[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100651536":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":35,"locations":45,"responsibleParty":66,"collaborators":68,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":34,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":99,"overallStatus":110,"whyStopped":34,"lastUpdateSubmitDate":111,"lastUpdatePostDateStruct":112,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},{"fullName":5,"class":6},"China National Center for Cardiovascular Diseases","OTHER_GOV",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Icosapent Ethyl Plus Standard LDL-C-Lowering Therapy","EXPERIMENTAL","Participants will receive oral icosapent ethyl 2 g twice daily for 12 months in addition to their stable LDL-C-lowering therapy. CCTA and 18F-NaF PET\u002FCT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.",[13,14],"Drug: icosapent ethyl (IPE)","Drug: Standard LDL-C-Lowering Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard LDL-C-Lowering Therapy Alone","ACTIVE_COMPARATOR","Participants will continue their stable LDL-C-lowering therapy for 12 months without receiving icosapent ethyl. CCTA and 18F-NaF PET\u002FCT will be performed at baseline and after 12 months, together with biomarker and clinical event follow-up.",[14],[21,30],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","icosapent ethyl (IPE)","Icosapent ethyl will be administered orally at a dose of 2 g twice daily (total daily dose of 4 g) for 12 months, in addition to stable LDL-C-lowering therapy.",[9],[27,28,29],"IPE","Ethyl Eicosapentaenoate","Eicosapentaenoic Acid Ethyl Ester",{"type":22,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Standard LDL-C-Lowering Therapy","Participants will continue an individualized, stable LDL-C-lowering regimen throughout the 12-month study period. The LDL-C-lowering regimen must have remained stable for more than 4 weeks before randomization. This background therapy will be administered in both study arms.",[9,16],null,[36,41],{"name":37,"role":38,"phone":39,"phoneExt":34,"email":40},"Naqiong Wu, Doctor","CONTACT","+86 13501139869","fuwainaqiongwu@163.com",{"name":42,"role":38,"phone":43,"phoneExt":34,"email":44},"Zheng Yin, Master","+8615359270767","yinzheng@fuwai.com",[46],{"facility":47,"status":34,"city":48,"state":49,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"Fuwai Hospital","Beijing","Beijing Municipality","100037","China","CN",{"type":54,"coordinates":55},"Point",[56,57],116.39723,39.9075,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":34,"email":63},"Jianing Zhang, Master","+86 (010) 88398662","Zhangjianing@fuwai.com",{"name":37,"role":65,"phone":34,"phoneExt":34,"email":34},"PRINCIPAL_INVESTIGATOR",{"type":67,"investigatorFullName":34,"investigatorTitle":34,"investigatorAffiliation":34,"oldNameTitle":34,"oldOrganization":34},"SPONSOR",[69,72,74],{"name":70,"class":71},"Beijing Anzhen Hospital","OTHER",{"name":73,"class":71},"Beijing Chao Yang Hospital",{"name":75,"class":6},"Beijing Municipal Health Commission","100651536","phase-4-icosapent-ethyl-for-high-risk-coronary-plaques-assessed-by-18f-naf-petct-100651536",false,"NCT07762755","Icosapent Ethyl for High-Risk Coronary Plaques Assessed by 18F-NaF PET\u002FCT","A Randomized Controlled Trial Evaluating the Effect of Icosapent Ethyl on High-Risk Coronary Plaques Using 18F-Sodium Fluoride PET\u002FCT","IPE-NaF","Inclusion Criteria:\n\n* Male or female participants aged 18 to 75 years.\n* Ability to understand the study and provide written informed consent before enrollment.\n* Receiving a stable lipid-lowering regimen before enrollment, with the type and dose of statin therapy remaining unchanged for at least 4 weeks.\n* Fasting triglyceride level below 5.6 mmol\u002FL.\n* Presence of at least one of the following high-risk plaque features on coronary computed tomography angiography (CCTA):Pericoronary fat attenuation index greater than -70.1 Hounsfield units;\n* Low-attenuation plaque below 30 Hounsfield units;\n* Positive remodeling index greater than 1.1;\n* Spotty calcification;\n* or Napkin-ring sign, defined as a low-attenuation plaque core surrounded by a rim of higher attenuation.\n\nExclusion Criteria:\n\n* Current participation in another investigational drug, device, or procedure study, or receipt of an investigational drug or device within 4 weeks before enrollment.\n* Treatment with icosapent ethyl within 12 months before enrollment.\n* Known intolerance or hypersensitivity to icosapent ethyl or fish oil.\n* A previous diagnosis of homozygous familial hypercholesterolemia or hyperlipidemia requiring hemodialysis.\n* Myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass grafting, or stroke within 3 months before enrollment;\n* Planned cardiac surgery, percutaneous coronary intervention, or carotid artery stenting, or planned major noncardiac surgery during the study.\n* A known contraindication or limitation to PET\u002FCT, including exceeding scanner weight limits or having a device, carotid or aortic stent, or vascular graft that may cause imaging artifacts.\n* Autoimmune disease, vasculitis, or active inflammatory disease.\n* Serious infection within 1 month before enrollment or a current infection requiring intravenous antibiotic treatment.\n* Use within 6 weeks before enrollment or current use of medications that may significantly affect plaque inflammation, including oral, rectal, or injectable corticosteroids or immunosuppressive agents, such as cyclosporine, methotrexate, tacrolimus, azathioprine, antithymocyte globulin, sirolimus, anti-tumor necrosis factor agents such as infliximab, anti-interleukin-6 therapy such as tocilizumab, or anti-interleukin-1 therapy.\n* Use within 6 weeks before enrollment or current use of aspirin at a dose greater than 325 mg\u002Fday or nonsteroidal anti-inflammatory drugs at a dose greater than 1,000 mg\u002Fday.\n* Treatment within 12 months before enrollment with a cholesteryl ester transfer protein inhibitor, including anacetrapib, dalcetrapib, or evacetrapib, or with mipomersen or lomitapide.\n* Known clinically significant systemic disease, including hepatic, renal, hematologic, or malignant disease, or any other clinically significant comorbidity that may interfere with study participation or study assessments.\n* History of malignancy within the previous 5 years, except nonmelanoma skin cancer, cervical carcinoma in situ, ductal carcinoma in situ of the breast, or stage I prostate cancer.\n* Inability or anticipated inability to complete all protocol-required visits or procedures, or any condition that may make the participant unreliable for study participation, including alcohol or other substance abuse within the previous year or a psychiatric disorder.\n* Pregnancy or breastfeeding, or plans to become pregnant or breastfeed during study treatment or within 15 weeks after the last dose of study treatment.","ALL","18 Years","75 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","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.\n\nAfter baseline imaging with fluorine-18 sodium fluoride positron emission tomography\u002Fcomputed tomography (18F-NaF PET\u002FCT), 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\u002FCT. Blood biomarkers and major adverse cardiovascular events will also be assessed during follow-up.",[95,96,97,98],"Coronary Artery Disease","Hyperlipidaemia","Hypertriglyceridaemia","Coronary Atherosclerosis",[100,27,101,102,98,103,104,105,106,107,108,109],"Icosapent Ethyl","High-Risk Coronary Plaque","Coronary Plaque Stabilization","Intermediate Coronary Stenosis","18F-Sodium Fluoride PET\u002FCT","18F-NaF PET\u002FCT","Coronary Computed Tomography Angiography","CCTA","Coronary Microcalcification","Pericoronary Fat Attenuation Index","NOT_YET_RECRUITING","2026-08-11",{"date":113,"type":114},"2026-08-13","ACTUAL",{"date":116,"type":89},"2026-08-01",{"date":118,"type":89},"2029-12-31",{"name":5,"class":6},1]