HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
| Registry | NCT07084259, acronym HANYANG-PICK |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 352 (Estimated) |
| Sponsor | Hanyang University Seoul Hospital (Other); collaborators: DOTTER Inc. |
| Conditions | Coronary Artery Disease |
| Interventions | PCSK9 inhibitor, Standard Lipid-Lowering Therapy (Drug) |
| Dates | start 2025-07-01 (estimated), primary completion 2030-06-01 (estimated), completion 2030-07-01 (estimated), first posted 2025-07-24, last updated 2025-07-24 |
Related Papers Related Patents Related Grants Related Experts
All trials for Coronary Artery Disease All trials of PCSK9 inhibitor All trials of Standard Lipid-Lowering Therapy
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| PCSK9 Inhibitor Group | Experimental | Drug: PCSK9 inhibitor | Patients with elevated post-PCI LCBI receiving a single subcutaneous dose of a PCSK9 inhibitor (evolocumab 140 mg) after percutaneous coronary intervention. |
| Standard of Care Group | Active comparator | Drug: Standard Lipid-Lowering Therapy | Patients receiving standard post-PCI treatment without PCSK9 inhibitor therapy. Lipid-lowering therapy is managed according to current clinical guidelines. |
Sex: All, ages: 19 Years to any
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