[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypertriglyceridaemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypertriglyceridaemia":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,57,85],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":44,"whyStopped":4,"lastUpdateSubmitDate":45,"lastUpdatePostDateStruct":46,"startDateStruct":49,"completionDateStruct":51,"leadSponsor":53,"locationsCount":56},"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":21,"type":22},100,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29,30,31],"Coronary Artery Disease","Hyperlipidaemia","Hypertriglyceridaemia","Coronary Atherosclerosis",[33,34,35,36,31,37,38,39,40,41,42,43],"Icosapent Ethyl","IPE","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":47,"type":48},"2026-08-13","ACTUAL",{"date":50,"type":22},"2026-08-01",{"date":52,"type":22},"2029-12-31",{"name":54,"class":55},"China National Center for Cardiovascular Diseases","OTHER_GOV",1,{"id":58,"slug":59,"hasResults":11,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":65,"targetDuration":4,"studyType":23,"phases":67,"briefSummary":69,"conditions":70,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100636168","pemafibrate-for-symptomatic-icas-rct-100636168","NCT07562178","Pemafibrate for Symptomatic ICAS RCT","Triglyceride-lowering Therapy With Pemafibrate for Prevention of Atherosclerotic Cardiovascular Disease in Patients With Symptomatic Intracranial Artery Stenosis: a Multi-center, Open-label, Randomized Controlled Trial (PPAR-ICAS)","PPAR-ICAS","Inclusion Criteria:\n\n1. Clinically stable ischemic stroke or high-risk TIA (ABCD2 score \\>=4) between 24 hours and 3 years from onset at enrollment.\n2. Contrast-enhanced CT angiography (CTA) within 3 months prior to consent demonstrating 50-99% stenosis (WASID criteria) in a symptomatic intracranial artery: intracranial internal carotid artery, middle cerebral artery (M1\u002FM2), anterior cerebral artery (A1), vertebral artery (V4), basilar artery, or posterior cerebral artery (P1).\n3. Fasting triglycerides (TG) 150-499 mg\u002FdL, or non-fasting TG 175-499 mg\u002FdL, measured within 4 weeks prior to consent.\n4. Men or women aged \\>=18 years at the time of consent.\n5. Ability to obtain written informed consent from the patient or a legally authorized representative.\n\nExclusion Criteria:\n\n1. Patients with intracranial arterial stenosis due to non-atherosclerotic disorders (e.g., vasculitis, moyamoya disease, intracranial arterial dissection).\n2. Patients with \\>=70% stenosis of the extracranial carotid artery (NASCET criteria).\n3. Patients with neurological deterioration within 24 hours prior to enrollment.\n4. Patients who received intravenous thrombolysis or mechanical thrombectomy within 24 hours prior to enrollment.\n5. Patients scheduled to undergo revascularization procedures (percutaneous transluminal angioplasty, stent placement, carotid endarterectomy, or cerebral bypass surgery).\n6. Patients who meet any contraindication to pemafibrate, including:\n\n(1) History of hypersensitivity to pemafibrate; (2) Severe hepatic impairment or liver cirrhosis classified as Child-Pugh B or C; (3) Cholelithiasis; (4) Pregnancy or suspected pregnancy; (5) Concomitant use of cyclosporine or rifampin. 7. Patients who have taken pemafibrate or any fibrate within 12 weeks prior to consent.\n\n8\\. Patients with contraindications to iodinated contrast media. 9. Patients on dialysis. 10. Patients with a history of pancreatitis attributable to hypertriglyceridemia.\n\n11\\. Patients with severe systemic comorbidities with an expected survival \\\u003C12 months.\n\n12\\. Patients who may be pregnant, are pregnant, or are breastfeeding. 13. Any other condition for which the principal or sub-investigator judges participation to be inappropriate.",{"count":66,"type":22},270,[68],"NA","The goal of this clinical trial is to learn whether pemafibrate can help prevent worsening of intracranial arterial stenosis (ICAS) in patients who have symptomatic ICAS and high triglycerides (TG) levels after ischemic stroke or transient ischemic attack (TIA).\n\nThe main questions this study aims to answer are:\n\n1. Does pemafibrate lower the chance that ICAS gets worse over 12 months?\n2. Does pemafibrate improve TG levels and other vascular risk markers?\n3. What are the effects of pemafibrate on vascular events, functional outcomes, and safety over 12 months?\n\nResearchers will compare a pemafibrate group with a non-pemafibrate group to see whether pemafibrate helps prevent progression of ICAS. This is an open-label, randomized, parallel-group trial. That means participants are assigned by chance to 1 of 2 groups, and both the researchers and participants know which group was assigned. Participants in both groups will continue to receive standard stroke care, including antithrombotic therapy and management of vascular risk factors such as blood pressure, low-density lipoprotein cholesterol, diabetes, and smoking.\n\nParticipants may be eligible if they are 18 years or older, have clinically stable ischemic stroke or TIA, have 50% to 99% stenosis in a symptomatic intracranial artery on contrast-enhanced CT angiography (CTA), and have elevated fasting (\\>=150 mg\u002FdL) or non-fasting (\\>=175 mg\u002FdL) TG levels. Some people will not be eligible, such as those with ICAS due to non-atherosclerotic arterial disease, severe extracranial carotid stenosis, recent intravenous thrombolysis or mechanical thrombectomy, planned revascularization, contraindications to pemafibrate or iodinated contrast media, dialysis, or pregnancy.\n\nParticipants will:\n\n* Be randomly assigned to a pemafibrate group or a non-pemafibrate group\n* Take pemafibrate for 12 months if assigned to the pemafibrate group, with possible dose adjustment based on TG levels and kidney function\n* Have blood tests and clinical assessments at baseline and during follow-up\n* Undergo brain CTA at study entry and again at 12 months\n* Undergo brain MRI\u002FMRA and vascular tests such as ankle brachial index, cardio ankle vascular index, and pulse wave velocity according to the study schedule\n* Be followed for vascular events, functional outcome, and adverse events for 1 year",[71,30,72],"Intracranial Atherosclerotic Disease (ICAD)","Stroke (CVA) or TIA","RECRUITING","2026-07-30",{"date":76,"type":48},"2026-08-03",{"date":78,"type":48},"2026-05-26",{"date":80,"type":22},"2028-12-31",{"name":82,"class":83},"Tokyo Women's Medical University","OTHER",37,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":4,"eligibilityCriteria":91,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":92,"targetDuration":4,"studyType":94,"phases":4,"briefSummary":95,"conditions":96,"keywords":4,"overallStatus":73,"whyStopped":4,"lastUpdateSubmitDate":97,"lastUpdatePostDateStruct":98,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":56},"100224113","abnormal-lipids---causes-and-effects-100224113","NCT02195050","Abnormal Lipids - Causes and Effects","Hypertriglyceridaemia: Therapeutic Targets, Genetic Causes, and Associated Neuropathy","Inclusion Criteria:\n\n* Therapeutic target arm\n\n  * Statin treated patients with and without hypertriglyceridemia.\n  * Statin treated patients with type 2 diabetes.\n  * Statin treated patients with CKD stages 4 and 5.\n* Nerve function arm\n\n  •Patients known to have severe hypertriglyceridaemia (defined as triglyceride \\>5.5 mmol\u002Fl) but not known to have diabetes and matched controls.\n* Genetic screening arm\n\n  * Patients with a documented triglyceride level of more than 10 mmol\u002Fl at any time.\n  * Criteria for screening for FH and LAL deficiency include non-obese patients (BMI \\\u003C30) with low HDL-C (\\\u003C1.0 mmol\u002Fl male and \\\u003C1.3 mmol female), high triglycerides \\>1.7 mmol\u002Fl, high total cholesterol \\>6.2 or LDL cholesterol \\>4.7 mmol\u002Fl; patients with raised liver alanine aminotransferase (ALT) (1.5 x above ULN) but no metabolic or viral disease or alcohol excess and patients diagnosed with NAFLD with or without hyperlipidaemia.\n\nExclusion Criteria:\n\n* Pregnant and\u002For breast-feeding women.\n* Significant liver impairment.\n* Patients known to have active malignant disease.\n* Patients treated with medications that could affect lipoprotein metabolism significantly (like atypical antipsychotics, chemotherapy).\n* Untreated hypothyroid and hyperthyroidism (if treated and TFT normal could be recruited).",{"count":93,"type":22},1396,"OBSERVATIONAL","1. At target LDL-C levels, apoB100 concentrations will be higher than recommended levels in the following populations:\n\n   1. Tertiary centre lipid clinic patients with raised TG treated with statins.\n   2. Patients with type 2 diabetes treated with statins.\n   3. Patients with Chronic Kidney disease (CKD) stages 4 and 5 treated with statins.\n2. Despite achieving LDL-C and non-HDL-C targets, a significant number of statin-treated patients have residual cardiovascular risk related to raised hsCRP. The relationship between hsCRP and Lp-PLA2 (markers of inflammation) and LDL particle number measured by apoB100 is stronger than that of measured and calculated LDL and non-HDL. In statin treated patients there will be higher levels of hs-CRP and Lp-PLA2 in patients achieving LDL targets but not apo B targets.\n3. We hypothesise that non-diabetic patients with severe hypertriglyceridaemia (fasting serum triglyceride \\>5.5 mmol\u002Fl) have evidence of greater nerve damage compared with matched controls.\n4. LAL deficiency is underdiagnosed in patients with severe hypertriglyceridaemia, low HDL-C, hyperlipidaemias, non alcoholic fatty liver disease and idiopathic high liver enzymes.",[30],"2023-05-30",{"date":99,"type":48},"2023-05-31",{"date":101,"type":48},"2014-01-23",{"date":103,"type":22},"2030-12",{"name":105,"class":55},"Manchester University NHS Foundation Trust"]