[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554619":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":37,"locations":43,"responsibleParty":134,"collaborators":26,"id":136,"slug":137,"hasResults":138,"nctId":139,"briefTitle":140,"officialTitle":141,"acronym":26,"eligibilityCriteria":142,"healthyVolunteers":138,"sex":143,"minAge":144,"maxAge":145,"enrollmentInfo":146,"targetDuration":26,"studyType":149,"phases":150,"briefSummary":152,"conditions":153,"keywords":155,"overallStatus":46,"whyStopped":26,"lastUpdateSubmitDate":161,"lastUpdatePostDateStruct":162,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Usual Care","ACTIVE_COMPARATOR","Patients will receive what is the usual care in their respective countries. Usual care includes physical activity, diet modification, pharmacological therapy as: statin therapy (rosuvastatin, atorvastatin, simvastatin, pravastatin, lovastatin, fluvastatin, pitavastatin), ezetimibe, cholestyramine or bempedoic acid.",[13],"Drug: Usual care",{"label":15,"type":16,"description":17,"interventionNames":18},"Inclisiran + Usual Care","EXPERIMENTAL","Patients will receive what is usual care in their countries plus inclisiran 284 mg at baseline, 90 days, and 270 days.",[13,19],"Drug: KJX839",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Usual care","Treatment after acute event approved in the country where patient is based. It may include educational intervention according to each country guidelines",[15,9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"KJX839","Inclisiran in solution for subcutaneous injection on day 1, day 90, and day 270",[15],[32],"Inclisiran",[34],{"name":35,"affiliation":35,"role":36},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[38,42],{"name":35,"role":39,"phone":40,"phoneExt":26,"email":41},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":35,"role":39,"phone":26,"phoneExt":26,"email":26},[44,57,68,77,82,91,100,110,118,126,129],{"facility":45,"status":46,"city":47,"state":26,"zip":48,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":26},"Novartis Investigative Site","RECRUITING","Corrientes","W3400CDS","Argentina","AR",{"type":52,"coordinates":53},"Point",[54,55],-58.8344,-27.46784,{"lat":55,"lon":54},{"facility":45,"status":46,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":67,"contacts":26},"Salvador","Estado de Bahia","40170-130","Brazil","BR",{"type":52,"coordinates":64},[65,66],-38.49096,-12.97563,{"lat":66,"lon":65},{"facility":45,"status":46,"city":69,"state":70,"zip":71,"country":61,"countryCode":62,"cosmosGeoPoint":72,"geoPoint":76,"contacts":26},"Belo Horizonte","Minas Gerais","30000",{"type":52,"coordinates":73},[74,75],-43.93778,-19.92083,{"lat":75,"lon":74},{"facility":45,"status":46,"city":69,"state":70,"zip":78,"country":61,"countryCode":62,"cosmosGeoPoint":79,"geoPoint":81,"contacts":26},"30110-934",{"type":52,"coordinates":80},[74,75],{"lat":75,"lon":74},{"facility":45,"status":46,"city":83,"state":84,"zip":85,"country":61,"countryCode":62,"cosmosGeoPoint":86,"geoPoint":90,"contacts":26},"Campo Largo","Paraná","83606-177",{"type":52,"coordinates":87},[88,89],-49.53014,-25.45955,{"lat":89,"lon":88},{"facility":45,"status":46,"city":92,"state":93,"zip":94,"country":61,"countryCode":62,"cosmosGeoPoint":95,"geoPoint":99,"contacts":26},"Porto Alegre","Rio Grande do Sul","90560-032",{"type":52,"coordinates":96},[97,98],-51.23019,-30.03283,{"lat":98,"lon":97},{"facility":45,"status":101,"city":102,"state":103,"zip":104,"country":61,"countryCode":62,"cosmosGeoPoint":105,"geoPoint":109,"contacts":26},"WITHDRAWN","Blumenau","Santa Catarina","89010-500",{"type":52,"coordinates":106},[107,108],-49.06611,-26.91944,{"lat":108,"lon":107},{"facility":45,"status":46,"city":111,"state":103,"zip":112,"country":61,"countryCode":62,"cosmosGeoPoint":113,"geoPoint":117,"contacts":26},"São José","88103-901",{"type":52,"coordinates":114},[115,116],-48.6275,-27.61528,{"lat":116,"lon":115},{"facility":45,"status":46,"city":111,"state":119,"zip":120,"country":61,"countryCode":62,"cosmosGeoPoint":121,"geoPoint":125,"contacts":26},"São Paulo","15015-110",{"type":52,"coordinates":122},[123,124],-45.16947,-22.87874,{"lat":124,"lon":123},{"facility":45,"status":46,"city":127,"state":26,"zip":128,"country":61,"countryCode":62,"cosmosGeoPoint":26,"geoPoint":26,"contacts":26},"Campina Gde Do Sul","83430 000",{"facility":45,"status":46,"city":58,"state":26,"zip":130,"country":61,"countryCode":62,"cosmosGeoPoint":131,"geoPoint":133,"contacts":26},"40323-010",{"type":52,"coordinates":132},[65,66],{"lat":66,"lon":65},{"type":135,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100554619","phase-4-latam-lowers-ldl-c-100554619",false,"NCT06501443","LATAM LOWERS LDL-C","Latin America Lipid Optimization After Acute Event in Patients With AthErosclerotic CardiovasculaR DiseaSe and High LDL-C","Inclusion Criteria:\n\n* Admitted for MI (Type 1 NSTEMI or STEMI), urgent (i.e., non-elective) coronary revascularization (PCI or CABG) or confirmed ischemic stroke.\n* Stable patient: Patient will be considered stable if they did not suffer cardiac arrest at presentation or if in the last 24 hours before randomization:\n\n  * Was not in cardiogenic shock.\n  * Did not required invasive hemodynamic, inotropic or vasopressor support.\n* Participants are required to be eligible for receiving inclisiran in accordance to approved local label.\n\n  * Of note, patients who are initiated on statin therapy during the same hospitalization will not be excluded, as we expect a proportion of patients at baseline to not yet be on statin therapy in this real-world study. This will enhance the generalizability and pragmatic aspects of the study. However, because initiation of statin therapy at or near the time of enrollment could impact the primary outcome (if there is imbalance between the arms, or if there is differential stopping of statin therapy between the arms), we will stratify randomization by this factor and will pre-specify analyses in those who have vs. have not been initiated on statin therapy during the same hospitalization.\n\nExclusion Criteria:\n\n* Currently on PCSK9i therapy (within last 3 months)\n* Current participation in another clinical study with another study drug\n* Active liver disease defined as any known current infectious, neoplastic, or metabolic pathology of the liver at the Baseline Visit\n* Pregnant or nursing (lactating) women\n* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception","ALL","18 Years","100 Years",{"count":147,"type":148},520,"ESTIMATED","INTERVENTIONAL",[151],"PHASE4","This is an open label, patient-level 1:1 randomized clinical trial in a multi-country study aiming to evaluate the real-world impact of inclisiran + Usual Care (UC) vs UC alone on LDL-C lowering, patient-reported outcomes, and healthcare resource utilization in an in-hospital population of patients, admitted during the acute setting, stabilized and before discharge, following an acute cardiovascular event.",[154],"Hypercholesterolaemia",[156,157,158,159,160],"PCSK9i","hypercholesterolemia","atherosclerotic cardiovascular disease","LDL-cholesterol","Latin America","2025-12-22",{"date":163,"type":164},"2025-12-30","ACTUAL",{"date":166,"type":164},"2025-02-11",{"date":168,"type":148},"2026-11-29",{"name":35,"class":6},11]