NCT07084259Not yet recruitingPhase 4
Single Dose PCSK9 Inhibitor to Improve Cardiovascular Outcomes After PCI: A Pilot Study
HArnessing Near-infrared Spectroscopy Intravascular Ultrasound Imaging for Yielding Advanced Guidance - PCSK9i for Improving Cardiovascular Outcome in High-Risk Patients
Source: ClinicalTrials.gov · Last updated 24 Jul 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 352 (estimated)
- First submitted
- 16 Jul 2025
- Start date
- 1 Jul 2025
- Primary completion date
- 30 Jun 2030
- Lead sponsor
- Hanyang University Seoul Hospital
- Diseases
- Coronary artery disease
- NCT number
- NCT07084259
What you commit to
- Study type: Interventional · Phase 4
- Planned participants: 352
- From 1 Jul 2025 to the primary completion date, 30 Jun 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Cardiogenic shock or hemodynamic instability within 24 hours prior to enrollment
- Known contraindications to PCSK9 inhibitors or standard-of-care lipid-lowering therapy
Other
- Expected life expectancy \<1 year
- Participation in another investigational study that may interfere with the results
Who the study is looking for
- 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
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.