Coronary Artery Disease, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 21 and three quarters within 59. This study's planned 59 months is above that.
Counting every sponsor, half of 193 studies reached it within 35 months; a quarter within 19 and three quarters within 58.
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This study is not yet recruiting, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: PCSK9 Inhibitor
Hanyang University Seoul Hospital