[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"hypercholesterolemia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:hypercholesterolemia":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,34,0,25,[9,41,68,98,121,147,159,187,218,252,275,303,332,362,387,414,435,454,473,499,523,549,574,595,618],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100054138","phase-4-a-post-marketing-clinical-trial-of-pemafibrate-in-patients-ith-hypercholesterolemia-and-inadequate-response-to-statins-100054138",false,"NCT07634484","A Post-Marketing Clinical Trial of Pemafibrate in Patients ｗith Hypercholesterolemia and Inadequate Response to Statins","A Post-Marketing Clinical Trial of Pemafibrate in Patients With Hypercholesterolemia and Inadequate Response to Statins-Multicenter, Placebo Controlled, Randomized, Double Blind, Parallel Group Controlled Trial","Inclusion Criteria:Patients who meet all the following criteria shall be eligible for the clinical trial.\n\n1. Patients with hypercholesterolemia aged 18 years or older at the time of obtaining written informed consent\n2. Patients who have taken statins at a fixed dose and regimen within the approved dose range for at least four weeks prior to the first screening assessment.\n3. Patients who have received stable dietary and\u002For exercise therapy for at least 12 weeks prior to the first screening assessment.\n4. Patients with the fasting serum TG \\\u003C 150 mg\u002FdL on two consecutive occasions at screening\n5. Patients who apply any of the following risk category with LDL-C level (direct) based on JAS2022 on two consecutive occasions at screening\n\n   * Low risk for primary prevention: LDL-C \\>=160 mg\u002FdL\n   * Intermediate risk for primary prevention: LDL-C \\>=140 mg\u002FdL\n   * High risk for primary prevention: LDL-C\\>=120 mg\u002FdL or 100 mg\u002FdL\\*\n   * Secondary prevention: LDL-C\\>=100 mg\u002FdL\n   * Familial hypercholesterolemia (heterozygous): LDL-C\\>=100 mg\u002FdL\n\n     * For patients with diabetes, those with peripheral artery disease (PAD), microvascular complications (retinopathy, nephropathy, neuropathy), or current smoking are included if LDL-C\\>=100 mg\u002FdL.\n\nExclusion Criteria:Patients who meet any of the following criteria will be excluded from the clinical trial.\n\n1. Patients who require administration of prohibited drugs during the post-marketing clinical trial period after written informed consent\n2. Patients with type 1 diabetes and uncontrolled type 2 diabetes \\[HbA1c(NGSP) \\>= 10.0 % at Screening\\]\n3. Patients whose LDL-C level changed by more than +20% or -20% in the second screening test compared to the the first.\n4. Patients with uncontrolled thyroid disease\n5. Patients who are undergoing or are scheduled to undergo LDL apheresis\n6. Patients with cirrhosis or those with biliary obstruction\n7. Patients with gallstones\n8. Patients with familial hypercholesterolemia (homozygotes)\n9. Patients with impaired renal function (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m2 at screening)\n10. Patients with uncontrolled hypertension (SBP \\>= 160 mmHg or DBP \\>= 100 mmHg) at screening\n11. Patients with AST and ALT levels three times or greater than the upper limit of normal at screening\n12. Patients with CK levels at least three times the upper limit of normal at screening\n13. Patients with any of the following experiences within 3 months prior to informed consent: myocardial infarction, severe or unstable angina pectoris, coronary angioplasty, coronary artery bypass surgery, stroke, transient ischemic attack, symptomatic carotid artery stenosis, symptomatic peripheral arterial disease, abdominal aortic aneurysm, uncontrolled severe arrhythmia and decompensated heart failure\n14. Patients who plan to undergo PCI, CABG, carotid artery or peripheral revascularization\n15. Patients with heart failure class III or higher according to NYHA cardiac function classification\n16. Patients with malignant tumor or those who are judged to have a high risk of recurrence\n17. Patients with a history of myopathy or rhabdomyolysis due to pemafibrate\n18. Patients with a history of hypersensitivity due to pemafibrate\n19. Patients with a history of serious drug allergies (anaphylactic shock, etc.)\n20. Pregnant women, lactating women, women planning to become pregnant or lactating during the study period, or pregnant women of childbearing potential\\*2 who do not use specific contraceptive methods\\*1\n21. Patients who have undergone whole blood donation of 400 mL or more within 16 weeks, or 200 mL or more within 4 weeks, or component donation (plasma or platelet donation) within 2 weeks prior to screening.\n22. Patients with alcoholics or drug addicts\n23. Patients who participated in other clinical trials of a drug with new active ingredients within 16 weeks or a drug with an approved active ingredients within 12 weeks prior to administration and received an investigational drug other than placebo,or those who will participate in other clinical trials at the same time as the clinical trial\n24. Patients who are considered inappropriate for participation in this study by the investigator, etc\n\n    * 1 Acceptable contraceptive methods: Oral hormonal contraceptives (combination pills containing progestin and estrogen), intrauterine devices, intrauterine hormonal delivery systems, abstinence\n    * 2 Woman of childbearing potential refers to a woman who is physiologically capable of becoming pregnant with a male partner who has not undergone contraception. However, it does not apply if the investigator confirms that any of the following criteria is met.\n\n      * Patients with hysterectomy or tubal ligation before informed consent\n      * Post-menopausal women (those who have passed more than 1 year since their last menstrual period without other medical reasons).","ALL","18 Years",{"count":20,"type":21},120,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","To investigate the efficacy and safety of Pemafibrate 0.2 mg\u002Fday or 0.4 mg\u002Fday for 12 weeks in patients with hypercholesterolemia and inadequate response to statins, using placebo as a control.",[27],"Hypercholesterolemia","RECRUITING","2026-07-10",{"date":31,"type":32},"2026-07-13","ACTUAL",{"date":34,"type":21},"2026-07-01",{"date":36,"type":21},"2027-07-31",{"name":38,"class":39},"Kowa Company, Ltd.","INDUSTRY",10,{"id":42,"slug":43,"hasResults":12,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":54,"conditions":55,"keywords":56,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":59,"lastUpdatePostDateStruct":60,"startDateStruct":61,"completionDateStruct":63,"leadSponsor":65,"locationsCount":67},"100629671","phase-2-a-study-to-see-how-safe-and-effective-alirocumab-is-when-given-weekly-to-adult-participants-who-have-hypercholesterolemia-100629671","NCT07477704","A Study to See How Safe and Effective Alirocumab is When Given Weekly to Adult Participants Who Have Hypercholesterolemia","A Randomized, Open-Label, Dose-Ranging Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Weekly Alirocumab in Adults With Hypercholesterolemia","ASCEND-QW","Key Inclusion Criteria:\n\n1\\. Participant has elevated LDL-C level, as defined in the protocol\n\nKey Exclusion Criteria:\n\n1. Participant plans to initiate or change dose of lipid-lowering therapy\n2. Use of any PCSK9 inhibitors\n\nNOTE: Other Protocol-Defined Inclusion\u002FExclusion Criteria Apply","80 Years",{"count":51,"type":21},420,[53],"PHASE2","This study is researching an experimental drug called alirocumab, referred to as \"study drug\". In the United States, alirocumab is approved for the treatment of hypercholesterolemia (high blood cholesterol levels).\n\nThe aim of the study is to see how safe and effective alirocumab is when given weekly to adult participants who have hypercholesterolemia.\n\nThe study is looking at several other research questions, including:\n\n* What side effects may happen from taking the study drug once a week\n* How much study drug is in the blood at different times",[27],[57,58],"Obesity","Elevated Low-Density Lipoprotein Cholesterol (LDL-C) Levels","2026-06-30",{"date":34,"type":32},{"date":62,"type":32},"2026-06-17",{"date":64,"type":21},"2027-02-23",{"name":66,"class":39},"Regeneron Pharmaceuticals",6,{"id":69,"slug":70,"hasResults":12,"nctId":71,"briefTitle":72,"officialTitle":73,"acronym":4,"eligibilityCriteria":74,"healthyVolunteers":12,"sex":17,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":92,"completionDateStruct":4,"leadSponsor":94,"locationsCount":97},"100084203","causes-and-natural-history-of-dyslipidemias-100084203","NCT00353782","Causes and Natural History of Dyslipidemias","Disease Pathogenesis and Natural History of Lipid Disorders","* INCLUSION CRITERIA:\n* Children \\>= 2 years of age and \\>12 kg and adults\n* Dyslipidemia subjects of interest the group\n\nThe following is a representative list of the types of patient presentations with dyslipidemia and potential diagnoses eligible for this protocol:\n\n* Plasma cholesterol levels \\>200 mg\u002Fdl or \\\u003C120 mg\u002Fdl includes patients with diagnoses such as familial hypercholesterolemia, familial combined hyperlipidemia, sitosterolemia, lipoprotein lipase, hepatic lipase or apo-CII deficiency, and dysbetalipoproteinemia.\n* Plasma LDL-C levels \\>130 mg\u002Fdl or \\\u003C70 mg\u002Fdl includes patients with diagnoses such as familial hypercholesterolemia, PCSK9, apo3500, familial combined hyperlipidemia, sitosterolemia, dysbetalipoproteinemia, abetalipoproteinemia and hypobetalipoproteinemia.\n* Plasma HDL-C levels \\>70 mg\u002Fdl or \\\u003C25 mg\u002Fdl includes patients with deficiency of cholesteryl ester transfer protein, lecithin cholesterol acyltransferase, phospholipid transfer protein, lipoprotein lipase, hepatic lipase, or apo-CII, ANGPTL3, and Tangier disease.\n* Plasma triglyceride levels \\>150 mg\u002Fdl includes patients with deficiency of lipoprotein lipase, hepatic lipase or apoC-II, GPIHBP1, LMF1, dysbetalipoproteinemia, Type I, Type IV and Type V hyperlipidemia.","2 Years","100 Years",{"count":78,"type":21},2000,"OBSERVATIONAL","This study will evaluate people with dyslipidemias - disorders that affect the fat content in the blood. Fats, or lipids, such as cholesterol and triglycerides, are carried in the blood in particles called lipoproteins. These particles are involved in causing blood vessel diseases that can lead to conditions like atherosclerosis (hardening of the arteries) or heart attack. Participants will undergo accepted medical tests and procedures to evaluate their condition. Most of the test results are helpful in making a diagnosis and in guiding treatment.\n\nPeople with lipid disorders are eligible for this study. Representative types of patients include those with:\n\n* Plasma cholesterol levels greater than 200 mg\u002Fdl or less than 120 mg\u002Fdl\n* Plasma LDL-C levels greater than 130 mg\u002Fdl or less than 70 mg\u002Fdl\n* Plasma HDL-C levels greater than 70 mg\u002Fdl or less than 25 mg\u002Fdl\n* Unusual cholesterol deposits or xanthomas (nodules of lipid deposits on the skin)\n\nChildren under 2 years of age are excluded from the study.\n\nParticipants will undergo some or all of the following procedures:\n\n\\- Plasma evaluation. Apolipoproteins (plasma proteins involved in metabolism of cholesterol, triglycerides, phospholipids, and proteins in the blood) and enzymes involved in lipid metabolism are measured....",[27,82],"Atherosclerosis",[84,85,86,87,88,89],"Triglyceride","Phospholipids","Free and Esterfied Cholesterol","Polydisperse","Lipoprotein Transport System","Natural History","2026-06-27",{"date":59,"type":32},{"date":93,"type":32},"2003-10-14",{"name":95,"class":96},"National Heart, Lung, and Blood Institute (NHLBI)","NIH",1,{"id":99,"slug":100,"hasResults":12,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":4,"eligibilityCriteria":104,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":106,"targetDuration":4,"studyType":22,"phases":108,"briefSummary":110,"conditions":111,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":97},"100624047","phase-2-a-study-of-shr-1918-in-participants-with-hypercholesterolemia-with-inadequate-lipid-control-on-statins-plus-pcsk9-inhibitors-100624047","NCT07404553","A Study Of SHR-1918 In Participants With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors","A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II\u002FIII Study to Evaluate the Efficacy and Safety of SHR-1918 in Patients With Hypercholesterolemia With Inadequate Lipid Control on Statins Plus PCSK9 Inhibitors","Inclusion Criteria:\n\n1. Male and female ≥ 18 years old and ≤ 85 years old, who is able and willing to provide a written informed consent.\n2. TG ≤ 5.6 mmol\u002FL.\n3. LDL-C ≥ 2.6 mmol\u002FL for moderate to high ASCVD risk, LDL-C ≥ 1.8 mmol\u002FL for very high ASCVD risk, LDL-C ≥ 1.4 mmol\u002FL for ultra-high ASCVD risk.\n4. Male and female subjects of childbearing potential and their partners must have no plans to donate sperm or become pregnant during the entire study period and after the last dose, and agree to use contraceptive methods as specified in the protocol.\n\nExclusion Criteria:\n\n1. History of severe allergies\u002Fhypersensitivity reactions, or clinically significant allergies\u002Fhypersensitivity reactions as judged by the investigator, or history of allergies to drugs with similar chemical structures.\n2. Heart failure with New York Heart Association (NYHA) Class III-IV prior to screening or randomization.\n3. Acute ischemic ASCVD events within 3 months prior to screening or randomization.\n4. Have severe cardiac arrhythmia within 3 months prior to screening or randomization.\n5. Echocardiography indicates a left ventricular ejection fraction (LVEF) of less than 30% within 3 months prior to screening.\n6. History of percutaneous coronary intervention, history of coronary artery bypass grafting (CABG), history of peripheral arterial revascularisation within 1 month prior to screening or randomization.\n7. Poorly controlled type 2 diabetes mellitus or previously diagnosed type 1 diabetes mellitus; poorly controlled hypertension.\n8. Have a history of diseases that significantly affect blood lipid levels, such as nephrotic syndrome, severe liver diseases, Cushing's syndrome, or have severe arrhythmia prior to screening or randomization.\n9. Malignant tumors within 5 years.\n10. It's planned to research transcutaneous coronary intervention, coronary artery bypass grafting, carotid or peripheral artery reconstruction, pacemaker implantation, cardiac resynchronisation therapy (CRT), implantable cardioverter defibrillator (ICD) implantation and other implantations during the study.\n11. Received plasma exchange therapy within 2 months prior to screening, or plans to receive plasma exchange therapy during the study period, or has received LDL receptor gene therapy prior to screening.\n12. Have a history of major surgery within 3 months prior to screening, or plans to undergo major surgery during the study period.\n13. History of drug use, substance abuse, and alcohol abuse.\n14. Participated in or is participating in other clinical studies and has received study interventions within the past month prior to screening.\n15. Researchers determine that the subject has poor compliance or any factors that make them unsuitable for participation in this trial, including but not limited to participation in the study placing the subject at unacceptable risk or potentially interfering with the study results.","85 Years",{"count":107,"type":21},126,[53,109],"PHASE3","The purpose of the study is to evaluate the efficacy and safety of SHR-1918 in patients with hypercholesterolemia with inadequate lipid control on statins plus PCSK9 inhibitors. The efficacy and safety of SHR-1918 will be evaluated after 12-weeks and 24-weeks treatment.",[27],"2026-06-15",{"date":114,"type":32},"2026-06-16",{"date":116,"type":32},"2026-04-30",{"date":118,"type":21},"2028-08",{"name":120,"class":39},"Beijing Suncadia Pharmaceuticals Co., Ltd",{"id":122,"slug":123,"hasResults":12,"nctId":124,"briefTitle":125,"officialTitle":126,"acronym":4,"eligibilityCriteria":127,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":105,"enrollmentInfo":129,"targetDuration":4,"studyType":22,"phases":131,"briefSummary":133,"conditions":134,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":97},"100633239","moderate-intensity-statin-plus-ezetimibe-in-ckd-and-ascvd-100633239","NCT07524101","Moderate-Intensity Statin Plus Ezetimibe in CKD and ASCVD","Utilizing Lipid-lowering Therapy With Moderate-intensity Statin Plus Ezetimibe in Chronic Kidney Disease Patients With Concomitant Atherosclerotic Cardiovascular Disease: ULTRA-CKD Trial","Inclusion Criteria:\n\n1. Age 19-85 years.\n2. Chronic kidney disease stage III, IV, or V (CKD-EPI eGFR \\\u003C60 \u002F \\\u003C30 \u002F \\\u003C15 mL\u002Fmin\u002F1.73 m² or on dialysis).\n3. Established ASCVD, meeting at least one of the following:\n\n   * Prior acute coronary syndrome (myocardial infarction or unstable angina).\n   * Stable angina confirmed by imaging studies.\n   * History of coronary revascularization (percutaneous coronary intervention or coronary artery bypass grafting).\n   * Peripheral artery disease.\n   * Ischemic stroke or transient ischemic attack.\n\nExclusion Criteria:\n\n1. Baseline LDL cholesterol \\\u003C55 mg\u002FdL in the absence of statin therapy.\n2. Acute liver disease or persistently unexplained serum AST\u002FALT ≥2 × the upper limit of normal.\n3. Allergy or hypersensitivity to statins.\n4. Life expectancy \\\u003C1 year.\n5. Expected inability to complete at least 1 year of follow-up.\n6. Inability to read or understand the informed consent form.","19 Years",{"count":130,"type":21},1952,[132],"NA","The ULTRA-CKD trial is a prospective, randomized, open-label, multicenter trial designed to compare the efficacy and safety of moderate-intensity statin plus ezetimibe combination therapy versus high-intensity statin monotherapy in patients with chronic kidney disease (CKD) and concomitant atherosclerotic cardiovascular disease (ASCVD).\n\nPatients with CKD are at very high risk for ASCVD. In this population, it is important to establish a lipid-lowering strategy that optimizes cardiovascular outcomes while ensuring long-term safety. While high-intensity statins are generally considered as initial treatment option for secondary prevention, the optimal strategy for CKD patients remains to be clinicaly defined. This study aims to evaluate whether the combination of moderate-intensity statin and ezetimibe is non-inferior to high-intensity statin monotherapy in terms of 3-year composite of major adverse cardiovascular events.",[135,82,136,27,137],"Renal Insufficiency","Dyslipidemia","Cardiovascular Diseases","2026-06-11",{"date":114,"type":32},{"date":141,"type":32},"2026-05-28",{"date":143,"type":21},"2031-01-22",{"name":145,"class":146},"Yonsei University","OTHER",{"id":148,"slug":4,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":22,"phases":150,"briefSummary":25,"conditions":151,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":156,"completionDateStruct":157,"leadSponsor":158,"locationsCount":4},"100643427",{"count":20,"type":21},[24],[27],"NOT_YET_RECRUITING","2026-06-04",{"date":155,"type":32},"2026-06-08",{"date":34,"type":21},{"date":36,"type":21},{"name":38,"class":39},{"id":160,"slug":161,"hasResults":12,"nctId":162,"briefTitle":163,"officialTitle":164,"acronym":165,"eligibilityCriteria":166,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":167,"targetDuration":4,"studyType":22,"phases":169,"briefSummary":170,"conditions":171,"keywords":173,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":141,"lastUpdatePostDateStruct":179,"startDateStruct":181,"completionDateStruct":183,"leadSponsor":185,"locationsCount":97},"100637372","phase-4-dual-pcsk9-inhibition-with-inclisiran-and-alirocumab-in-secondary-prevention-100637372","NCT07581808","Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Secondary Prevention","PCSK9-DUO Trial: Dual PCSK9 Inhibition With Inclisiran and Alirocumab in Patients With High Cardiovascular Risk in Secondary Prevention","PCSK9-DUO","Inclusion Criteria:\n\n* Adults aged ≥18 years\n* Established atherosclerotic cardiovascular disease (secondary prevention), defined as prior cardiovascular events or imaging-confirmed atherosclerosis (e.g., coronary artery disease on angiography or CT, carotid plaque on ultrasound, or peripheral arterial disease).\n* Eligible for PCSK9 inhibitor therapy according to national clinical criteria\n* Fasting LDL cholesterol ≥2.5 mmol\u002FL and ≤5.0 mmol\u002FL at screening\n* Documented statin intolerance or contraindication to statin therapy\n* On stable background lipid-lowering therapy (including ezetimibe if applicable) for at least 4 weeks prior to enrollment\n* Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n* Eligibility for PCSK9 inhibitor therapy solely based on elevated lipoprotein(a) \\>1000 mg\u002FL with LDL-C below inclusion threshold\n* Prior use of any PCSK9 inhibitor (alirocumab, evolocumab or inclisiran) before enrollment\n* Planned initiation or modification of lipid-lowering therapy during the study period\n* Known homozygous familial hypercholesterolemia\n* Active liver disease or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3× upper limit of normal\n* Severe renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* Active malignancy or life expectancy \\\u003C1 year\n* Pregnancy, breastfeeding, or women of childbearing potential not using effective contraception\n* Known hypersensitivity to inclisiran, alirocumab, or any of their excipients\n* Participation in another interventional clinical trial within 30 days prior to enrollment\n* Any condition that, in the opinion of the investigator, would interfere with study participation or interpretation of results",{"count":168,"type":21},60,[24],"This study will evaluate the effectiveness and safety of combining two different types of PCSK9 inhibitors, inclisiran and alirocumab, in patients with high cardiovascular risk who are unable to tolerate statins.\n\nLowering low-density lipoprotein cholesterol (LDL-C) is essential to reduce the risk of cardiovascular events. While PCSK9 inhibitors are effective, many patients treated with a single agent do not reach recommended LDL-C targets, especially those who cannot take statins.\n\nInclisiran and alirocumab reduce LDL-C through different mechanisms. Inclisiran decreases the production of PCSK9 in the liver, while alirocumab binds circulating PCSK9 in the blood. Combining these therapies may lead to a greater reduction in LDL-C levels.\n\nIn this randomized, open-label clinical trial, approximately 60 patients in secondary prevention will be assigned to one of three groups: inclisiran alone, alirocumab alone, or a combination of both treatments. Patients will be followed for 9 months with regular clinical and laboratory assessments.\n\nThe main goal of the study is to determine whether combination therapy leads to greater LDL-C reduction compared to each treatment alone. Secondary objectives include assessing the proportion of patients achieving target LDL-C levels and evaluating treatment safety and tolerability.",[27,172],"Atherosclerotic Cardiovascular Disease (ASCVD)",[174,175,176,177,178],"Alirocumab","Inclisiran","LDL cholesterol","Secondary prevention","Statin intolerance",{"date":180,"type":32},"2026-06-02",{"date":182,"type":32},"2026-05-18",{"date":184,"type":21},"2027-06",{"name":186,"class":146},"University Medical Centre Ljubljana",{"id":188,"slug":189,"hasResults":12,"nctId":190,"briefTitle":191,"officialTitle":192,"acronym":193,"eligibilityCriteria":194,"healthyVolunteers":12,"sex":17,"minAge":195,"maxAge":196,"enrollmentInfo":197,"targetDuration":4,"studyType":22,"phases":198,"briefSummary":199,"conditions":200,"keywords":203,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":209,"lastUpdatePostDateStruct":210,"startDateStruct":212,"completionDateStruct":214,"leadSponsor":216,"locationsCount":97},"100627328","phase-2-vascular-intervention-strategies-trial-for-alzheimers-100627328","NCT07447206","Vascular Intervention Strategies Trial for Alzheimer's","Vascular Intervention Strategies Trial for Alzheimer's (VISTA)","VISTA","Inclusion Criteria:\n\n* APOE ε4 carrier (homozygote or heterozygote)\n* LDL-C of 100-250 mg\u002FdL\n* Systolic blood Pressure (SBP) 130-180 mm Hg\n* Age 50-75 years\n* Fluency in English\n* No dementia based on medical record review\n* Male or post-menopausal female\n\nExclusion Criteria:\n\n* One minute standing SBP \\\u003C 110 mm Hg\n* Arm circumference prevents from accurate BP measurement with use of available devices\n* Lost weight of \\> 10% unintendedly (within the past 6 months),\n* Contraindications to blood pressure and cholesterol lowering medications\n* Use of medications prescribed for dementia (e.g., aducanumab, donanemab, lecanemab, donepezil, galantamine, rivastigmine, memantine)\n* Evidence of dementia based on medical record review\n* Living in a skilled nursing or rehabilitation facility\n* Receiving palliative or hospice care\n* Bipolar illness or schizophrenia\n* Drug or alcohol disorder\n* Receiving chronic opioid therapy\n* Any significant neurological disease (e.g., Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis)\n* Severe loss of visual, hearing or communication ability\n* Organ transplant\n* History of stroke, symptomatic HF or left ventricular ejection fraction \\\u003C 35%\n* ESRD or eGFR \\\u003C 20 ml\u002Fmin \u002F1.73m2\n* Does not consent to be contacted or to have their medical record reviewed for research purposes\n* Concurrent participation in another clinical trial","50 Years","75 Years",{"count":40,"type":21},[53],"The proposed pharmacist-led study is a feasibility pilot trial for the management of vascular risk factors of hypertension and hypercholesterolemia in 10 APOE ε4 carriers, 50-75, at-risk for dementia. All participants will receive angiotensin receptor blockers (ARBs) for high blood pressure, and hydrophilic statins (or a non-statin alternative) for high cholesterol over a six-month period.",[201,27,202],"Hypertension","Dementia Risk Factors",[204,205,201,27,206,207,208],"APOE ε4 carriers","Dementia risk","Vascular risk factors","Pharmacist-led intervention","Feasibility study","2026-04-27",{"date":211,"type":32},"2026-05-04",{"date":213,"type":21},"2026-05",{"date":215,"type":21},"2028-06",{"name":217,"class":146},"University of Southern California",{"id":219,"slug":220,"hasResults":12,"nctId":221,"briefTitle":222,"officialTitle":223,"acronym":4,"eligibilityCriteria":224,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":225,"enrollmentInfo":226,"targetDuration":4,"studyType":22,"phases":228,"briefSummary":230,"conditions":231,"keywords":234,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":243,"lastUpdatePostDateStruct":244,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":40},"100550799","phase-1-phase-1b-study-of-verve-201-in-patients-with-refractory-hyperlipidemia-100550799","NCT06451770","Phase 1b Study of VERVE-201 in Patients With Refractory Hyperlipidemia","A Phase 1b Single Ascending Dose Study to Evaluate the Safety of VERVE-201 in Patients With Refractory Hyperlipidemia","Inclusion Criteria:\n\n* Refractory hypercholesterolemia\n* Refractory hypertriglyceridemia\n\nExclusion Criteria:\n\n* Active or history of chronic liver disease\n* Current treatment with monoclonal antibody targeting ANGPTL3 or prior treatment within specified timeframe\n* Clinically significant or abnormal laboratory values as defined by the protocol","70 Years",{"count":227,"type":21},36,[229],"PHASE1","VT-20101 is an Open-label, Phase 1b, Single-ascending dose study that will evaluate the safety of VERVE-201 administered to patients with Refractory Hyperlipidemia.\n\nVERVE-201 uses base-editing technology designed to inactivate the expression of the ANGPTL3 gene in the liver and lower circulating low-density lipoprotein cholesterol (LDL-C) and triglycerides. This study is designed to determine the safety and pharmacodynamic profile of VERVE-201 in this patient population.",[27,232,233],"Hypertriglyceridemia","Refractory Hyperlipidemia",[235,236,237,238,239,240,241,233,242],"VERVE-201","Gene Editing","Base Editing","Refractory Hypercholesterolemia","ANGPTL3","ASCVD","Refractory Hypertriglyceridemia","Familial Hypercholesterolemia","2026-04-22",{"date":245,"type":32},"2026-04-28",{"date":247,"type":32},"2024-10-30",{"date":249,"type":21},"2027-12",{"name":251,"class":39},"Verve Therapeutics, Inc.",{"id":253,"slug":254,"hasResults":12,"nctId":255,"briefTitle":256,"officialTitle":257,"acronym":4,"eligibilityCriteria":258,"healthyVolunteers":259,"sex":17,"minAge":18,"maxAge":260,"enrollmentInfo":261,"targetDuration":4,"studyType":22,"phases":263,"briefSummary":264,"conditions":265,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":266,"lastUpdatePostDateStruct":267,"startDateStruct":269,"completionDateStruct":271,"leadSponsor":273,"locationsCount":97},"100632513","assessing-the-effects-of-corn-and-avocado-oils-on-the-cardiometabolic-risk-factor-profile-100632513","NCT07514663","Assessing the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile","A Randomized, Double-Blind, Controlled Feeding, Crossover Trial to Assess the Effects of Corn and Avocado Oils on the Cardiometabolic Risk Factor Profile in Men and Women","Inclusion Criteria:\n\n1. Male or female 18 - 74 years of age, inclusive.\n2. Body mass index ≥18.5 and \\\u003C35.0 kg\u002Fm2.\n3. Fasting non-HDL-C level ≥125 mg\u002FdL and \\\u003C225 mg\u002FdL.\n4. Fasting TG level \\\u003C500 mg\u002FdL.\n5. Vein access scale score of 7-10.\n6. Judged by the Investigator to be in generally good health, based on medical history and screening measurements.\n7. Calculated energy needs of ≥1800 kcal\u002Fd per the Mifflin-St Jeor Equation, with an adjustment for energy expended in physical activity.\n8. Willing to consume only study-related foods\u002Fbeverages during each 21-d condition and visit the clinic each weekday morning during this time.\n9. If a smoker, subject has no plans to change smoking habits during the study period.\n10. Understands and is willing to complete the study procedures, including maintaining usual physical activity pattern and refraining from vigorous physical activity for 24 h prior to each clinic visit requiring a blood draw. Signs forms documenting informed consent to participate in the study and authorization for release of relevant protected health information to the study Investigator.\n\nExclusion Criteria:\n\n1. Known allergy or sensitivity to study product or any ingredients of the study product or assigned meals\u002Fsnacks\u002Fbeverages provided.\n2. Abnormal laboratory test results of clinical significance. One retest may be allowed on a case-by-case basis at the discretion of the Investigator.\n3. Fasting blood glucose ≥126 mg\u002FdL at screening or known type 1 or type 2 diabetes mellitus.\n4. Uncontrolled hypertension (systolic blood pressure ≥160 mm Hg or diastolic blood pressure ≥100 mm Hg as defined by the average blood pressure. One re-test will be allowed on a separate day prior to visit 2 (day 0) for participants whose blood pressure exceeds either of these cut points at visit 1 (day -7).\n5. Atherosclerotic cardiovascular disease, including any of the following: clinical signs of atherosclerosis including peripheral arterial disease, abdominal aortic aneurysm, carotid artery disease (symptomatic \\[e.g., myocardial infarction, angina, transient ischemic attack or stroke of carotid origin\\] or \\>50% stenosis on angiography or ultrasound) or other forms of clinical atherosclerotic disease (e.g., renal artery disease).\n6. History or presence of a clinically significant gastrointestinal, endocrine, renal, hepatic, hematologic, immunologic, dermatologic, pulmonary, pancreatic, neurologic, psychiatric, inflammatory or biliary disorder that, in the opinion of the Investigator, could interfere with the interpretation of the study results.\n7. History or presence of cancer in the prior two years, except for non-melanoma skin cancer.\n8. Unstable use (defined as initiation or change in dosage) of anti-hypertensive medication within 12 weeks of visit 1 (day -7).\n9. Use of beta-adrenergic blockers and\u002For high-dose (\\>25 mg\u002Fd) thiazide diuretics within 4 weeks of visit 1 (day -7).\n10. Unstable use (defined as initiation or change in dose) of any thyroid hormone replacement within 12 weeks of visit 1 (day -7).\n11. Unstable use (defined as initiation or change in dosage, agent, or regimen) of statin medication within 12 weeks of visit 1 (day -7).\n12. Use of any medications intended to alter the lipoprotein lipid profile, other than statins, including but not limited to, bile acid sequestrants, cholesterol absorption inhibitors, fibrates, prescription omega-3 fatty acid drugs (e.g., icosapent ethyl), or proprotein convertase subtilisin\u002Fkexin 9 (PCSK9)-targeted therapy within 12 weeks of visit 1 (day -7).\n13. Use of any foods or dietary supplement that might alter lipid metabolism, including but not limited to, omega-3 fatty acid dietary supplements (e.g., flaxseed, fish, or algal oils) or fortified foods, sterol\u002Fstanol products; red rice yeast supplements; garlic supplements; soy isoflavone supplements; and niacin or its analogues at doses \\>200 mg\u002Fd (or others at the discretion of the Investigator) within 2 weeks of visit 2 (day 0). A stable dose of any dietary fiber supplement, including Metamucil® or viscous fiber-containing supplement per day, is allowed.\n14. Use of diabetes medications, including α-glucosidase inhibitors, biguanides and biguanide combinations, dipeptidyl peptidase-4 inhibitors, glucagon-like peptide-1 receptor agonists, glucose-dependent insulinotropic polypeptide, meglitinides, sulfonylureas and sulfonylurea combinations, and thiazolidinediones, within 12 weeks of visit 1 (day -7).\n15. Use of dietary supplements that may affect carbohydrate metabolism, including chromium picolinate, ginseng, cinnamon (as a dietary supplement), and starch blockers within 2 weeks of visit 2 (day 0).\n16. Use of systemic corticosteroids within 4 weeks of visit 1 (day -7).\n17. Use of prescribed weight-loss drugs or programs within 12 weeks prior to visit 1 (day -7).\n18. Use of over-the-counter weight-loss medications, dietary supplements, or programs within 2 weeks prior to visit 2 (day 0).\n19. Weight loss or gain \\>4.5 kg in the 3 months prior to visit 1 (day -7).\n20. Extreme dietary habits (e.g., very-low-carbohydrate, vegetarian, vegan diets) in the opinion of the Investigator.\n21. History of a diagnosed eating disorder (e.g., anorexia or bulimia nervosa).\n22. Active infection or use of antibiotics within 5 d of any blood draw to measure lipoprotein lipid levels \\[Condition 1, visits 1 through 4 (days -7 through 21) and Condition 2, visits 5 through 7 (days 0 through 21)\\]. For those with an active infection and\u002For using antibiotics, participants must wait at least 5 d after the infection is resolved or antibiotic use is complete. The condition will be extended for completion of the controlled feeding period in these cases.\n23. Female who is pregnant, planning to be pregnant during the study period, lactating, or is of childbearing potential and is unwilling to commit to the use of a medically approved form of contraception throughout the study period. The method of contraception must be recorded in the source document.\n24. Positive urine drug screen for illicit drugs at visit 1.\n25. Recent history of (within 12 months of screening; visit 1, day -7) or strong potential for alcohol or substance abuse. Alcohol abuse is defined as \\>14 drinks per week (1 drink = 12 oz beer, 5 oz wine, or 1½ oz distilled spirits).\n26. Exposure to any non-registered drug product within 30 d prior to visit 1 (day -7).\n27. Any condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.",true,"74 Years",{"count":262,"type":21},54,[132],"The goal of this clinical trial is to assess the effects of corn and avocado oils as part of controlled feeding diets on the cardiometabolic risk factor profile in men and women with mild-to-moderately elevated levels of non-high-density lipoprotein cholesterol (non-HDL-C). Participants will be asked to consume the controlled feeding diet for two separate 21 day conditions, and will consume their regular diet for a 21 day washout period between the two conditions. Additionally, participants will be asked to come into the clinic on 7 different occasions, including one screening visit (visit 1, -7 days), one baseline visit (visit 2, day 0), two visits during each 21-d diet condition (visits 3 \\& 6, day 19 and visits 4 \\& 7, day 21), and a visit at the conclusion of the washout phase\u002Fstart of the second diet condition (visit 5, day 0).",[27],"2026-04-14",{"date":268,"type":32},"2026-04-17",{"date":270,"type":32},"2026-04-10",{"date":272,"type":21},"2026-09",{"name":274,"class":146},"Midwest Center for Metabolic and Cardiovascular Research",{"id":276,"slug":277,"hasResults":12,"nctId":278,"briefTitle":279,"officialTitle":280,"acronym":4,"eligibilityCriteria":281,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":196,"enrollmentInfo":283,"targetDuration":4,"studyType":22,"phases":285,"briefSummary":286,"conditions":287,"keywords":288,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":292,"lastUpdatePostDateStruct":293,"startDateStruct":295,"completionDateStruct":297,"leadSponsor":299,"locationsCount":302},"100559781","pharmacogenomic-informed-statin-prescribing-100559781","NCT06568601","Pharmacogenomic Informed Statin Prescribing","Reducing Veterans' Risk of Atherosclerotic Cardiovascular Disease Through Pharmacogenomics Informed Statin Prescribing","Inclusion Criteria:\n\nPatients will be included in the analysis if they:\n\n* Are a Veteran\n* Aged 40-75 years\n* Diabetes mellitus or cardiovascular disease (coronary, cerebral, or peripheral artery disease)\n* An upcoming primary care appointment in the next 4 months\n* No active statin prescription (any time\u002Fdose, VA, or non-VA) in the prior 6 months\n* English speaking\n* At least 1 current active VA prescription\n* At least 1 primary care appointment within the prior 2 years\n\nExclusion Criteria:\n\n* Non-Veterans\n* End-stage renal disease\n* History of rhabdomyolysis\n* Active treatment for non-dermatologic cancer\n* Known, prior SLCO1B1 genetic test results\n* Liver cirrhosis\n* Palliative care or hospice in 1-year prior to admission, during hospital stay, or at discharge\n* Active prescription for PCSK9 inhibitor\n* Inability to provide informed consent due to language impairment, cognitive disease, or other similar factors at the discretion of the research assistant or project coordinator.\n* Active enrollment in a different, interventional clinical trial, at the discretion of PI.\n* History of allogeneic stem cell transplant or liver transplant.\n* Documentation of specific adverse drug reactions thought to be attributed to statins:\n\n  * Myopathy with associated elevation in creatinine kinase \\> 10x upper limit of normal\n  * Angioedema\n  * Elevated AST\u002FALT\n  * Others at discretion of PI","40 Years",{"count":284,"type":21},410,[132],"Statins are the most cost-effective medications to lower cholesterol and cardiovascular disease (CVD) risk. However, many patients at high-risk for CVD do not accept or adhere to statins. This gap in patient's use of statins limits the full impact of these effective medications resulting in higher cholesterol levels and CVD risk. The main barriers to using statins are patients' perceived lack of benefit, excess risk of statin toxicity as well as their misperceptions of their CVD risk. Statin pharmacogenomic testing - an application of precision medicine - is a readily available, feasible, and inexpensive intervention that addresses this barrier by using genetic testing to identify the nearly 1 out of 2 patients with enhanced benefit and\u002For reduced risk of statin toxicity or increased risk for CVD. By communicating statin pharmacogenomic test results to Veterans at high-risk for CVD not taking statin therapy, the investigators aim to improve patients' perceptions of their risk of CVD and statins and, in turn, their acceptance of and adherence to statins to reduce their cholesterol levels and CVD risk.",[27],[82,289,290,291],"Hydroxymethylglutaryl-CoA Reductase Inhibitors","Pharmacogenomic Testing","Genetic Risk Score","2026-04-06",{"date":294,"type":32},"2026-04-13",{"date":296,"type":32},"2025-04-01",{"date":298,"type":21},"2028-07-28",{"name":300,"class":301},"VA Office of Research and Development","FED",2,{"id":304,"slug":305,"hasResults":12,"nctId":306,"briefTitle":307,"officialTitle":308,"acronym":309,"eligibilityCriteria":310,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":311,"targetDuration":4,"studyType":22,"phases":312,"briefSummary":313,"conditions":314,"keywords":316,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":323,"lastUpdatePostDateStruct":324,"startDateStruct":326,"completionDateStruct":328,"leadSponsor":330,"locationsCount":97},"100632020","phase-4-triple-vs-dual-lipid-lowering-therapy-for-ldl-c-reduction-in-acute-coronary-syndrome-100632020","NCT07508254","Triple vs Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome","Triple (Atorvastatin, Ezetimibe, and Bempedoic Acid) Versus Dual Lipid-Lowering Therapy for LDL-C Reduction in Acute Coronary Syndrome: A Randomized Controlled Trial","TLD-ACS","Inclusion Criteria:\n\n1. Must be older than 18 years, male or female.\n2. Diagnosis of ACS (Acute Coronary Syndrome) is confirmed when hospitalized.\n3. Eligible for high-intensity statin therapy (atorvastatin)\n4. Patients can provide written informed consent.\n5. Patients will be eager to cooperate with study drugs and follow-up visits.\n\nExclusion Criteria:\n\n1. Intolerance or hypersensitivity to study drugs.\n2. Liver or ALT\u002FAST greater than three times the upper normal.\n3. Renal dysfunction: estimated glomerular filtration rate (eGFR) less than 30 mL\u002Fmin\u002F1.73 m².\n4. Gout with frequent bouts or severe hyperuricemia.\n5. Pregnancy\u002Flactation",{"count":20,"type":21},[24],"The goal of this clinical trial is to evaluate whether triple lipid-lowering therapy (atorvastatin, ezetimibe, and bempedoic acid) is more effective than dual therapy (atorvastatin and ezetimibe) in reducing LDL cholesterol levels in adults with acute coronary syndrome. It will also assess the safety of the treatment.\n\nThe main questions it aims to answer are:\n\n* Does triple therapy result in greater reduction in LDL-C compared to dual therapy?\n* What adverse effects occur in participants receiving triple therapy?\n\nResearchers will compare triple therapy to dual therapy to determine its effectiveness in lowering LDL-C levels.\n\nParticipants will:\n\n* Receive either dual or triple lipid-lowering therapy for 3 months\n* Attend regular follow-up visits for clinical assessment and laboratory testing\n* Undergo lipid profile evaluation at baseline and at the end of the study",[315,27],"Acute Coronary Syndromes (ACS)",[317,318,319,320,321,322],"LDL-C Reduction","Statins","Ezetimibe","Bempedoic Acid","Randomized Controlled Trial","Acute Coronary Syndrome","2026-04-03",{"date":325,"type":32},"2026-04-09",{"date":327,"type":21},"2026-05-01",{"date":329,"type":21},"2026-10-31",{"name":331,"class":146},"Punjab Institute of Cardology",{"id":333,"slug":334,"hasResults":12,"nctId":335,"briefTitle":336,"officialTitle":337,"acronym":4,"eligibilityCriteria":338,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":339,"targetDuration":4,"studyType":22,"phases":341,"briefSummary":342,"conditions":343,"keywords":346,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":353,"lastUpdatePostDateStruct":354,"startDateStruct":356,"completionDateStruct":358,"leadSponsor":360,"locationsCount":4},"100629436","phase-3-a-study-of-bempedoic-acidezetimibehigh-intensity-statin-in-patients-without-cardiovascular-events-100629436","NCT07474649","A Study of Bempedoic Acid\u002FEzetimibe\u002FHigh-intensity Statin in Patients Without Cardiovascular Events","Effects of Bempedoic Acid\u002FEzetimibe\u002FHigh-intensity Statin on Plaque Regression and Stabilisation of Coronary Atherosclerosis Among Patients Without Cardiovascular Events","Inclusion Criteria:\n\nIn order to be eligible to participate in this trial, a potential participant must meet all of the following criteria:\n\n1. Age ≥18 years\n2. Having provided informed consent for participation in this trial\n3. Lipid-lowering treatment-naïve\n4. Presence of extensive coronary atherosclerosis meeting all of the criteria below:\n\n   * Unequivocal atherosclerosis in ≥5 American Heart Association (AHA) coronary segments (corresponding to a risk equivalent of obstructive coronary artery disease) and coronary artery disease - reporting and data system (CAD-RADS) category 1, 2, or 3\n   * Not expected to be a candidate for revascularisation during the duration of the trial\n   * Untreated LDL-C ≥2.6 mmol\u002FL and ≤4.5 mmol\u002FL (where a diet without pharmacological treatment is considered 'untreated')\n5. Able to provide informed consent\n\nExclusion Criteria:\n\nA potential participant who meets any of the following criteria will be excluded from participation in this trial:\n\n1. Known or suspected heterozygous or homozygous familial hypercholesterolaemia or familial combined hyperlipidaemia\n2. Known contraindication for BA, EZE, atorvastatin, and\u002For rosuvastatin. A participant with a contraindication for atorvastatin, can be assigned to triple therapy with rosuvastatin, and vice versa.\n3. Not expected to remain on a stable dose of high intensity triple therapy for the duration of the trial.\n4. History of myocardial infarction, stroke, or peripheral artery disease (PAD), and\u002For coronary revascularisation (percutaneous coronary intervention \\[PCI\\] or coronary artery bypass grafting \\[CABG\\])\n5. Significant stenosis in the left main artery (≥50%) or proximal LAD artery (≥70%), or 3-vessel coronary artery disease (≥70% stenosis in major branches), clinically indicated for revascularisation\n6. Known significant liver disease (e.g., positive hepatitis B or hepatitis C serology) or significant hepatic dysfunction (aspartate aminotransferase \\[AST\\] or alanine aminotransferase \\[ALT\\] \\>3 x upper limit of normal \\[ULN\\])\n7. Known history of gout and\u002For uric acid levels at Screening ≥6.8 mg\u002FdL\n8. Known estimated glomerular filtration rate (eGFR) \\\u003C40 mL\u002Fmin\u002F1.73m² and\u002For receiving dialysis\n9. Active malignancy (not including non-melanoma skin cancer)\n10. Pregnant or breastfeeding\n11. Body mass index (BMI) \\>35 kg\u002Fm²\n12. Anticipated life expectancy \\\u003C52 weeks at the discretion of the local investigator\n13. Requiring emergent procedures or having any evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \\\u003C90 mmHg, severe congestive heart failure (New York Heart Association \\[NYHA\\] III or IV), or acute pulmonary oedema\n14. Suspicion of acute coronary syndrome (where acute myocardial infarction and unstable angina have not been ruled out)\n15. Complex congenital heart disease\n16. Known or suspected severe valvular heart disease or valvular heart disease anticipated to require intervention within 52 weeks at the discretion of the local investigator\n17. Cardiac arrythmia or tachycardia with significant likelihood of resulting in poor PCD-CTA image quality (especially atrial fibrillation or frequent premature beats)\n18. Intracoronary stents\n19. Prior pacemaker, internal defibrillator, or abandoned lead implantation\n20. Prosthetic heart valves\n21. Contraindications to contrast media or other medications needed for proper imaging (e.g., beta blockers and nitroglycerin)\n22. Use of any experimental or investigational drug within 40 days or 5 half-lives prior to Screening (whichever is longer), or parallel participation in another interventional study",{"count":340,"type":21},103,[109],"The overall objective of the trial is to evaluate the effect of the triple therapy consisting of bempedoic acid (BA), ezetimibe (EZE), and high-intensity atorvastatin or rosuvastatin on changes in coronary plaque burden and plaque morphology in patients with coronary atherosclerosis without significant obstructive coronary artery disease and without prior history of an ischemic vascular event.",[344,345,27],"Coronary Atherosclerosis","Mixed Dyslipidemia",[347,348,349,350,319,351,352],"Coronary atherosclerosis","Primary non-familial hypercholesterolaemia","Mixed dyslipidaemia","Bempedoic acid","Atorvastatin","Rosuvastatin","2026-03-16",{"date":355,"type":32},"2026-03-19",{"date":357,"type":21},"2026-06-01",{"date":359,"type":21},"2028-10-02",{"name":361,"class":39},"Daiichi Sankyo",{"id":363,"slug":364,"hasResults":12,"nctId":365,"briefTitle":366,"officialTitle":367,"acronym":368,"eligibilityCriteria":369,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":105,"enrollmentInfo":370,"targetDuration":4,"studyType":22,"phases":372,"briefSummary":373,"conditions":374,"keywords":4,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":378,"lastUpdatePostDateStruct":379,"startDateStruct":381,"completionDateStruct":383,"leadSponsor":385,"locationsCount":97},"100622345","electronic-letters-to-improve-patient-activation-in-ihd-the-nudge-ihd-trial-100622345","NCT07382414","Electronic Letters to Improve Patient Activation in IHD: The NUDGE-IHD Trial","NUDGE-IHD: A Nationwide Pragmatic Randomized Trial of Electronic Nudges to Increase Patient Activation to Support Risk-factor Control in Ischemic Heart Disease","NUDGE-IHD","Inclusion criteria\n\n* Alive on identification date\n* Diagnosis of IHD defined as either an A or B diagnosis code of I20-I25 in the Danish National Patient Register first registered \\> 6 months prior to identification date\n* Latest available LDL-C is over 1.4 mmol\u002Fl measured up to 3 years prior to the identification date, defined using NPU codes NPU01568, NPU10171 or DNK35308 from the Danish National Laboratory Register\n* Age \\>= 18 years and \\\u003C= 85 on identification date\n\nExclusion criteria\n\n* Nursing home residents\n* Exemption from and thus not access to Digital Post",{"count":371,"type":21},100000,[132],"The goal of this clinical trial is to learn whether simple electronic information letters can increase patient activation and improve risk-factor monitoring in adults in Denmark with ischemic heart disease (IHD) who have LDL cholesterol above the recommended treatment target. A subgroup of participants with elevated lipoprotein(a) \\[Lp(a)\\] will also be randomized to receive an additional information letter.\n\nThe main questions the study aims to answer are:\n\n* Does sending an electronic letter about elevated LDL cholesterol increase the proportion of patients who have at least one LDL-cholesterol test within 6 months?\n* Among patients with ischemic heart disease and elevated Lp(a), does receiving an information letter about Lp(a) increase patient activation, reflected by cardiometabolic risk-factor monitoring?\n\nBecause this is a randomized trial, researchers will compare people who receive the electronic letter(s) with people who do not receive any letter to determine whether the letters encourage patients to take action, such as obtaining laboratory tests or contacting their doctor.\n\nParticipants will:\n\n* Receive an electronic letter through Denmark's national digital mailbox system (Digital Post) or receive no letter, depending on random assignment.\n* Continue their usual health care, with no additional visits, treatments, or procedures required for the study.\n* Have all study information collected from existing Danish nationwide health registries.",[375,27,376,377],"Coronary Artery Disease","Lipoprotein(a)","Secondary Prevention","2026-03-08",{"date":380,"type":32},"2026-03-10",{"date":382,"type":21},"2026-04",{"date":384,"type":21},"2026-10",{"name":386,"class":146},"Tor Biering-Sørensen",{"id":388,"slug":389,"hasResults":12,"nctId":390,"briefTitle":391,"officialTitle":392,"acronym":393,"eligibilityCriteria":394,"healthyVolunteers":12,"sex":17,"minAge":282,"maxAge":196,"enrollmentInfo":395,"targetDuration":4,"studyType":22,"phases":397,"briefSummary":398,"conditions":399,"keywords":401,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":405,"lastUpdatePostDateStruct":406,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":97},"100553593","phase-2-emergency-medicine-cardiovascular-risk-assessment-for-lipid-disorders-trial-100553593","NCT06488105","Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders Trial","Initiating Preventive Care for Hyperlipidemia in the Emergency Department: The EMERALD (Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders) Trial","EMERALD RCT","Inclusion Criteria\n\n1. Evaluation for Acute Coronary Syndrome\n2. Age 40-75 Years\n3. 10-year Atherosclerotic Cardiovascular Disease (ASCVD) Risk ≥7.5% or Known Diabetes or\n\nKnown ASCVD:\n\n1. Myocardial Infarction\n2. Unstable Angina\n3. Percutaneous Coronary Intervention\n4. Coronary Artery Bypass Graft\n5. Stroke\n6. Transient Ischemic Attack\n7. Peripheral Artery Disease\n\nExclusion Criteria\n\n1. ST-Segment Elevation Myocardial Infarction (STEMI) Activation\n2. ST Depression \\>1 mm in Contiguous Leads\n3. On a Lipid Lowering Agent (Statin, PCSK9 Inhibitor, Bempedoic Acid, Ezetimibe, Inclisiran, etc.)\n4. Inability to Return for 30-day Follow-up\n5. Unstable Vitals (Systolic blood pressure \\\u003C90, HR \\>120 or \\\u003C50, oxygen saturation \\\u003C90%)\n6. Statin Intolerance\n7. Any Resulted High-Sensitivity Troponin I ≥100 ng\u002FL\n8. End-stage renal disease (ESRD) and\u002For glomerular filtration rate (GFR) \\\u003C30 mL\u002Fmin\u002F1.73 m2\n9. Liver Cirrhosis\n10. Pregnancy\n11. Anticipated Hospitalization\n12. Life Expectancy \\\u003C1 Year\n13. Transfer from Another Hospital\n14. Prisoner\n15. Non-English Speaking",{"count":396,"type":21},130,[53],"Emergency Medicine Cardiovascular Risk Assessment for Lipid Disorders (EMERALD) is a protocolized intervention based on American College of Cardiology\u002FAmerican Heart Association and US Preventive Services Task Force guidelines designed to initiate preventive cardiovascular care for emergency department patients being evaluated for acute coronary syndrome. The overarching goals of this proposal are to (1) determine the efficacy of EMERALD at lowering low-density lipoprotein cholesterol (LDL-C) and non high-density lipoprotein cholesterol (non-HDL-C) among at-risk Emergency Department (ED) patients who are not already receiving guideline-directed outpatient preventive care and (2) inform our understanding of patient adherence and determinants of implementation for ED-based cardiovascular disease prevention strategies.",[400,27,137,82],"Lipid Disorder",[402,403,404],"hyperlipidemia","cardiovascular disease","atherosclerotic cardiovascular disease","2026-02-26",{"date":407,"type":32},"2026-02-27",{"date":409,"type":32},"2024-08-05",{"date":411,"type":21},"2029-03-31",{"name":413,"class":146},"Wake Forest University Health Sciences",{"id":415,"slug":416,"hasResults":12,"nctId":417,"briefTitle":418,"officialTitle":418,"acronym":419,"eligibilityCriteria":420,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":421,"targetDuration":423,"studyType":79,"phases":4,"briefSummary":424,"conditions":425,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":427,"startDateStruct":429,"completionDateStruct":431,"leadSponsor":433,"locationsCount":97},"100621764","multicenter-study-on-the-evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-bempedoic-acid-in-italy-100621764","NCT07374861","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Bempedoic Acid in Italy","BEMPENET","Inclusion Criteria:\n\n* Patients under Bempedoic acid treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years\n* Patients who refuse to participate and to sign informed consent",{"count":422,"type":21},1500,"3 Years","Evaluation of adherence, persistence, and efficacy of treatment with Bempedoic acid in a real-life Italian population.",[27],"2026-01-21",{"date":428,"type":32},"2026-01-29",{"date":430,"type":32},"2025-11-04",{"date":432,"type":21},"2028-12-31",{"name":434,"class":146},"Federico II University",{"id":436,"slug":437,"hasResults":12,"nctId":438,"briefTitle":439,"officialTitle":440,"acronym":441,"eligibilityCriteria":442,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":443,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":445,"conditions":446,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":447,"startDateStruct":449,"completionDateStruct":451,"leadSponsor":453,"locationsCount":97},"100538157","multicenter-study-on-the-evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-inclisiran-in-italy-100538157","NCT06287177","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With Inclisiran in Italy - CHOLINET (CHOLesterol Italian Inclisiran NETwork)","CHOLINET","Inclusion Criteria:\n\n* Patients under Inclisiran treatment\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years\n* Patients who refuse to participate and to sign informed consent",{"count":444,"type":21},3000,"Evaluation of adherence, persistence and efficacy of treatment with Inclisiran in a real-life Italian population",[27],{"date":448,"type":32},"2026-01-22",{"date":450,"type":32},"2022-11-01",{"date":452,"type":21},"2030-11-01",{"name":434,"class":146},{"id":455,"slug":456,"hasResults":12,"nctId":457,"briefTitle":458,"officialTitle":459,"acronym":460,"eligibilityCriteria":461,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":49,"enrollmentInfo":462,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":426,"lastUpdatePostDateStruct":466,"startDateStruct":467,"completionDateStruct":469,"leadSponsor":471,"locationsCount":472},"100472357","evaluation-of-adherence-persistence-and-efficacy-of-treatment-with-pcsk9-inhibitors-in-italy-100472357","NCT05430828","Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy","Multicenter Study on the Evaluation of Adherence, Persistence and Efficacy of Treatment With PCSK9 Inhibitors in Italy","AT-TARGET-IT","Inclusion Criteria:\n\n* Patients under PCSK9 inhibitor treatment.\n\nExclusion Criteria:\n\n* Age \\\u003C 18 years o \\> 80 years;\n* Patients who refuse to participate and to sign informed consent.",{"count":463,"type":21},5000,"Evaluation of adherence, persistence and efficacy of treatment with PCSK9 inhibitors in a real-life Italian population.",[27],{"date":448,"type":32},{"date":468,"type":32},"2020-03-07",{"date":470,"type":21},"2030-03-31",{"name":434,"class":146},27,{"id":474,"slug":475,"hasResults":12,"nctId":476,"briefTitle":477,"officialTitle":477,"acronym":4,"eligibilityCriteria":478,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":479,"targetDuration":4,"studyType":22,"phases":481,"briefSummary":482,"conditions":483,"keywords":488,"overallStatus":152,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100614424","activate-tennessee-a-chw-supported-program-for-patient-activation-100614424","NCT07279415","Activate Tennessee: A CHW-Supported Program for Patient Activation","Inclusion criteria:\n\n* 18 years and older,\n* Able to speak and understand English\n* Have been told by a health care provider that they have two or more, chronic health conditions\n* Are classified as medically underserved or socially vulnerable person",{"count":480,"type":21},300,[132],"The research project will involve community health workers (CHWs) that will help participants to better understand their medical conditions and to responsibly manage their medical needs. The project will focus on participants with the greatest medical needs and those that have many different illnesses at the same time. CHWs will help guide participants in focusing on improving their knowledge and confidence to manage their health conditions and to improve their ability to understand how the healthcare system works. This will give participants the opportunity to take charge of their illnesses and possibly improve their health conditions over time. The CHWs will work together with participants to develop a health plan focused on their specific health needs.",[484,201,485,486,487,27],"Diabetes","Cardio Vascular Disease","Infectious Diseases Morbidity","Chronic Kidney Disease",[489],"community health worker, co-morbidities","2025-12-09",{"date":492,"type":32},"2025-12-12",{"date":494,"type":21},"2025-12-20",{"date":496,"type":21},"2027-09",{"name":498,"class":146},"Meharry Medical College",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":504,"acronym":4,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":17,"minAge":506,"maxAge":225,"enrollmentInfo":507,"targetDuration":4,"studyType":22,"phases":509,"briefSummary":510,"conditions":511,"keywords":512,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":514,"lastUpdatePostDateStruct":515,"startDateStruct":517,"completionDateStruct":519,"leadSponsor":521,"locationsCount":97},"100615647","effect-of-two-food-supplements-on-lipid-profile-in-patients-with-mild-hypercholesterolemia-100615647","NCT07295327","Effect of Two Food Supplements on Lipid Profile in Patients With Mild Hypercholesterolemia","Randomized and Comparative Clinical Study on the Lipid-lowering Efficacy and Tolerability of Two Food Supplements in Mild Hypercholesterolemia","Inclusion Criteria:\n\n* age between 35-70 years\n* both genders\n* LDL-C levels between 115 and 190 mg\u002Fdl\n* subjects able to understand the informed consent and sign it before enrollment in the study\n\nExclusion Criteria:\n\n* personal history of cardiovascular disease or equivalent risk factors\n* Tg levels ≥ 400 mg\u002Fdl\n* obesity \\[body mass index (BMI) ≥ 30 kg\u002Fm²\\]\n* taking hypolipidemic drugs or supplements that affect lipid metabolism\n* diabetes mellitus\n* known thyroid, liver, kidney or muscle diseases\n* any medical or surgical condition that makes patient compliance with the study protocol complex or inconsistent\n* any known allergy or hypersensitivity to one or more components of the food supplements","35 Years",{"count":508,"type":21},40,[132],"The primary outcome is to evaluate the effect of Cynacol on the change in LDL-C levels compared to Metacol after 90 days of supplementation.\n\nThe secondary outcomes are to evaluate:\n\n\\- the change of TC, non-HDL cholesterol (non-HDL-C), apolipoprotein B (apoB), Tg, HDL-C levels after 90 days of supplementation with Cynacol compared to Metacol. The safety outcome is collection of the adverse events not related, related or possibly related to the study products.",[27],[27,513],"Food supplement","2025-12-08",{"date":516,"type":32},"2025-12-19",{"date":518,"type":32},"2025-09-30",{"date":520,"type":21},"2026-03-31",{"name":522,"class":146},"Fondazione IRCCS Policlinico San Matteo di Pavia",{"id":524,"slug":525,"hasResults":12,"nctId":526,"briefTitle":527,"officialTitle":528,"acronym":529,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":531,"targetDuration":4,"studyType":22,"phases":533,"briefSummary":534,"conditions":535,"keywords":537,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":540,"lastUpdatePostDateStruct":541,"startDateStruct":543,"completionDateStruct":545,"leadSponsor":547,"locationsCount":97},"100515235","effects-of-a-digital-health-application-lipodia-on-ldl-cholesterol-levels-100515235","NCT05988866","Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels","Effects of a Digital Health Application (Lipodia) on LDL-cholesterol Levels in Individuals With LDL-cholesterol Levels Above Recommended Targets for Reducing Cardiovascular Risk: Randomized Controlled Trial","DIGICHOL","Inclusion criteria\n\n* Age ≥ 18\n* Diagnosis of hypercholesterolemia (ICD-10 E78.0, E78.2, E78.4, E78.5, E78.8, E78.9) confirmed by a laboratory test and physician diagnosis\n* LDL-C levels above risk-adapted target\n* TG levels \\\u003C 400 mg\u002FdL\n* Stability of potential drug treatment during the last 4 weeks\n* Stability of potential hormonal treatment during the last 6 months\n* Patient was made aware of lifestyle measures by GP or specialist\n* Consent to participation\n* Sufficient knowledge of the German language\n\nExclusion criteria\n\n* Homozygous Familial Hypercholesterolemia (FH), given that it is a genetic condition which is relatively unresponsive to lifestyle changes\n* Hyperlipidemia type III, given that it is a genetic condition which is relatively unresponsive to lifestyle changes\n* Patients receiving plasmapheresis\n* Lp(a) \\> 50 mg\u002FdL\n* current pregnancy or planned pregnancy during the study period\n* planned major operations\n* liver dysfunction\n* end-stage renal failure\n* other systemic conditions that might interfere with successful study participation\n* Plans to change drug (including hormonal) treatment in the upcoming 6 months\n* Use of another digital intervention for hypercholesterolemia\u002Fdyslipidemia in the past",{"count":532,"type":21},272,[132],"The goal of this clinical trial is to find out if lipodia, a digital health intervention, can help lower cholesterol levels and improve other health measures in adults with high cholesterol.\n\nThe main questions it aims to answer are:\n\n* Does lipodia, together with regular treatment, lower LDL cholesterol (bad cholesterol) better than regular treatment alone?\n* Does lipodia help improve other health outcomes, like how confident participants feel in managing their health?\n\nResearchers will compare two groups:\n\n* Intervention group: Participants use the lipodia intervention and continue their usual treatment.\n* Control group: Participants continue with their usual treatment only.\n\nParticipants will:\n\n* Fill out questionnaires online and visit a certified lab at the start of the study, after 3 months, and after 6 months\n* Have blood tests at each lab visit to check their cholesterol and other blood fat levels\n* Continue with their usual treatment (both groups) and use lipodia, a digital health app, for six months (intervention group only)",[27,536],"Dyslipidemias",[538,539],"LDL-C","digital intervention","2025-08-18",{"date":542,"type":32},"2025-08-22",{"date":544,"type":32},"2025-02-03",{"date":546,"type":21},"2026-01",{"name":548,"class":39},"Gaia AG",{"id":550,"slug":551,"hasResults":12,"nctId":552,"briefTitle":553,"officialTitle":554,"acronym":555,"eligibilityCriteria":556,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":557,"targetDuration":4,"studyType":22,"phases":558,"briefSummary":559,"conditions":560,"keywords":561,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":564,"lastUpdatePostDateStruct":565,"startDateStruct":567,"completionDateStruct":569,"leadSponsor":571,"locationsCount":573},"100464233","guideline-oriented-approach-to-lipid-lowering-in-asia-pacific-100464233","NCT05325034","Guideline Oriented Approach To Lipid Lowering In Asia-Pacific","Guideline Oriented Approach To Lipid Lowering In Asia-Pacific (GOAL-ASIA)","GOAL-ASIA","Inclusion Criteria:\n\n* 18 years of age\n* Admission for Type I myocardial infarction\n\nExclusion Criteria:\n\n* LDL \\\u003C1.4mmol\u002FL at baseline\n* Unable to provide contact details of primary care physician\u002Fgeneral practitioner\n* Unable to provide written informed consent.\n* Unlikely to survive \\>12 months",{"count":78,"type":21},[132],"Multinational, patient-level randomised, multi-phase standard-of-care control arm, parallel group, implementation study.\n\nPatients will be recruited during hospitalisation and be randomised to a multifaceted intervention to be delivered either 'early' (baseline) or 'late' (6 months), in a 1:1 fashion.",[137,322,82,27],[322,562,563],"Lipid management","Cholesterol","2025-08-11",{"date":566,"type":32},"2025-08-14",{"date":568,"type":32},"2022-09-15",{"date":570,"type":21},"2026-12",{"name":572,"class":146},"Stephen Nicholls",22,{"id":575,"slug":576,"hasResults":12,"nctId":577,"briefTitle":578,"officialTitle":579,"acronym":580,"eligibilityCriteria":581,"healthyVolunteers":12,"sex":17,"minAge":128,"maxAge":4,"enrollmentInfo":582,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":584,"conditions":585,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":586,"lastUpdatePostDateStruct":587,"startDateStruct":589,"completionDateStruct":591,"leadSponsor":593,"locationsCount":97},"100599339","a-study-to-evaluate-the-effectiveness-and-safety-of-fixed-dose-combination-of-pitavastatin-ezetimibe-100599339","NCT07083206","A Study to Evaluate the Effectiveness and Safety of Fixed-Dose Combination of Pitavastatin\u002F Ezetimibe","A Multi-center, Prospective, Non-intervention, Observational Study to Evaluate the Effectiveness and Safety of Switching to Pevarozet Tablet in Patients With Hypercholesterolemia Previously Treated With Atorvastatin or Rosuvastatin Monotherapy","PIVOTAL","Inclusion Criteria:\n\n* Adults aged 19 years or older\n* Patients diagnosed with hypercholesterolemia who have been stably treated with atorvastatin or rosuvastatin monotherapy for at least 3 months, and for whom switching to fixed-dose combination pitavastatin\u002Fezetimibe has been clinically decided\n* Patients with available clinical laboratory test results related to efficacy and safety (TC, TG, HDL-C, LDL-C, AST, ALT, Cr\u002FeGFR) within 12 months prior to switching to fixed-dose combination pitavastatin\u002Fezetimibe (no changes in statin regimen or dosage during that period)\n* Individuals (or their legally authorized representatives) who voluntarily provide written informed consent to participate in the study\n\nExclusion Criteria:\n\n* Known hypersensitivity or history of hypersensitivity to any component of the investigational product\n* Patients with active liver disease or persistent, unexplained elevations of aminotransferase levels\n* Patients with severe hepatic impairment, biliary obstruction, or cholestasis\n* Patients currently receiving cyclosporine treatment\n* Patients diagnosed with myopathy\n* Pregnant or breastfeeding women, or women who may be pregnant\n* Patients with genetic disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption\n* Any patient who, in the opinion of the investigator, is deemed unsuitable for study participation",{"count":583,"type":21},4500,"The objective of this study is to evaluate the effectiveness and safety of Pitavastatin\u002FEzetimibe FDC in patients with hypercholesterolemia.",[27,536],"2025-08-03",{"date":588,"type":32},"2025-08-07",{"date":590,"type":32},"2025-07-29",{"date":592,"type":21},"2029-01",{"name":594,"class":39},"Ahn-Gook Pharmaceuticals Co.,Ltd",{"id":596,"slug":597,"hasResults":12,"nctId":598,"briefTitle":599,"officialTitle":600,"acronym":4,"eligibilityCriteria":601,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":602,"targetDuration":4,"studyType":79,"phases":4,"briefSummary":604,"conditions":605,"keywords":606,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":609,"lastUpdatePostDateStruct":610,"startDateStruct":612,"completionDateStruct":614,"leadSponsor":616,"locationsCount":97},"100582105","pmmhri-pitavastatin-registry-100582105","NCT06858982","PMMHRI-Pitavastatin Registry","The Polish Mother's Memorial Hospital Research Institute Pitavastatin Registry","Inclusion Criteria:\n\n* patient takling pitavastatin based on the 2021 Polish Lipid Guidelines\n\nExclusion Criteria:\n\n\\-",{"count":603,"type":21},500,"The PMMHRI-Pitavastatin Registry is a non-interventional, single-center registry conducted at the Polish Mother's Memorial Hospital Research Institute (PMMHRI). Established in January 2024, the registry enrolls all patients from the Department of Cardiology and Adult Congenital Heart Diseases, the Department of Endocrinology, as well as outpatient cardiology and endocrinology clinics who are prescribed pitavastatin.",[27],[607,608],"hypercholesterolemia","pitavastatin","2025-02-27",{"date":611,"type":32},"2025-03-05",{"date":613,"type":32},"2024-06-01",{"date":615,"type":21},"2028-12",{"name":617,"class":146},"Polish Mother Memorial Hospital Research Institute",{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":12,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":625,"targetDuration":4,"studyType":22,"phases":627,"briefSummary":628,"conditions":629,"keywords":634,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":637,"lastUpdatePostDateStruct":638,"startDateStruct":640,"completionDateStruct":642,"leadSponsor":643,"locationsCount":645},"100559771","phase-3-a-study-on-efficacy-and-safety-of-hst101-in-chinese-patients-with-hypercholesterolemia-100559771","NCT06568471","A Study on Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","A Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of HST101 in Chinese Patients with Hypercholesterolemia","Inclusion Criteria:\n\n* Provision of written and signed informed consent form prior to any study-specific procedure;\n* Male or female participants ≥18 years of age at the screening visit;\n* Body weight ≥ 40 kg and body mass index (BMI) ≥18 and ≤35 kg\u002Fm2;\n* On a stable diet and lipid-lowering oral drugs (such as statins, ezetimibe or Hybutimibe, omega-3 compounds, fenofibrate, nicotinic acid, etc.) for at least 4 weeks prior to the first drug administration\n* LDL-C≥1.8 mmol\u002FL (70 mg\u002FdL) and TG≤4.52 mmol\u002FL (400 mg\u002FdL) at screening for ASCVD patients or those at very (ultra)-high risk for ASCVD, including patients with HeFH; LDL-C ≥ 2.6 mmol\u002FL (100 mg\u002FdL) and TG ≤ 4.52 mmol\u002FL (400 mg\u002FdL) at screening for patients at high-risk for ASCVD including patients with HeFH;\n* Patients on a PCSK9 mAb at a dose of 75 mg, 140 mg, or 150 mg Q2W must undergo a washout period of ≥6 weeks after the last dose; for those on 300 mg or 420 mg Q4W, the washout period is ≥10 weeks following last dose;\n* Female of childbearing potential must have a negative pregnancy test at the last screening visit and consent to use highly effective contraceptives during the trial and 3 months after the last dose of investigational drug.\n\nExclusion Criteria:\n\n* Documented history of homozygous familial hypercholesterolemia (HoFH);\n* Estimated glomerular filtration rate (eGFR)\\\u003C30 mL\u002Fmin\u002F1.73m2;\n* Active liver disease or hepatic dysfunction, history of liver transplant, and\u002For ALT or AST \\>2.5 × ULN at screening;\n* Poorly controlled thyroid disorder including hypothyroidism or hyperthyroidism;\n* Poorly controlled Type 1 or Type 2 diabetes mellitus defined as fasting blood glucose ≥11.0 mmol\u002FL (200 mg\u002FdL) and glycosylated hemoglobin (HbA1c) ≥ 9%;\n* Serious arrhythmia, MI, unstable angina pectoris, PCI, CABG, implantable cardioverter defibrillator, aortic valve surgery or stroke within 3 months prior to the first dose;\n* Planned cardiac surgery or revascularization during the study period;\n* New York Heart Association (NYHA) Class III-IV heart failure;\n* Pregnant or lactating women;\n* Poorly controlled hypertension (SBP≥160 mmHg or DBP≥100 mmHg in a sitting position)\n* Unexplained creatine kinase (CK) \\> 5 x ULN (retested once is needed if suspected to be related to excessive exercise or abnormal activity);\n* LDL apheresis or plasma exchange within 2 months prior to the first dose;\n* HIV, Treponema pallidum, or HCV antibody test positive, or HBV-DNA \\>ULN at screening;\n* History of prescription drug abuse, illicit drug use or alcohol abuse within 6 months prior to screening;\n* History of any major drug allergy, including allergy to protein biologics;\n* Participate another clinical trial within 30 days or less than 5 half-lifes (drug) before screening, whichever is longer",{"count":626,"type":21},210,[109],"This randomized study is to assess LDL-C reductions at Week 12 with monthly (Q4W \\[≤31 days\\]) dosing of HST101 (lerodalcibep) 300 mg administered subcutaneously (SC) compared to placebo in patients with atherosclerotic cardiovascular disease (ASCVD) or very-high\u002Fhigh risk for ASCVD including Heterozygous familial hypercholesterolemia (HeFH) on a stable diet and oral LDL-C lowering drug therapy, followed by 36-week open-label treatment with subsequent 4-week follow-up for total 52-week long-term safety and efficacy evaluation.",[27,536,630,631,632,633,240],"Primary Hypercholesterolemia","Heterozygous Familial Hypercholesterolemia","Hyperlipidemia; Mixed","Metabolic Disease",[635,636,538],"PCSK9 inhibitor","Lerodalcibep","2025-02-04",{"date":639,"type":32},"2025-02-06",{"date":641,"type":32},"2024-11-16",{"date":213,"type":21},{"name":644,"class":39},"Hasten Biopharmaceutical Co., Ltd.",18]