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

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.

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