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Comparison of Moderate-Intensity Statin Plus Ezetimibe vs. High-Intensity Statin for Coronary Plaque Stabilization

StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary endpoint reworded 1 of 1 changed
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Record History

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  1. Primary endpoint(s) modified Show 7 more changesShow less
    • Enrollment closed, study ongoing
    • Trial sites expanded: 1 → 7 locations
    • Primary completion moved earlier from Jan 25, 2028 to Nov 2027
    • Interventions modified
    • Eligibility criteria expanded, about 29 words
    • Secondary endpoints: 3 to 16
    • Publications: details revised at 7 of 7 entries
  2. Enrollment target: 330 to 408
    • Eligibility criteria expanded, about 6 words
    • Publications: details revised at 7 of 7 entries
    v3
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 25, 2025 to May 12, 2025
    • Study sites: 0 to 1
    v2
  4. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This study is a prospective, multicenter, randomized clinical trial aimed at comparing the effects of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy on coronary plaque stabilization. Using advanced imaging techniques such as near-infrared spectroscopy-intravascular ultrasound (NIRS-IVUS), the trial evaluates whether the combination therapy is non-inferior to monotherapy in stabilizing coronary plaques over 52 weeks. The primary endpoint is the change in percent atheroma volume (PAV) from baseline to week 52, assessed by grayscale IVUS. Secondary outcomes include changes in lipid core burden, inflammatory markers, and clinical events like myocardial infarction and ischemic stroke. Seven hospitals participated in the study. A total of 408 participants were enrolled at six sites; no participants were enrolled at Inje University Ilsan Paik Hospital. Follow-up is ongoing.
Trial Details
NCT Number NCT06767345
Lead Sponsor Korea University Anam Hospital
Collaborators: Yuhan Corporation, Hanmi Pharmaceutical co., ltd.
Conditions
(from sponsor)		 Coronary Artery Disease, Atherosclerosis of Coronary Artery, Plaque, Atherosclerotic
Related terms Coronary Artery Disease, Plaque, Atherosclerotic
Enrollment 408 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov