[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100576490":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":48,"responsibleParty":65,"collaborators":68,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":33,"enrollmentInfo":80,"targetDuration":33,"studyType":83,"phases":84,"briefSummary":86,"conditions":87,"keywords":91,"overallStatus":94,"whyStopped":33,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":99,"completionDateStruct":101,"leadSponsor":103,"locationsCount":104},{"fullName":5,"class":6},"Erasmus Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention\u002F Atorvastatin arm","EXPERIMENTAL","Patient will receive 20mg of atorvastatin daily together with ICI-therapy",[13],"Drug: Atorvastatin",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo arm","PLACEBO_COMPARATOR","Patient will receive placebo daily together with ICI-therapy",[19],"Drug: Placebo",[21,29],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Atorvastatin","Daily 20mg atorvastatin.",[9],[27,28],"Lipitor","Atorvastatin Mylan",{"type":22,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Placebo","Daily Placebo in combination with ICI-therapy",[15],null,[35],{"name":36,"affiliation":37,"role":38},"Jorie Versmissen, MD,PhD","Department Internal Medicine, Hospital Pharmacy, Erasmus MC Rotterdam","PRINCIPAL_INVESTIGATOR",[40,45],{"name":41,"role":42,"phone":43,"phoneExt":33,"email":44},"Tom Uyl, MD","CONTACT","010-7033202","t.uyl@erasmusmc.nl",{"name":46,"role":42,"phone":43,"phoneExt":33,"email":47},"Jorie Versmissen, MD, PhD","j.versmissen@erasmusmc.nl",[49],{"facility":50,"status":33,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Erasmus Universitair Medisch Cetrum Rotterdam","Rotterdam","South Holland","3015GD","Netherlands","NL",{"type":57,"coordinates":58},"Point",[59,60],4.47917,51.9225,{"lat":60,"lon":59},[63,64],{"name":46,"role":42,"phone":33,"phoneExt":33,"email":47},{"name":41,"role":42,"phone":33,"phoneExt":33,"email":44},{"type":38,"investigatorFullName":66,"investigatorTitle":67,"investigatorAffiliation":5,"oldNameTitle":33,"oldOrganization":33},"Jorie Versmissen","Principal Investigator",[69],{"name":70,"class":6},"Amphia Hospital","100576490","phase-4-statins-to-prevent-immune-checkpoint-inhibitor-induced-progression-of-atheroslerosis-100576490",false,"NCT06785974","Statins to Prevent Immune Checkpoint Inhibitor-induced PRogression of AtherosLerosis","SPIRAL","Inclusion Criteria:\n\n* In order to be eligible to participate in this study, a subject must meet all of the following criteria:\n* Age ≥ 18 years\n* Able to understand the written information and able to give informed consent\n* Melanoma diagnosis with planned ICI treatment according to standard of care (nivolumab, pembrolizumab, monotherapy or combination therapy with ipilimumab)\n* Presence of atherosclerosis in the descending thoracic aorta at baseline.\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Baseline statin use or previously reported statin intolerance\n* Current or recent (≤1 year) history of alcohol or drug abuse\n* Contra-indication for statin therapy, including:\n\n  * Active liver disease, including ALT\u002FAST levels ≥ 3x ULN\n  * (History of) myopathy Congenital muscular disorder History of (drug-induced) rhabdomyolysis History of drug-induced myopathy with elevated creatine kinase (CK)\n  * Severe kidney failure (creatinine clearance \\\u003C 30 ml\u002Fmin)\n* Use of essential medication with (potential) interactions with atorvastatin, including:\n\n  * strong CYP3A4 inhibitors such as clarithromycin, ciclosporin, itraconazol, ketoconazole, voriconazol, posconazol, HCV agents, HIV protease inhibitors\n  * BCRP inhibitors such as elbasvir and grazoprevir\n  * Fibrates (including gemfibrozil)\n* Life expectancy \\\u003C 12 months\n* High MESA-score at baseline","ALL","18 Years",{"count":81,"type":82},140,"ESTIMATED","INTERVENTIONAL",[85],"PHASE4","The goal of this interventional study is to test whether atorvastatin prevents accelerated progression of atherosclerosis in melanoma patients who receive immune checkpoint inhibitor (ICI) therapy. The main questions it aims to answer are:\n\n* difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in the descending thoracic segment of the aorta\n* difference in percentage growth of total atherosclerotic plaque volume (+ calcified and non-calcified plaque volume) in coronary arteries.\n\nResearchers will compare patients that receive ICI-therapy and atorvastatin with patients that receive ICI-therapy + placebo to see if atorvastatin will prevent accelerated ICI induced plaque growth.",[88,89,90],"Atherosclerosis","Melanoma","Immune-related Adverse Event",[92,93],"Statin","Immune Checkpoint Inhibitor","NOT_YET_RECRUITING","2025-01-14",{"date":97,"type":98},"2025-01-22","ACTUAL",{"date":100,"type":82},"2025-02",{"date":102,"type":82},"2030-02",{"name":5,"class":6},1]