[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659977":3},{"organization":4,"outcomesModule":7,"designInfo":35,"detailedDescription":41,"studyPopulation":34,"armGroups":42,"interventions":59,"overallOfficials":34,"centralContacts":73,"locations":79,"responsibleParty":98,"collaborators":102,"id":106,"slug":107,"hasResults":108,"nctId":109,"briefTitle":110,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":108,"sex":113,"minAge":114,"maxAge":115,"enrollmentInfo":116,"targetDuration":34,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":128,"whyStopped":34,"lastUpdateSubmitDate":129,"lastUpdatePostDateStruct":130,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":138},{"fullName":5,"class":6},"Yonsei University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":34},[9],{"measure":10,"description":11,"timeFrame":12},"discontinuation or drug change of the study drug due to intolerance","Incidence rate of \"discontinuation or drug change of the study drug due to intolerance\" up to one year in time","Verified for 1 year after registration",[14,17,21,24,27,31],{"measure":15,"description":16,"timeFrame":12},"New-Onset Diabetes Mellitus (NODM)","New-Onset Diabetes Mellitus (NODM): Defined as HbA1c ≥ 6.5% (FPG ≥ 126 mg\u002FdL is excluded from the diagnostic criteria)",{"measure":18,"description":19,"timeFrame":20},"HbA1c","12-month change in HbA1c compared to baseline","Check after 12 months of registration",{"measure":22,"description":23,"timeFrame":20},"LDL-C target achievement rate","LDL-C target achievement rate (target achievement rate: LDL-C \\\u003C 100 mg\u002FdL Criteria)",{"measure":25,"description":26,"timeFrame":20},"LDL-C levels","LDL-C levels for 12 months",{"measure":28,"description":29,"timeFrame":30},"Medication possession ratio","Medication possession ratio (MPR - total number of days of prescription or dispensing \u002F observing institution): rate of achievement of 80% or higher and average MPR","Verified for 12 months after registration",{"measure":32,"description":33,"timeFrame":30},"Adverse Event (AE) incidence","Adverse Event (AE) incidence: elevated AST\u002FALT, elevated CPK, SAMS, myopathy, rhabdomyolysis, and other adverse drug reactions",null,{"allocation":36,"interventionModel":37,"interventionModelDescription":34,"primaryPurpose":38,"observationalModel":34,"timePerspective":34,"maskingInfo":39},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":40,"maskingDescription":34,"whoMasked":34},"NONE","This study compares three low-dose statin\u002Fezetimibe combination drugs (rosuvastatin\u002Fezetimibe 2.5\u002F10 mg, atorvastatin\u002Fezetimibe 5\u002F10 mg, pitavastatin\u002Fezetimibe 1\u002F10 mg) currently marketed in Korea in a randomized trial of patients with minimal subclinical atherosclerosis.\n\nBy using 'drug discontinuation\u002Freduction due to intolerance' as the primary endpoint, we aim to evaluate clinically meaningful tolerability in the field, while also assessing NODM occurrence, HbA1c changes, LDL-C target attainment, and drug adherence to provide a clinical rationale for a 'personalized low-dose lipid-lowering strategy.'",[43,49,54],{"label":44,"type":45,"description":46,"interventionNames":47},"Rosuvastatin\u002Fezetimibe 2.5\u002F10mg","EXPERIMENTAL","participants receive Rosuvastatin\u002Fezetimibe 2.5\u002F10mg (Crezet 2.5\u002F10mg)",[48],"Drug: Crezet 2.5\u002F10mg",{"label":50,"type":45,"description":51,"interventionNames":52},"Atorvastatin\u002Fezetimibe 5\u002F10mg","participants receive Atorvastatin\u002Fezetimibe 5\u002F10mg (Litorvazet 5\u002F10mg)",[53],"Drug: Litorvazet 5\u002F10mg",{"label":55,"type":45,"description":56,"interventionNames":57},"Pitavastatin\u002Fezetimibe 1\u002F10mg","participants receive Pitavastatin\u002Fezetimibe 1\u002F10mg (Baroezet 1\u002F10mg)",[58],"Drug: Baroezet 1\u002F10mg",[60,65,69],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":34},"DRUG","Crezet 2.5\u002F10mg","Participants will take 1 tablet of Rosuvastatin\u002Fezetimibe 2.5\u002F10mg(Crezet 2.5\u002F10mg) orally once daily for 12 months",[44],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":34},"Litorvazet 5\u002F10mg","Participants will take 1 tablet of Atorvastatin\u002Fezetimibe 5\u002F10mg (Litorvazet 5\u002F10mg) orally once daily for 12 months",[50],{"type":61,"name":70,"description":71,"armGroupLabels":72,"otherNames":34},"Baroezet 1\u002F10mg","Participants will take 1 tablet of Pitavastatin\u002Fezetimibe 1\u002F10mg (Baroezet 1\u002F10mg) orally once daily for 12 months",[55],[74],{"name":75,"role":76,"phone":77,"phoneExt":34,"email":78},"Yongcheol Kim, MD,PhD","CONTACT","821058084029","yongcheol@yuhs.ac",[80,94],{"facility":81,"status":34,"city":82,"state":83,"zip":84,"country":85,"countryCode":34,"cosmosGeoPoint":86,"geoPoint":91,"contacts":92},"Yongin Severance Hospital, Yonsei University College of Medicine","Yongin-si","Gyeonggi-do","16995","South Korea",{"type":87,"coordinates":88},"Point",[89,90],127.08042,37.29686,{"lat":90,"lon":89},[93],{"name":75,"role":76,"phone":77,"phoneExt":34,"email":78},{"facility":81,"status":34,"city":82,"state":83,"zip":84,"country":85,"countryCode":34,"cosmosGeoPoint":95,"geoPoint":97,"contacts":34},{"type":87,"coordinates":96},[89,90],{"lat":90,"lon":89},{"type":99,"investigatorFullName":100,"investigatorTitle":101,"investigatorAffiliation":5,"oldNameTitle":34,"oldOrganization":34},"PRINCIPAL_INVESTIGATOR","Yongcheol Kim","Professor (Devision of Cardiology)",[103],{"name":104,"class":105},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY","100659977","phase-4-feasibility-of-combination-therapy-with-low-dose-statin-and-ezetimibe-in-patients-with-minimal-subclinical-atherosclerosis-100659977",false,"NCT07871604","Feasibility of Combination Therapy With Low-dose Statin and Ezetimibe in Patients With Minimal Subclinical Atherosclerosis","MINI-STAR","Inclusion Criteria:\n\n1. Adult men and women between the ages of 30 and 80\n2. Patients with video-confirmed minimal subclinical atherosclerosis who meet one or more of the following criteria:\n\n   * Minimal subclinical coronary artery disease with less than 30% coronary artery stenosis on CCTA or CAG\n   * Individuals with a coronary artery calcification index (CACS\u002FCCS) between 0 and less than 100\n   * Patients with carotid plaque detected on carotid ultrasound (diameter stenosis less than 30%) or intima-media thickness (IMT) of 1.5 mm or more, or a protrusion of 0.5 mm or more\n3. Those eligible for reimbursement for statin\u002Fezetimibe combination therapy at the time of registration, in accordance with the domestic guidelines for dyslipidemia treatment. In other words, the LDL-C reimbursement initiation criteria based on the patient's cardiovascular risk classification\n\n   * Two or more major cardiovascular risk factors, and LDL-C ≥ 130 mg\u002FdL\n   * LDL-C ≥ 160 mg\u002FdL with one major cardiovascular risk factor Registration will proceed only for those who meet the above salary criteria Table. Major Cardiovascular Risk Factors Category Major Cardiovascular Risk Factor Criteria\n\n     1. Age Male ≥ 45 years old, Female ≥ 55 years old\n     2. Family history of early onset of coronary artery disease onset in men at 55 and women at 65\n     3. hypertension If hypertension is present\n     4. Smoker Current Smoker\n     5. Low HDL-C \\\u003C 40mg\u002FdL Deduction: If high HDL-C (protective factor) is ≥ 60 mg\u002FdL, deduct 1 from the number of risk factors\n4. Those who have voluntarily given written consent to participate in this clinical study\n\nExclusion Criteria:\n\n1. Individuals diagnosed with existing diabetes (Type 1 or Type 2 DM): HbA1c ≥ 6.5% or those taking diabetes medications (oral hypoglycemic agents or insulin)\n2. Individuals with a coronary artery calcification index (CACS) of 100 or higher\n3. Individuals with coronary artery stenosis of 30% or more on a CCTA or CAG\n4. Individuals whose LDL-C levels are below the initiation criteria based on the number of major cardiovascular risk factors\n5. Individuals classified as high-risk or ultra-high-risk (For example: acute coronary syndrome or PCI within the past year, or LDL-C target recommended \\\u003C55-70 mg\u002FdL)\n6. Persons with active liver disease or AST\u002FALT levels at or above three times the upper limit of the normal range\n7. Severe chronic renal impairment (eGFR \\\u003C30 mL\u002Fmin\u002F1.73m² or dialysis)\n8. Individuals who are hypersensitive to statins or the ingredient ezetimibe\n9. Pregnant women, nursing women, or women of childbearing age who have difficulty using appropriate contraception","ALL","30 Years","79 Years",{"count":117,"type":118},300,"ESTIMATED","INTERVENTIONAL",[121],"PHASE4","This study aims to compare the tolerability and metabolic safety of three low-dose statin\u002Fezetimibe combinations (rosuvastatin\u002Fezetimibe 2.5\u002F10 mg, atorvastatin\u002Fezetimibe 5\u002F10 mg, pitavastatin\u002Fezetimibe 1\u002F10 mg) in patients with minimal subclinical atherosclerosis identified by imaging studies (CCTA, CAG, or carotid sonography)",[124],"Atherosclerosis Cardiovascular Disease",[126,127],"minimal subclinical atherosclerosis","combination therapy with low-dose statin and ezetimibe","NOT_YET_RECRUITING","2026-10-06",{"date":131,"type":132},"2026-10-13","ACTUAL",{"date":134,"type":118},"2026-11-10",{"date":136,"type":118},"2029-09-21",{"name":5,"class":6},2]