[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100595610":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":28,"centralContacts":32,"locations":38,"responsibleParty":51,"collaborators":24,"id":53,"slug":54,"hasResults":55,"nctId":56,"briefTitle":57,"officialTitle":58,"acronym":59,"eligibilityCriteria":60,"healthyVolunteers":55,"sex":61,"minAge":62,"maxAge":63,"enrollmentInfo":64,"targetDuration":24,"studyType":67,"phases":68,"briefSummary":70,"conditions":71,"keywords":73,"overallStatus":41,"whyStopped":24,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Novartis","INDUSTRY",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention group","OTHER","Participants receive Health Education Intervention alongside standard of care",[13,14],"Other: Educational Material","Other: Standard of care",{"label":16,"type":10,"description":17,"interventionNames":18},"Control Group","Participants receive Standard of care",[14],[20,25],{"type":10,"name":21,"description":22,"armGroupLabels":23,"otherNames":24},"Educational Material","Health Education Intervention delivered via clinic visits (every 4 months) and virtual sessions (between each clinic visit)",[9],null,{"type":10,"name":26,"description":26,"armGroupLabels":27,"otherNames":24},"Standard of care",[16,9],[29],{"name":30,"affiliation":30,"role":31},"Novartis Pharmaceuticals","STUDY_DIRECTOR",[33,37],{"name":30,"role":34,"phone":35,"phoneExt":24,"email":36},"CONTACT","+41613241111","novartis.email@novartis.com",{"name":30,"role":34,"phone":24,"phoneExt":24,"email":36},[39],{"facility":40,"status":41,"city":42,"state":24,"zip":24,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":24},"Novartis Investigative Site","RECRUITING","Abu Dhabi","United Arab Emirates","AE",{"type":46,"coordinates":47},"Point",[48,49],54.39696,24.45118,{"lat":49,"lon":48},{"type":52,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR","100595610","phase-4-study-to-evaluate-the-impact-of-a-targeted-lipid-optimization-program-on-ldl-c-control-in-at-risk-adult-patients-with-dyslipidemia-100595610",false,"NCT07034690","Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in At-risk Adult Patients With Dyslipidemia","A Prospective, Type I Hybrid Effectiveness-implementation, Open Label, Randomized Study to Evaluate the Impact of a Targeted Lipid Optimization Program on LDL-C Control in at- Risk Adult Patients From Abu Dhabi, United Arab Emirates (UAE) With Dyslipidemia","OPTIMA","Inclusion Criteria:\n\n* Diagnosis of ASCVD (coronary heart disease, peripheral arterial disease and\u002For cerebrovascular disease)\n* High risk or very high risk for cardiovascular events (as per the 2019 ESC\u002FEAS guidelines \\[1\\] for the management of dyslipidemias)\n* Lipid levels:\n\n  * High risk: LDL-C ≥70 mg\u002Fdl (or \\> 1.8 mmol\u002FL) or non-HDL-C ≥100 mg\u002Fdl\n  * Very high risk: LDL-C ≥55 mg\u002Fdl (or \\> 1.4 mmol\u002FL) or non-HDL-C ≥85 mg\u002Fdl\n* Male or Female\n* 18 years or older\n* Seen by a specialist who is prescribing advanced lipid lowering treatments (LLTs) (cardiologist, endocrinologist or any other relevant specialist)\n* Currently taking maximum-tolerated statins\n* Ability to participate in educational program (must be able to watch online videos)\n* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.\n\nExclusion Criteria:\n\n* Any surgical or medical condition, which in the opinion of the Investigator, may place the participant at higher risk from his\u002Fher participation in the study, or is likely to prevent the participant from complying with the requirements of the study or completing the study.\n* Unwillingness or inability (e.g., physical or cognitive) to comply with study procedures (including adherence to study visits).\n* Participation in any other interventional study.\n* Inability to travel to study sites for in-person clinic visits.\n* Responsible physician clinical decision not to engage the identified patient.\n* Refusal of the potential participant to sign the consent and be included in the model.\n\nOther protocol-defined inclusion\u002Fexclusion criteria may apply","ALL","18 Years","100 Years",{"count":65,"type":66},326,"ESTIMATED","INTERVENTIONAL",[69],"PHASE4","This study is an open label, randomized, prospective, type I hybrid effectiveness- implementation, pragmatic clinical trial to evaluate the impact of a targeted lipid optimization program on LDL-C control in participants with dyslipidemia who are at high risk or very high risk of cardiovascular events.",[72],"Atherosclerotic Cardiovascular Disease",[74,75,76,77,78,79],"Dyslipidemia,","ASCVD,","lipid optimization program,","LDL-C target,","educational intervention,","hybrid effectiveness-implementation study","2026-04-28",{"date":82,"type":83},"2026-05-04","ACTUAL",{"date":85,"type":83},"2025-11-26",{"date":87,"type":66},"2028-05-31",{"name":30,"class":6},1]