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Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET/CT

Study acronym: IPE-NaF
StatusNot Yet Recruiting
PhasePhase 4
Started2026-08-01
View on ClinicalTrials.gov ↗
This randomized controlled study will evaluate whether icosapent ethyl (IPE) can improve and stabilize high-risk coronary plaques in patients receiving stable low-density lipoprotein cholesterol (LDL-C)-lowering therapy. Potential participants will have coronary plaques identified by coronary computed tomography angiography (CCTA), with 30% to 70% narrowing in at least one major coronary artery and at least one high-risk plaque feature. After baseline imaging with fluorine-18 sodium fluoride positron emission tomography/computed tomography (18F-NaF PET/CT), eligible participants will be randomly assigned in a 1:1 ratio to receive either IPE 2 g twice daily plus standard LDL-C-lowering therapy or standard LDL-C-lowering therapy alone for 12 months. At the end of treatment, participants will undergo repeat CCTA and 18F-NaF PET/CT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.
Trial Details
NCT Number NCT07762755
Lead Sponsor China National Center for Cardiovascular Diseases
Collaborators: Beijing Anzhen Hospital, Beijing Chao Yang Hospital, Beijing Municipal Health Commission
Conditions Coronary Artery Disease, Hyperlipidaemia, Hypertriglyceridaemia, Coronary Atherosclerosis
Enrollment 100 participants
Start Date 2026-08-01
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-08-13