[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100562453":3},{"organization":4,"armGroups":7,"interventions":22,"overallOfficials":48,"centralContacts":60,"locations":65,"responsibleParty":81,"collaborators":85,"id":92,"slug":34,"hasResults":93,"nctId":94,"briefTitle":95,"officialTitle":95,"acronym":96,"eligibilityCriteria":97,"healthyVolunteers":93,"sex":98,"minAge":99,"maxAge":100,"enrollmentInfo":101,"targetDuration":34,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":119,"overallStatus":68,"whyStopped":34,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Semmelweis University","OTHER",[8,16],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensified Statin Arm","EXPERIMENTAL","Participants will receive one capsule (40 mg of rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit, the dose will be reduced to a dose per standard of care.",[13,14,15],"Drug: Rosuvastatin 40mg","Diagnostic Test: Coronary Computed Tomography Angiography (Coronary CTA)","Diagnostic Test: Blood test",{"label":17,"type":18,"description":19,"interventionNames":20},"Placebo Arm","PLACEBO_COMPARATOR","Participants will receive one capsule (a placebo for rosuvastatin), taken once daily for 3 months, orally with or without food. After the 3-month visit standard rosuvastatin therapy will be initiated.",[21,14,15],"Drug: Placebo",[23,30,35,42],{"type":24,"name":25,"description":26,"armGroupLabels":27,"otherNames":28},"DRUG","Rosuvastatin 40mg","Participants will receive 40 mg of rosuvastatin once a day for 3 months. After the 3-month visit, the dose will be reduced to a dose per standard of care.",[9],[29],"Intensified Statin Therapy",{"type":24,"name":31,"description":32,"armGroupLabels":33,"otherNames":34},"Placebo","Participants will receive a placebo for rosuvastatin once a day for 3 months. After the 3-month visit, standard rosuvastatin will be initiated.",[17],null,{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":40},"DIAGNOSTIC_TEST","Coronary Computed Tomography Angiography (Coronary CTA)","Computed Tomography Angiography including coronary calcium scoring and coronary computed tomography angiography at baseline, 3-month, and 24-month visits with a PCD-CT scanner.",[9,17],[41],"Coronary CTA",{"type":36,"name":43,"description":44,"armGroupLabels":45,"otherNames":46},"Blood test","Blood test at baseline, 3-month, and 24-month visits.",[9,17],[47],"Laboratory test",[49,53,57],{"name":50,"affiliation":51,"role":52},"Pál Maurovich-Horvat, Prof., Dr.","Medical Imaging Centre, Budapest, Hungary","PRINCIPAL_INVESTIGATOR",{"name":54,"affiliation":55,"role":56},"Marc Dewey, Prof., Dr.","Charite University, Berlin, Germany","STUDY_CHAIR",{"name":58,"affiliation":59,"role":56},"Béla Merkely, Prof., Dr.","Heart and Vascular Centre, Budapest, Hungary",[61],{"name":50,"role":62,"phone":63,"phoneExt":34,"email":64},"CONTACT","+36206632485","maurovich-horvat.pal@semmelweis.hu",[66],{"facility":67,"status":68,"city":69,"state":69,"zip":70,"country":71,"cosmosGeoPoint":72,"geoPoint":77,"contacts":78},"Semmelweis University, Medical Imaging Centre","RECRUITING","Budapest","1082","Hungary",{"type":73,"coordinates":74},"Point",[75,76],19.04045,47.49835,{"lat":76,"lon":75},[79],{"name":80,"role":62,"phone":63,"phoneExt":34,"email":64},"Pál Maurovich-Horvat, MD, PhD, DSc",{"type":82,"investigatorFullName":83,"investigatorTitle":84,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"SPONSOR_INVESTIGATOR","Prof. Maurovich-Horvat Pál","Head of Clinic for Medical Imaging",[86,89],{"name":87,"class":88},"National Research, Development and Innovation Office, Hungary","UNKNOWN",{"name":90,"class":91},"HeartFlow, Inc.","INDUSTRY","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":102,"type":103},140,"ESTIMATED","INTERVENTIONAL",[106],"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.",[109,110,111,112,113,114,115,116,117,118],"Coronary Artery Disease","Atherosclerotic Plaque","Coronary Computed Tomography Angiography","Statin Therapy","Multidetector Computed Tomography","Heart Diseases","Cardiovascular Diseases","Arteriosclerosis","Vascular Diseases","Hyperlipidemia",[120,121,122,123,124,125,126,127],"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","2026-05-08",{"date":130,"type":131},"2026-05-13","ACTUAL",{"date":133,"type":131},"2025-05-28",{"date":135,"type":103},"2028-12-15",{"name":83,"class":6},1]