[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100504218":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":35,"locations":45,"responsibleParty":62,"collaborators":26,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":26,"enrollmentInfo":74,"targetDuration":26,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":26,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":94},{"fullName":5,"class":6},"Samsung Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Aggressive treatment arm","EXPERIMENTAL","In this group, high-intensity statin (rosuvastatin 20mg) combined with ezetimibe 10 mg will be prescribed regardless of patients' age, concomitant diabetes mellitus, or ASCVD risk.",[13],"Drug: High intensity statin plus ezetimibe therapy",{"label":15,"type":16,"description":17,"interventionNames":18},"Standard treatment arm","ACTIVE_COMPARATOR","In this group, lipid lowering therapy will be followed according to the current guideline recommendation. A moderate-intensity statin (rosuvastatin 5 mg) will be prescribed for patients over 75 years of age or with diabetes mellitus. For non-diabetic patients aged 40-75 years, the use of statins will be determined by calculating the ASCVD risk score. (ASCVD risk \\\u003C7.5%: no statin use, ≥7.5 - \\\u003C20%: moderate-intensity statin \\[rosuvastatin 5mg\\], ≥ 20%: high-intensity statin \\[rosuvastatin 20mg\\])",[19],"Drug: Guideline directed statin therapy",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Guideline directed statin therapy","At least moderate intensity statin, recommended by the current guideline based on the ASCVD risk",[15],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"High intensity statin plus ezetimibe therapy","Rosuvastatin 20 mg + Ezetimibe 10 mg",[9],[32],{"name":33,"affiliation":5,"role":34},"Seung-Hyuk Choi","PRINCIPAL_INVESTIGATOR",[36,41],{"name":37,"role":38,"phone":39,"phoneExt":26,"email":40},"Seung-Hyuk Choi, MD","CONTACT","82-2-3410-3419","sh1214.choi@samsung.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Ki Hong Choi, MD","82-2-3410-6653","cardiokh@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":26,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"SamsungMedicalCenter","RECRUITING","Seoul","06351","South Korea",{"type":53,"coordinates":54},"Point",[55,56],126.9784,37.566,{"lat":56,"lon":55},[59],{"name":60,"role":38,"phone":61,"phoneExt":26,"email":26},"Seunghyuk Choi, PhMD","82-2-3410-3437",{"type":34,"investigatorFullName":33,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"Professor","100504218","phase-4-high-intensity-statin-and-ezetimibe-therapy-for-asymptomatic-patients-with-positive-coronary-calcium-100504218",false,"NCT05845424","High-intensity Statin and Ezetimibe Therapy for Asymptomatic Patients With Positive Coronary Calcium","Comparison of Efficacy and Safety of High-Intensity Statin and Ezetimibe Combination Versus StanDard carE in AsymptomatiC PatIentS wIth Presence of COroNary Artery CALCIUM (DECISION-CAL)","DECISION-CAL","Inclusion Criteria:\n\n* Subject must be at least 40 years of age.\n* Asymptomatic patients with presence of coronary calcification (Agatston Score ≥ 100)\n* low-density lipoproteins cholesterol (LDL-C) \\\u003C190 mg\u002FdL\n\nExclusion Criteria:\n\n* Objective evidence of at least moderate inducible ischemia requiring revascularization treatment\n* History of cerebrovascular disease\n* History of coronary or peripheral arterial revascularization\n* Active liver disease or persistent unexplained serum transaminase elevations more than 2 times the upper limit of normal range\n* History of any adverse drug reaction requiring discontinuation of statin (e, g. rhabdomyolysis)\n* Allergy or sensitivity to any statin or ezetimibe\n* Concurrent treatment with cyclosporine or a condition likely to result in organ transplantation and the need for cyclosporine\n* Pregnancy or breast feeding\n* Non-cardiac co-morbid conditions are present with life expectancy \\\u003C1 year or that may result in protocol non-compliance (per site investigator's medical judgment)\n* Unwillingness or inability to comply with the procedures described in this protocol.","ALL","40 Years",{"count":75,"type":76},6000,"ESTIMATED","INTERVENTIONAL",[79],"PHASE4","The aim of this study is to compare safety and efficacy between the aggressive treatment with combination of high-intensity statin and ezetimibe and the current standard lipid lowering treatment in asymptomatic patients with presence of coronary calcification.",[82,83,84],"Coronary Artery Calcification","Metabolic Syndrome","Dyslipidemias","2025-01-12",{"date":87,"type":88},"2025-01-14","ACTUAL",{"date":90,"type":88},"2023-07-03",{"date":92,"type":76},"2030-06-30",{"name":5,"class":6},1]