Coronary Artery DiseasePhase 4HANYANG-PICKNCT07084259
Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
A Phase 4 study testing PCSK9 inhibitor and Standard Lipid-Lowering Therapy in people with Coronary Artery Disease, run by Hanyang University Seoul Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- PCSK9 inhibitor and Standard Lipid-Lowering Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- No sites listed yet
- Study dates
- Jul 2025to Jul 2030
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
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.
Read the 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
- Being tested
- PCSK9 inhibitor, Standard Lipid-Lowering Therapy
- Keywords
- PCSK9 Inhibitor, Near-Infrared Spectroscopy (NIRS), Intravascular Ultrasound (IVUS), Vulnerable Plaque, Evolocumab
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCSK9 inhibitorDrug
Also called Evolocumab (Repatha)
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).
Standard Lipid-Lowering TherapyDrug
Also called Statins ± Ezetimibe
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Standard Lipid-Lowering Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-oriented Composite Outcome (MACE)
Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2025
- Study startJul 2025 (estimated)
- Primary completionJun 2030 (estimated)
- Study completionJul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 352 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hanyang University Seoul Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- DOTTER Inc.
- Responsible party
- Principal investigator, Woohyeun Kim, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07084259
- Sponsor's protocol ID
- HYUH 2025-02-018-004
- Acronym
- HANYANG-PICK
- Status last verified
- Jul 2025
- First submitted
- 16 Jul 2025
- Last updated
- 24 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Kim W, Park S, Shin JH, Kook H, Lim YH. Proactive, short-term PCSK9 inhibition after PCI in patients with coronary artery disease at high residual risk: rationale and design of the randomized HANYANG-PICK trial. Front Cardiovasc Med. 2026 Mar 2;13:1761093. doi: 10.3389/fcvm.2026.1761093. eCollection 2026.
PubMed 41847515
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
- ClinicalTrials.gov ID
- NCT07084259
- Acronym / sponsor ID
- HANYANG-PICK / HYUH 2025-02-018-004
- Conditions
- Coronary Artery Disease
- Keywords
- PCSK9 Inhibitor, Near-Infrared Spectroscopy (NIRS), Intravascular Ultrasound (IVUS), Vulnerable Plaque, Evolocumab
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 352 participants (estimated)
- Lead sponsor
- Hanyang University Seoul HospitalUniversity, hospital or other
- Collaborators
- DOTTER Inc.
- Study start
- Jul 2025 (estimated)
- Primary completion
- Jun 2030 (estimated)
- Study completion
- Jul 2030 (estimated)
- First posted
- 24 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| PCSK9 Inhibitor Group | Experimental | Drug: PCSK9 inhibitorPatients 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 TherapyPatients receiving standard post-PCI treatment without PCSK9 inhibitor therapy. Lipid-lowering therapy is managed according to current clinical guidelines. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PCSK9 inhibitorAlso: Evolocumab (Repatha)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 | PCSK9 Inhibitor Group |
| Standard Lipid-Lowering TherapyAlso: Statins ± EzetimibeLipid-lowering therapy with high-intensity or maximally tolerated statins with or without ezetimibe, as per current clinical guidelines, excluding the use of PCSK9 inhibitors. | Drug | Standard of Care Group |
Primary outcome
Patient-oriented Composite Outcome (MACE)
Time frame: 12 months
Composite of all-cause mortality, any myocardial infarction, any stroke, or any clinically driven revascularization.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Derived from this study: PubMed 41847515Kim W, Park S, Shin JH, Kook H, Lim YH. Proactive, short-term PCSK9 inhibition after PCI in patients with coronary artery disease at high residual risk: rationale and design of the randomized HANYANG-PICK trial. Front Cardiovasc Med. 2026 Mar 2;13:1761093. doi: 10.3389/fcvm.2026.1761093. eCollection 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing PCSK9 inhibitor and Standard Lipid-Lowering Therapy in people with Coronary Artery Disease, run by Hanyang University Seoul Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 24 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Woohyeun Kim, MD, PhD (+82-2-2290-8310, coincidence1@naver.com; coincide@hanyang.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-oriented Composite Outcome (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07084259, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2025.