[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100571612":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":25,"centralContacts":30,"locations":36,"responsibleParty":57,"collaborators":25,"id":60,"slug":61,"hasResults":62,"nctId":63,"briefTitle":64,"officialTitle":65,"acronym":25,"eligibilityCriteria":66,"healthyVolunteers":62,"sex":67,"minAge":68,"maxAge":25,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":38,"whyStopped":25,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":92},{"fullName":5,"class":6},"Asan Medical Center","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive lipid-lowering therapy without aspirin","EXPERIMENTAL","In this group, intensive lipid-lowering therapy is performed without aspirin using pitavastatin 4 mg\u002Fezetimibe 10 mg, targeting patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.\n\n◦ Intervention Medications: Pitavastatin 4 mg\u002Fezetimibe 10 mg (aspirin excluded)",[13],"Drug: Pitavastatin 4mg and ezetimibe 10mg, taken once daily",{"label":15,"type":16,"description":17,"interventionNames":18},"Statin Monotherapy with Aspirin","ACTIVE_COMPARATOR","IIn this group, moderate-intensity lipid-lowering therapy is administered using pitavastatin 2 mg and aspirin for patients with coronary artery calcification (Agatston score ≥100) who require primary prevention and do not have physiologically significant coronary artery disease.\n\n◦ Intervention Medications: Pitavastatin 2 mg and aspirin (Based on the clinician's judgment, the statin dosage may be increased to pitavastatin 4 mg depending on the LDL response, and if there are adverse effects associated with aspirin, it can be replaced with clopidogrel.)",[19],"Drug: Pitavastatin 2 mg with aspirin 100 mg, taken once daily.",[21,26],{"type":22,"name":23,"description":9,"armGroupLabels":24,"otherNames":25},"DRUG","Pitavastatin 4mg and ezetimibe 10mg, taken once daily",[9],null,{"type":22,"name":27,"description":28,"armGroupLabels":29,"otherNames":25},"Pitavastatin 2 mg with aspirin 100 mg, taken once daily.","Moderate-intensity lipid-lowering therapy with aspirin",[15],[31],{"name":32,"role":33,"phone":34,"phoneExt":25,"email":35},"Seung-Whan Lee","CONTACT","82230103170","seungwlee@amc.seoul.kr",[37],{"facility":5,"status":38,"city":39,"state":25,"zip":25,"country":40,"countryCode":25,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Seoul","South Korea",{"type":42,"coordinates":43},"Point",[44,45],126.9784,37.566,{"lat":45,"lon":44},[48,50,53,55],{"name":49,"role":33,"phone":25,"phoneExt":25,"email":35},"Seung-Whan Lee, MD",{"name":51,"role":33,"phone":25,"phoneExt":25,"email":52},"Tae Oh Kim, MD","allldie_7@naver.com",{"name":49,"role":54,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"name":51,"role":56,"phone":25,"phoneExt":25,"email":25},"SUB_INVESTIGATOR",{"type":54,"investigatorFullName":58,"investigatorTitle":59,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Seung-Whan Lee, M.D., Ph.D.","Principal Investigator","100571612","phase-4-guide-cac-statin-ezetimibe-without-aspirin-vs-statin-monotherapy-with-aspirin-in-high-coronary-calcification-100571612",false,"NCT06722521","GUIDE-CAC: Statin-Ezetimibe Without Aspirin vs. Statin Monotherapy With Aspirin in High Coronary Calcification","Comparison of Intensive Lipid-Lowering Therapy With a Statin-Ezetimibe Combination (Without Aspirin) vs. Statin Monotherapy (With Aspirin) In Asymptomatic Patient With Coronary Artery Calcification","Inclusion Criteria\n\n1. Adults aged 19 years and older\n2. Asymptomatic patients with significant coronary calcification (Agatston score ≥ 100) and no physiologically significant coronary artery disease (CAD)\n\n   * The coronary CT scan used to establish the CAC score must be performed within 3 years prior to randomization.\n   * The assessment of physiological significance must be performed within 6 months prior to randomization\n3. Participants will be eligible for inclusion regardless of prior statin or anti-platelet agents use.\n\nExclusion Criteria\n\n1. Major ASCVD events (clinically documented ASCVD)\n\n   If at least one of the following criteria is present via patient history, physical examination, or medical records at the time of screening, the patient is not eligible:\n   * Acute coronary syndrome (MI or unstable angina)\n   * Coronary revascularization (PCI, CABG) or other arterial revascularization\n   * Ischemic stroke (Not TIA)\n   * Symptomatic peripheral arterial disease (history of claudication with ABI \\\u003C0.90, or previous revascularization or amputation\n2. Patients with physiologically significant CAD\n\n   * Moderate to severe CAD (diameter stenosis \\>50%) on CCTA with positive strest test (thallium, treadmil, stress echocardiography)\n   * Moderate to severe CAD (diameter stenosis \\>50%) on CAG with positive fractional flow reserve (FFR) \\\u003C 0.8\n3. Patients with familial hypercholesterolemia.\n4. Patients with low-density lipoproteins cholesterol (LDL-C) ≥ 190 mg\u002FdL regardless taking a statin or not.\n5. Continuation of PCSK9 inhibitor is required during the clinical trial\n6. Patients with chronic kidney disease (\\\u003CeGFR 30mL\u002Fmin\u002F1.73m2)\n7. Advanced liver disease (Child-Pugh B or C)\n8. Hepatic disease or biliary tract obstruction, or significant hepatic enzyme elevation (ALT or AST \\> 5 times upper limit of normal).\n9. History of gastrointestinal bleeding, peptic ulcer, or intracranial hemorrhage within 6 months prior screening\n10. Patients with a history of organ transplantation who are on immunosuppressive therapy\n11. Concurrent use of other medications that may increase bleeding risk such NOAC and warfarin\n12. A history of significant allergic reaction to aspirin or statin\u002Fezetimibe\n13. A diagnosis of cancer (other than superficial squamous or basal cell skin cancer) in the past 3 years or current treatment for the active cancer.\n14. Life expectancy \\\u003C 1 years for any non-cardiac or cardiac causes.\n15. Patient's pregnant or breast-feeding or child-bearing potential.\n16. Any clinically significant abnormality identified at the screening visit, physical examination, laboratory tests, or electrocardiogram which, in the judgment of the Investigator, would preclude safe completion of the study.\n17. Unwillingness or inability to comply with the procedures described in this protocol","ALL","19 Years",{"count":70,"type":71},7435,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","A Multicenter, randomized trial comparing the efficacy and safety of intensive lipid-lowering therapy using a statin-ezetimibe combination without aspirin versus statin monotherapy with aspirin in asymptomatic patients with coronary artery calcification",[77,78],"Primary Prevention","Vascular Calcification",[80,81,82],"Cardiovascular Diseases","Aspirin","Statin","2025-08-04",{"date":85,"type":86},"2025-08-07","ACTUAL",{"date":88,"type":86},"2025-07-09",{"date":90,"type":71},"2032-10-31",{"name":5,"class":6},1]