[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"statin\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:statin":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,5,0,[8,42,73,102,130],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100575091","phase-4-comparison-of-pitavastatin-plus-ezetimibe-versus-high-intensity-statin-therapy-on-risk-of-new-onset-diabetes-mellitus-100575091",false,"NCT06767774","Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus","Comparison of Pitavastatin Plus Ezetimibe Versus High-Intensity Statin Therapy on Risk of New-Onset Diabetes Mellitus in Prediabetic Patients With Atherosclerotic Cardiovascular Disease","Inclusion Criteria:\n\n* Age Requirement:\n\n  * Patients aged 18 years or older.\n\nGlycemic Status:\n\n* Patients who are not taking oral hypoglycemic agents (OHAs) and meet all of the following criteria:\n\n  * Fasting glucose less than 126 mg\u002FdL.\\*\n  * HbA1c less than 6.5%.\n  * Plasma glucose less than 200 mg\u002FdL after 2 hours during a 75 g oral glucose tolerance test (OGTT).\\*Note: For fasting glucose, two measurements of 126 mg\u002FdL or greater within 3 months are required for a diagnosis of diabetes.\n\nCardiovascular Disease:\n\n* Patients with established atherosclerotic cardiovascular disease, defined as having at least one of the following:\n\n  * Coronary Heart Disease (CHD):\n\n    * Documented history of myocardial infarction (MI).\n    * History of coronary revascularization.\n\n      * 50% stenosis of a major epicardial coronary artery confirmed by cardiac catheterization, computed tomography (CT), or coronary angiography.\n  * Cerebrovascular Disease:\n\n    \\>History of stroke of atherosclerotic origin.\n    * History of carotid revascularization.\n\n      \\>≥50% stenosis of the carotid artery confirmed by X-ray angiography, magnetic resonance (MR) angiography, CT angiography, or Doppler ultrasound.\n  * Symptomatic Peripheral Arterial Disease (PAD):\n\n    \\>Intermittent claudication with an ankle-brachial index (ABI) of 0.90 at rest.\n    * Intermittent claudication with ≥50% stenosis of a peripheral artery (excluding the carotid artery) confirmed by X-ray angiography, MR angiography, CT angiography, or Doppler ultrasound.\n    * History of revascularization of peripheral arteries (excluding carotid arteries).\n    * Lower extremity amputation at or above the ankle due to atherosclerotic disease (excluding trauma or osteomyelitis).\n\nDietary Requirements:\n\n* Patients must be on a stable diet prior to randomization and able to adhere to the National Cholesterol Education Program (NCEP) Therapeutic Lifestyle Change (TLC) diet or an equivalent throughout the study.\n\nInformed Consent:\n\n* Subjects or their legal representatives must provide written informed consent to the study protocol and clinical follow-up schedule.\n* An informed consent form approved by the institutional review board (IRB)\u002Fethics committee of the study site must be signed.\n\nExclusion Criteria:\n\n* Patient is pregnant or breastfeeding or of childbearing potential.\n* Requires concomitant administration of strong inhibitors of CYP3A4 (itraconazole, ketoconazole, protease inhibitors, erythromycin, clarithromycin, telithromycin, and nefazodone) or CYP2C9 (relative contraindication not dependent on CYP450 statins).\n* Chronic kidney disease (eGFR \\\u003C 30 ml\u002Fmin\u002F1.73m²) or dialysis-dependent renal failure.\n* Uncontrolled hypothyroidism.\n* Personal or family history of an inherited muscle disorder.\n* History of statin-induced muscle toxicity.\n* Alcohol-dependent person.\n* Hypersensitivity to statins and ezetimibe.\n* Hemodynamic instability at the time of enrollment: cardiogenic shock, refractory ventricular arrhythmia, or congestive heart failure (New York Heart Association class IV) at randomization.\n* History of hemorrhagic stroke or intracranial hemorrhage, TIA, or ischemic stroke within the past 6 months.\n* Planned surgery requiring discontinuation of statins or ezetimibe within 6 months of randomization.\n* Current treatment for active cancer.\n* Clinically significant abnormal findings identified at the screening visit, physical examination, laboratory tests, or electrocardiogram that, in the investigator's judgment, may interfere with safe completion of the study.\n* Liver disease or biliary obstruction, elevated liver enzymes (ALT or AST \\> the upper limit of normal) or elevated total bilirubin (total bilirubin \\> 2 times the upper limit of normal) at screening.\n* Life expectancy for noncardiac or cardiac causes \\\u003C 1 year.\n* Unwillingness or inability to comply with the procedures described in this protocol.\n* Previously diagnosed with diabetes mellitus and compliant with lifestyle modification and taking oral hypoglycemic agents (OHAs) or insulin.","ALL","18 Years",{"count":19,"type":20},2000,"ESTIMATED","INTERVENTIONAL",[23],"PHASE4","The AVOID-DM trial is a multicenter, prospective, randomized study comparing the risk of new-onset diabetes mellitus (DM) between two cholesterol-lowering strategies in patients with prediabetes and established atherosclerotic cardiovascular disease (ASCVD). The study evaluates pitavastatin plus ezetimibe combination therapy versus high-intensity statin monotherapy (rosuvastatin 20 mg). Enrolling 2,000 non-diabetic participants with ASCVD, subjects are randomized 1:1 into the two treatment arms. The primary outcome is the incidence of new-onset DM over a follow-up period of up to 36 months. Secondary outcomes include cardiovascular events, changes in LDL cholesterol, fasting glucose, HbA1c, and insulin resistance. This trial hypothesizes that the combination therapy will achieve LDL targets with a lower risk of new-onset DM compared to high-intensity statin monotherapy.",[26,27,28],"ASCVD","Diabetes","Statin","RECRUITING","2025-04-24",{"date":32,"type":33},"2025-04-27","ACTUAL",{"date":35,"type":33},"2025-04-25",{"date":37,"type":20},"2030-01-31",{"name":39,"class":40},"Korea University Anam Hospital","OTHER",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":52,"phases":4,"briefSummary":53,"conditions":54,"keywords":58,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":41},"100562511","efficacy-of-probucol-combined-with-statins-treatment-for-ischemic-stroke-100562511","NCT06604117","Efficacy of Probucol Combined with Statins Treatment for Ischemic Stroke","A Prospective, Open-label Study Evaluating the Effects of Probucol Combined with Statins on Atherosclerotic Characteristics and Prognosis in Patients with Ischemic Stroke","EPCIS","Inclusion Criteria:\n\n1. Aged 18 years or older.\n2. Diagnosed with ischemic stroke (IS) confirmed by cranial CT\u002FMRI.\n3. Onset of stroke within the last 30 days.\n4. Evidence of atherosclerosis (AS) in at least one artery (carotid, coronary, aorta, renal, or peripheral arteries) identified through neck CTA, coronary CTA, or ultrasound examination of lower extremity arteries.\n5. Signed informed consent.\n\nExclusion Criteria:\n\n1. History of allergy to Probucol or statins.\n2. Non-atherosclerotic arterial stenosis, such as vasculitis, moyamoya disease, or arterial dissection.\n3. Potential cardiac embolic sources, such as atrial fibrillation, artificial heart valves, endocarditis, or patent foramen ovale.\n4. Known bleeding tendencies or hemorrhagic diseases, such as thrombocytopenia (platelet count \\&lt; 100 × 10\\^9\u002FL), hemorrhagic stroke, or gastrointestinal bleeding.\n5. Severe myocardial diseases such as myocardial infarction (MI) or myocarditis.\n6. Liver (ALT or AST \\&gt; twice the upper limit of normal) or kidney (creatinine \\&gt; 1.5 times the upper limit of normal or glomerular filtration rate \\&lt; 50 ml\u002Fmin) dysfunction.\n7. Ventricular tachycardia, bradycardia, torsades de pointes, or syncopal episodes of cardiac origin.\n8. Prolonged QT interval or conditions that may prolong the QT interval, such as certain medications.\n9. Suffering from a severe illness with a life expectancy of less than one year or unable to cooperate due to cognitive or psychological issues.\n10. Use of Probucol or any lipid-lowering medication other than statins, ezetimibe, and PCSK9 inhibitors within the 30 days prior to enrollment, including bile acid sequestrants, fibrates, and other similar drugs.\n11. Pregnant or breastfeeding individuals, those trying to conceive.\n12. Concurrent participation in another clinical trial involving investigational drugs or devices within the past 30 days.\n13. Planned surgery or intervention that would require discontinuation of the study medication during the study period.\n14. Any reason, known to the participant and investigator, that would prevent the participant from adhering to the study protocol or follow-up.\n15. Other conditions determined by the investigator that may require exclusion.",{"count":51,"type":20},200,"OBSERVATIONAL","The goal of this clinical trial is to evaluate whether the combination of Probucol with statin therapy can reduce the risk of vascular events and improve atherosclerosis outcomes in adults with ischemic stroke and confirmed atherosclerosis. The main questions it aims to answer are:\n\nDoes adding Probucol to statin therapy reduce plaque burden more effectively than statins alone? Does the combination therapy lead to fewer cardiovascular and cerebrovascular events compared to statins alone? Researchers will compare participants receiving standard statin therapy to those receiving statins combined with Probucol to assess differences in plaque burden and the occurrence of vascular events.\n\nParticipants will:\n\nChoose either standard statin therapy (with possible addition of ezetimibe or PCSK9 inhibitors) or the same therapy combined with Probucol 0.5g twice daily.\n\nAttend regular follow-up visits for monitoring atherosclerosis features and cardiovascular health over a 3-year period.\n\nUndergo imaging studies to evaluate changes in atherosclerosis and blood tests to monitor lipid levels and other biomarkers.",[55,56,57,28],"Ischemic Stroke","Atherosclerosis of Artery","Lipid Disorder",[59,28,60,61,62,63],"Probucol","Atherosclerosis","Ischemic stroke","Plaque burden","Lipid-lowering treatment","2025-03-20",{"date":66,"type":33},"2025-03-25",{"date":68,"type":33},"2024-10-17",{"date":70,"type":20},"2027-10",{"name":72,"class":40},"Xuanwu Hospital, Beijing",{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":78,"acronym":4,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":16,"minAge":80,"maxAge":4,"enrollmentInfo":81,"targetDuration":4,"studyType":21,"phases":83,"briefSummary":84,"conditions":85,"keywords":88,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":41},"100577952","phase-4-desifor-expand-mhif-100577952","NCT06804980","DESIFOR-EXPAND (MHIF)","The DEterminig Statin Intolerance for Rosuvastatin Trial","Inclusion Criteria:\n\n* Adult patients (≥ 21 years old) with a prior history of statin intolerance. Statin intolerance is defined by discontinuation of at least 2 different statin medications due to possible side effects. Patients can participate in the trial while on other lipid-lowering agents, such as ezetimibe and PSCK9 inhibitors, as long as the patient has been on the other lipid lowering therapy and tolerating it well for at least 1 month. For individuals with established ASCVD or multiple ASCVD risk factors, initiation of other lipid lowering therapy prior to participation in DESIFOR is encouraged.\n* 2\\. At least 30 days since discontinued use of a statin\n\nExclusion Criteria:\n\n* Women who are pregnant, nursing or attempting to become pregnant\n* Individuals who experienced severe reactions in the past, including rhabdomyolysis, severe myositis, anaphylaxis\n* Individuals who are not otherwise clinically indicated to take rosuvastatin 20 mg","21 Years",{"count":82,"type":20},100,[23],"The DESIFOR pilot study was conducted to determine the feasibility of utilizing an n-of-1 trial to facilitate tolerance of unblinded rosuvastatin in patients with prior statin intolerance",[86,87,28],"Statin Therapy","Statin Adverse Reaction",[89,90,91,92],"Statin Intolerance","lipid-lowering medication","LDL","LDL Cholesterol","2025-01-28",{"date":95,"type":33},"2025-02-03",{"date":97,"type":20},"2025-02-01",{"date":99,"type":20},"2026-12-31",{"name":101,"class":40},"Minneapolis Heart Institute Foundation",{"id":103,"slug":104,"hasResults":11,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":108,"eligibilityCriteria":109,"healthyVolunteers":11,"sex":16,"minAge":110,"maxAge":111,"enrollmentInfo":112,"targetDuration":4,"studyType":21,"phases":114,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":41},"100494970","role-of-coronary-cta-on-lipid-management-and-risk-factors-control-in-an-asymptomatic-chinese-population-100494970","NCT05725096","Role of Coronary CTA on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population","Role of the Screening with Coronary Computed Tomography Angiography on Lipid Management and Risk Factors Control in an Asymptomatic Chinese Population: a Community-based, Prospective Randomised Trial","RESPECT2","Inclusion Criteria:\n\n1. Nanjing residents who have no plans to leave in the next 5 years\n2. Aged from 40 to 69 years\n3. Free of any known clinically cardiovascular disease Able to comprehend and sign an informed consent form\n\nExclusion Criteria:\n\n1. Serious liver dysfunction, defined as AST or ALT \\> 3 times the normal upper limit\n2. Chronic kidney disease (CKD) \\> stage 4, defined as eGFR \\\u003C 30 ml\u002Fmin\u002F1.73 m2\n3. Prior CCTA or invasive coronary angiography within the last 5 years\n4. Any contraindications for CCTA\n5. Previous use of statin or non-statin lipid-lowering medication (such as ezetimibe, PCSK9 inhibitor and XueZhiKang)\n6. Life expectancy \\\u003C 3 years\n7. Other reasons the researcher deems inappropriate to attend","40 Years","69 Years",{"count":113,"type":20},3400,[115],"NA","The primary objective of this study is to determine whether coronary computed tomography angiography (CCTA) -based coronary heart disease(CHD) prevention strategy improves lipid-lowering treatment and cardiovascular risk factor control compared with traditional CHD prevention strategy, guided by a cardiovascular risk score.",[28,118,119,120],"Cardiovascular Risk Factors","Primary Prevention","Adherence, Medication","2024-11-25",{"date":123,"type":33},"2024-11-26",{"date":125,"type":33},"2023-06-28",{"date":127,"type":20},"2027-06",{"name":129,"class":40},"Zhang longjiang,MD",{"id":131,"slug":132,"hasResults":11,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":138,"enrollmentInfo":139,"targetDuration":4,"studyType":21,"phases":141,"briefSummary":142,"conditions":143,"keywords":147,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":150,"lastUpdatePostDateStruct":151,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":41},"100556312","phase-4-statin-combined-with-amlodipine-treats-primary-aldosteronism-100556312","NCT06523465","Statin Combined with Amlodipine Treats Primary Aldosteronism","A Prospective, Multi-center, Randomized Trial to Compare Statin Combined with CCB to MRA Combined with CCB in Primary Aldosteronism Treatment","STOP-PA","Inclusion Criteria:\n\n* Clinical diagnosis of primary aldosteronism\n\nExclusion Criteria:\n\n* Allergy to drugs in this study\n* Pregnancy\n* Severe liver and kidney dysfunction\n* Mental illness","70 Years",{"count":140,"type":20},180,[23],"The drug treatment for primary aldosteronism (PA) is limited and difficult to improve long-term cardiovascular outcomes. This study plans to enroll patients with primary aldosteronism and randomly divide into 3 groups: scheme 1: Statin combined with amlodipine besylate, scheme 2: Statin combined with Spironolactone and Amlodipine besylate. scheme 3: Amlodipine besylate combined with Spironolactone , to observe the changes in plasma aldosterone level, 24-hour urinary aldosterone, blood pressure, and long-term cardiovascular risk.",[144,28,145,146],"Primary Aldosteronism","Mineralocorticoid Receptor Antagonist","Hypertension",[148,149,28],"primary aldosteronism","hypertension","2024-11-19",{"date":152,"type":33},"2024-11-22",{"date":154,"type":33},"2024-09-10",{"date":156,"type":20},"2026-09-30",{"name":158,"class":40},"Third Military Medical University"]