[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Prof. Maurovich-Horvat Pál\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":57},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":4,"hasResults":10,"nctId":11,"briefTitle":12,"officialTitle":12,"acronym":13,"eligibilityCriteria":14,"healthyVolunteers":10,"sex":15,"minAge":16,"maxAge":17,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":36,"overallStatus":45,"whyStopped":4,"lastUpdateSubmitDate":46,"lastUpdatePostDateStruct":47,"startDateStruct":50,"completionDateStruct":52,"leadSponsor":54,"locationsCount":5},"100562453",false,"NCT06603363","Changes in Plaque Characteristics After Short-term Statin Therapy as Assessed With Coronary CT","INTENSE","Inclusion Criteria:\n\n* patients referred for coronary computed tomography angiography (CTA)\n* females aged 45-75 years and males aged 40-75 years\n* presence of at least mild coronary atherosclerosis (luminal stenosis \\>25%, with at least one partially calcified or non-calcified plaque)\n* statin-naive patients\n* ability to understand and provide written informed consent\n* FFR-CT value ≥0.75, indicating the absence of hemodynamically significant stenosis\n\nExclusion Criteria:\n\n* contraindications to coronary CTA\n* current or prior treatment with statins or other lipid-lowering agents (e.g., ezetimibe)\n* age below 45 years in females or below 40 years in males\n* age above 75 years in both sexes\n* pregnancy or breastfeeding\n* type 1 or type 2 diabetes mellitus\n* history of coronary stent implantation or coronary artery bypass grafting\n* history of myocardial infarction\n* ≥70% luminal stenosis in the proximal left anterior descending artery (LAD), or ≥50% stenosis in the left main (LM) coronary artery\n* FFR-CT value \\\u003C0.75 in any coronary artery\n* elevated serum alanine aminotransferase (ALT) levels (\\>3× the upper limit of normal)\n* elevated serum creatine kinase (CK) levels (\\>3× the upper limit of normal)\n* LDL cholesterol level \\>5 mmol\u002FL\n* renal failure or significantly impaired renal function (eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m²)\n* ongoing oncological treatment\n* active liver disease\n* known hypersensitivity to any excipients of the investigational product\n* concomitant treatment with the combination of sofosbuvir\u002Fvelpatasvir\u002Fvoxilaprevir\n* concomitant treatment with cyclosporine\n* women of childbearing potential not using adequate contraception\n* presence of myopathy","ALL","45 Years","75 Years",{"count":19,"type":20},140,"ESTIMATED","INTERVENTIONAL",[23],"NA","INTENSE Trial is a prospective, double-blind, randomized, placebo-controlled, single-center study with two arms (40 mg intensified statin therapy vs matching placebo for rosuvastatin) among statin-naive patients referred to coronary CT angiography due to stable chest pain, followed for 24 months by using a photon-counting detector CT (PCD-CT).\n\nINTENSE Trial aims 1) to assess the effect of short-term intensified statin therapy on coronary anatomy and physiology using PCD-CT and 2) to determine the impact of short-term, intensified statin therapy on coronary plaque morphology and hemodynamics to identify statin responder and non-responder patients in addition to testing the hypothesis of \"plaque memory\" after the 24-month follow-up period.",[26,27,28,29,30,31,32,33,34,35],"Coronary Artery Disease","Atherosclerotic Plaque","Coronary Computed Tomography Angiography","Statin Therapy","Multidetector Computed Tomography","Heart Diseases","Cardiovascular Diseases","Arteriosclerosis","Vascular Diseases","Hyperlipidemia",[37,38,39,40,41,42,43,44],"coronary artery disease","stable chest pain","intermediate pretest probability","explanatory randomised controlled trial","coronary computed tomography angiography","photon-counting detector CT","atherosclerotic plaque","statin therapy","RECRUITING","2026-05-08",{"date":48,"type":49},"2026-05-13","ACTUAL",{"date":51,"type":49},"2025-05-28",{"date":53,"type":20},"2028-12-15",{"name":55,"class":56},"Prof. Maurovich-Horvat Pál","OTHER",""]