Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study (HANYANG-PICK)

Hanyang University Seoul Hospital

Status and phase: Not yet enrolling; Phase 4

Conditions: Coronary Artery Disease

Treatments: Drug: Standard Lipid-Lowering Therapy; Drug: PCSK9 inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT07084259

HYUH 2025-02-018-004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 352 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

352 participants in 2 patient groups

PCSK9 Inhibitor Group

Experimental group

Description:

Patients with elevated post-PCI LCBI receiving a single subcutaneous dose of a PCSK9 inhibitor (evolocumab 140 mg) after percutaneous coronary intervention.

Treatment:

Drug: PCSK9 inhibitor

Standard of Care Group

Active Comparator group

Description:

Patients receiving standard post-PCI treatment without PCSK9 inhibitor therapy. Lipid-lowering therapy is managed according to current clinical guidelines.

Treatment:

Drug: Standard Lipid-Lowering Therapy