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

NCT07084259 | Not Yet Recruiting Phase 4

• 1 other identifier: HYUH 2025-02-018-004
• Study Type: interventional
• Target: 352
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Coronary Artery Disease

Keywords

PCSK9 Inhibitor; Near-Infrared Spectroscopy (NIRS); Intravascular Ultrasound (IVUS); Vulnerable Plaque; Evolocumab

Outcome Measures

Primary Outcomes (1)

• Patient-oriented Composite Outcome (MACE)

  Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.

  12 months

Study Arms (2)

PCSK9 Inhibitor Group

EXPERIMENTAL

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

Standard of Care Group

ACTIVE COMPARATOR

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

Interventions

PCSK9 inhibitor DRUG

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)

PCSK9 Inhibitor Group

Standard Lipid-Lowering Therapy DRUG

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

Standard of Care Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hanyang University Seoul Hospital: lead
• DOTTER Inc.: collaborator

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

evolocumab

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Woohyeun Kim, MD, PhD

CONTACT

+82-2-2290-8310; coincidence1@naver.com; coincide@hanyang.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Division of Cardiology, Department of Internal Medicine

Model Details: Participants will be randomly assigned in a parallel manner to receive either a PCSK9 inhibitor (Evolocumab) in addition to standard therapy or standard therapy alone. The study aims to compare the long-term cardiovascular outcomes between the two groups.

Study Record Dates

• First Submitted: July 16, 2025
• First Posted: July 24, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): June 1, 2030
• Study Completion (Estimated): July 1, 2030
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.