[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100638937":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":27,"centralContacts":27,"locations":37,"responsibleParty":249,"collaborators":27,"id":251,"slug":27,"hasResults":252,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":252,"sex":258,"minAge":259,"maxAge":27,"enrollmentInfo":260,"targetDuration":27,"studyType":263,"phases":264,"briefSummary":266,"conditions":267,"keywords":275,"overallStatus":40,"whyStopped":27,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":285,"completionDateStruct":287,"leadSponsor":289,"locationsCount":290},{"fullName":5,"class":6},"Instituto de Investigación Marqués de Valdecilla","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group: Carotid Ultrasound","EXPERIMENTAL","Patients undergo carotid ultrasound within 30 days of randomization. Patients with carotid plaques are reclassified as very high cardiovascular risk and initiated on high-intensity statin therapy (LDL target \\\u003C 55 mg\u002FdL). Patients without carotid plaques are managed according to ESC 2021 guidelines.",[13,14],"Diagnostic Test: Carotid Ultrasound","Drug: High-intensity lipid-lowering therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Control Group: Standard Care","ACTIVE_COMPARATOR","Patients are managed according to standard ESC 2021 cardiovascular prevention guidelines throughout the study, without carotid ultrasound assessment.",[20],"Other: Standard care according to ESC 2021 guidelines",[22,28,33],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DIAGNOSTIC_TEST","Carotid Ultrasound","Carotid ultrasound performed to detect subclinical atherosclerosis (carotid plaques) according to Manheim consensus criteria. The presence of carotid plaques triggers reclassification to very high cardiovascular risk and initiation of high-intensity lipid-loqering therapy",[9],null,{"type":29,"name":30,"description":31,"armGroupLabels":32,"otherNames":27},"DRUG","High-intensity lipid-lowering therapy","Sequential lipid-lowering therapy initiated in experimental group patinets with carotid plaques, targeting LDL \\\u003C 55 mg\u002FdL. Treatment includes high-intensity statins (atorvastatin 40-80mg, rouvastatin 20-40mg), with possible addition of azetimibe, bempedoic acid, and\u002For PCSK9 inhibitors if target is not achieved.",[9],{"type":6,"name":34,"description":35,"armGroupLabels":36,"otherNames":27},"Standard care according to ESC 2021 guidelines","Lipid-lowerin treatment indicated and managed according to ESC 2021 cardiovascular prevention guidelines, based on SCORE\u002FOP risk stratification, without carotid ultrasound assessment",[16],[38,55,68,80,92,105,117,129,141,153,166,179,191,200,212,223,236],{"facility":39,"status":40,"city":41,"state":41,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"Hospital General Universitario de Alicante","RECRUITING","Alicante","Spain","ES",{"type":45,"coordinates":46},"Point",[47,48],-0.48149,38.34517,{"lat":48,"lon":47},[51],{"name":52,"role":53,"phone":27,"phoneExt":27,"email":54},"Cristina Fenandez Carballido","CONTACT","soficarballido@hotmail.com",{"facility":56,"status":57,"city":58,"state":41,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"Hospital Universitario de Elche","NOT_YET_RECRUITING","Elche",{"type":45,"coordinates":60},[61,62],-0.70107,38.26218,{"lat":62,"lon":61},[65],{"name":66,"role":53,"phone":27,"phoneExt":27,"email":67},"Cynthia Romera Lopez","CYNTHIA.ROMERA.LOPEZ@hotmail.com",{"facility":69,"status":40,"city":70,"state":41,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":71,"geoPoint":75,"contacts":76},"Hospital Vega Baja de Orihuela","Orihuela",{"type":45,"coordinates":72},[73,74],-0.94401,38.08483,{"lat":74,"lon":73},[77],{"name":78,"role":53,"phone":27,"phoneExt":27,"email":79},"Maria Paz Martinez Vidal","mpmavidal@yahoo.es",{"facility":81,"status":40,"city":82,"state":82,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"Hospital Universitario Vall d'Hebrón","Barcelona",{"type":45,"coordinates":84},[85,86],2.15899,41.38879,{"lat":86,"lon":85},[89],{"name":90,"role":53,"phone":27,"phoneExt":27,"email":91},"Alba Erra Duran","alba.erra@vallhebron.cat",{"facility":93,"status":40,"city":94,"state":95,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Hospital de Laredo","Laredo","Cantabria",{"type":45,"coordinates":97},[98,99],-3.41613,43.4098,{"lat":99,"lon":98},[102],{"name":103,"role":53,"phone":27,"phoneExt":27,"email":104},"Cristina Corrales","c.corrales.selaya@gmail.com",{"facility":106,"status":57,"city":107,"state":95,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"Hospital Universitario Marqués de Valdecilla","Santander",{"type":45,"coordinates":109},[110,111],-3.80493,43.46589,{"lat":111,"lon":110},[114],{"name":115,"role":53,"phone":27,"phoneExt":27,"email":116},"Vanesa Calvo Rio","vcalvorio@gmail.com",{"facility":118,"status":40,"city":119,"state":95,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":120,"geoPoint":124,"contacts":125},"Hospital Sierrallana","Torrelavega",{"type":45,"coordinates":121},[122,123],-4.04785,43.34943,{"lat":123,"lon":122},[126],{"name":127,"role":53,"phone":27,"phoneExt":27,"email":128},"Javier Rueda Gotor","ruedagotor@gmail.com",{"facility":130,"status":57,"city":131,"state":131,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Hospital General Universitario de Ciudad Real","Ciudad Real",{"type":45,"coordinates":133},[134,135],-3.92907,38.98626,{"lat":135,"lon":134},[138],{"name":139,"role":53,"phone":27,"phoneExt":27,"email":140},"David Castro Corredor","d.castrocorredor@gmail.com",{"facility":142,"status":57,"city":143,"state":143,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Hospital Universitario Reina Sofía","Córdoba",{"type":45,"coordinates":145},[146,147],-4.77275,37.89155,{"lat":147,"lon":146},[150],{"name":151,"role":53,"phone":27,"phoneExt":27,"email":152},"Maria Angeles Puche Larrubia","mangeles.puche@gmail.com",{"facility":154,"status":57,"city":155,"state":156,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":157,"geoPoint":161,"contacts":162},"Hospital Universitari Son LLàtzer","Palma","Isla Baleares",{"type":45,"coordinates":158},[159,160],2.65024,39.56939,{"lat":160,"lon":159},[163],{"name":164,"role":53,"phone":27,"phoneExt":27,"email":165},"Inmaculada Ros Vilamajóv","iros@hsll.es",{"facility":167,"status":57,"city":168,"state":169,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Hospital Universitario de Gran Canaria Dr. Negrín","Las Palmas de Gran Canaria","Las Palmas",{"type":45,"coordinates":171},[172,173],-15.41573,28.10178,{"lat":173,"lon":172},[176],{"name":177,"role":53,"phone":27,"phoneExt":27,"email":178},"Ivan Ferraz Amaro","iferrazamaro@hotmail.com",{"facility":180,"status":57,"city":181,"state":181,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":182,"geoPoint":186,"contacts":187},"Hospital Universitario La Paz","Madrid",{"type":45,"coordinates":183},[184,185],-3.70256,40.4165,{"lat":185,"lon":184},[188],{"name":189,"role":53,"phone":27,"phoneExt":27,"email":190},"Eugenio de Miguel Mendieta","eugenio.demiguel@gmail.com",{"facility":192,"status":57,"city":181,"state":181,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":193,"geoPoint":195,"contacts":196},"Hospital Universitario Ramón y Cajal",{"type":45,"coordinates":194},[184,185],{"lat":185,"lon":184},[197],{"name":198,"role":53,"phone":27,"phoneExt":27,"email":199},"Marta Valero Expósito","martavaleroex@yahoo.es",{"facility":201,"status":57,"city":202,"state":202,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":203,"geoPoint":207,"contacts":208},"Hispital Universitario Virgen de la Arrixaca","Murcia",{"type":45,"coordinates":204},[205,206],-1.13004,37.98704,{"lat":206,"lon":205},[209],{"name":210,"role":53,"phone":27,"phoneExt":27,"email":211},"Manuel Jose Moreno Ramos","mjmorenoramos@gmail.com",{"facility":213,"status":57,"city":214,"state":215,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":216,"geoPoint":220,"contacts":221},"Hospital Universitario de Canarias","San Cristóbal de La Laguna","Santa Cruz de Tenerife",{"type":45,"coordinates":217},[218,219],-16.32014,28.4853,{"lat":219,"lon":218},[222],{"name":177,"role":53,"phone":27,"phoneExt":27,"email":178},{"facility":224,"status":40,"city":225,"state":226,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":227,"geoPoint":231,"contacts":232},"Hospital Universitario de Basurto","Bilbao","Vizcaya",{"type":45,"coordinates":228},[229,230],-2.92528,43.26271,{"lat":230,"lon":229},[233],{"name":234,"role":53,"phone":27,"phoneExt":27,"email":235},"Maria Luz Garcia Vivar","marilugv@hotmail.com",{"facility":237,"status":40,"city":238,"state":239,"zip":27,"country":42,"countryCode":43,"cosmosGeoPoint":240,"geoPoint":244,"contacts":245},"Hospital Universitario Araba","Vitoria-Gasteiz","Álava",{"type":45,"coordinates":241},[242,243],-2.67268,42.84998,{"lat":243,"lon":242},[246],{"name":247,"role":53,"phone":27,"phoneExt":27,"email":248},"Jaime Calvo Allen","jcalvo@ser.es",{"type":250,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100638937",false,"NCT07611747","Carotid Ultrasound-Based Strategy for Primary Prevention of Cardiovascular Events in Inflammatory Rheumatic Disease (PREVENER)","Randomized Clinical Trial to Assess the Efficacy and Safety of a Primary Prevention Strategy for Cardiovascular Events in Patients With Inflammatory Rheumatic Diseases Based on the Use of Carotid Ultrasound","PREVENER","Inclusion Criteria:\n\n1. Patients aged ≥50 years who have provided written informed consent.\n2. Fulfillment of classification criteria for at least one of the following inflammatory rheumatic diseases:\n\n   * Rheumatoid arthritis (RA) according to ACR\u002FEULAR 2010 criteria\n   * Psoriatic arthritis (PsA) according to CASPAR criteria\n   * Axial spondyloarthritis (AxSpA) according to ASAS criteria\n   * Systemic lupus erythematosus (SLE) according to ACR\u002FEULAR 2019 criteria\n3. Low-to-moderate cardiovascular risk according to SCORE2\u002FOP classification.\n\nExclusion Criteria:\n\n1. Presence of previous cardiovascular events, type 2 diabetes mellitus, familial hypercholesterolemia, or chronic kidney disease resulting in classification as high or very high cardiovascular risk.\n2. Prior carotid ultrasound examination with subsequent therapeutic intervention derived from its results, either in the context of a research study or routine clinical practice.\n3. Contraindications to lipid-lowering therapy, including recent history of alcoholism, active liver disease, or unexplained and persistent elevation of serum transaminases exceeding three times the upper limit of normal (applicable to statins and ezetimibe).","ALL","50 Years",{"count":261,"type":262},1944,"ESTIMATED","INTERVENTIONAL",[265],"PHASE4","PREVENER is a randomized, open-label, multicenter, phase IV clinical trial designed to evaluate the efficacy and safety of a carotid ultrasound-based strategy for the primary prevention of cardiovascular events in patients with inflammatory rheumatic diseases (IRD).\n\nPatients with IRD, including rheumatoid arthritis (RA), psoriatic arthritis (PsA), axial spondyloarthritis (AxSpA), and systemic lupus erythematosus (SLE), have a 50% higher risk of cardiovascular (CV) events compared to the general population. However, conventional CV risk scores (SCORE2\u002FOP) systematically underestimate this risk, leaving many high-risk patients without appropriate preventive treatment.\n\nPatients aged ≥50 years with IRD and low-to-moderate CV risk according to SCORE2\u002FOP will be randomized 1:1 to either an experimental group (carotid ultrasound to detect subclinical atherosclerosis) or a control group (standard care according to ESC 2021 guidelines). Patients in the experimental group with carotid plaques will be reclassified as very high CV risk and treated with high-intensity statins (LDL target \\\u003C55 mg\u002FdL). The primary endpoint is the incidence of major adverse cardiovascular events (MACE) over 48 months of follow-up.",[268,269,270,271,272,273,274],"Rheumatoid Arthritis (RA)","Psoriatic Arthritis (PsA)","Axial Spondy","Systemic Lupus Erythematosus (SLE)","Caridovascular Disease","Atherosclerosis","Carotid Artery Diseases",[276,277,278,279,280],"Carotid ultrasound","Carotid plaques","Subclinical atherosclerosis","Cardiovascular prevention","Inflammatory rheumatic diseases","2026-05-20",{"date":283,"type":284},"2026-05-28","ACTUAL",{"date":286,"type":284},"2026-04-22",{"date":288,"type":262},"2031-12",{"name":5,"class":6},17]