[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100556116":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":40,"responsibleParty":56,"collaborators":25,"id":59,"slug":60,"hasResults":61,"nctId":62,"briefTitle":63,"officialTitle":64,"acronym":25,"eligibilityCriteria":65,"healthyVolunteers":61,"sex":66,"minAge":67,"maxAge":68,"enrollmentInfo":69,"targetDuration":25,"studyType":72,"phases":73,"briefSummary":75,"conditions":76,"keywords":79,"overallStatus":42,"whyStopped":25,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":91},{"fullName":5,"class":6},"First Affiliated Hospital of Xinjiang Medical University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"PCSK9 inhibitor group","EXPERIMENTAL","PCSK9 Inhibitors Combined with Moderate-Intensity Statin Therapy",[13],"Drug: PCSK9 inhibitor",{"label":15,"type":6,"description":16,"interventionNames":17},"Intensive statin group","Intensive statin therapy",[18],"Drug: Statin",[20,26],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","PCSK9 inhibitor","PCSK9 inhibitors combined with moderate-intensity statin therapy",[9],null,{"type":21,"name":27,"description":16,"armGroupLabels":28,"otherNames":25},"Statin",[15],[30],{"name":31,"affiliation":5,"role":32},"Zhenyan Fu, PhD","PRINCIPAL_INVESTIGATOR",[34],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},"Sen Liu, MD","CONTACT","09914366872","+86","463387160@qq.com",[41],{"facility":5,"status":42,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"RECRUITING","Ürümqi","Xinjiang","830011","China","CN",{"type":49,"coordinates":50},"Point",[51,52],87.60046,43.80096,{"lat":52,"lon":51},[55],{"name":35,"role":36,"phone":37,"phoneExt":38,"email":39},{"type":32,"investigatorFullName":57,"investigatorTitle":58,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"Zhenyan Fu, PHD","Principle Investigator","100556116","phase-4-effect-of-pcsk9-inhibitors-on-coronary-atherosclerotic-plaques-derived-from-optical-coherence-tomography-100556116",false,"NCT06520904","Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography","Effect of PCSK9 Inhibitors on Coronary Atherosclerotic Plaques Derived From Optical Coherence Tomography in Patients With Premature Coronary Artery Disease: a Randomized Controlled Trial","Inclusion Criteria:\n\n* Men aged 18-55 years and women aged 18-65 years;\n* CAD patients with coronary angiographically confirmed lesions in ≥2 vessels; at least one vessel was critically diseased (50-70% stenosis level);\n* LDL-C \\>3.4 mmol\u002FL without regular statin therapy or LDL-C \\>1.8 mmol\u002FL after 4 weeks of statin lipid-lowering therapy.\n\nExclusion Criteria:\n\n* Known allergies or contraindications to PCSK9 inhibitors and\u002For statin therapy;\n* Prior use of PCSK9 inhibitors;\n* Prior history of hemorrhagic stroke;\n* Prior coronary artery bypass grafting or coronary intervention;\n* Inability to perform OCT imaging or unclear imaging;\n* Severe renal insufficiency (creatinine clearance \\\u003C 30 mL\u002Fmin);\n* Severe hepatic dysfunction;\n* Baseline triglycerides \\> 5.6 mmol\u002FL;\n* Pregnant or lactating women;\n* Life expectancy not exceeding 1 year;\n* In the judgment of the investigator, unsuitable for this study for any reason.","ALL","18 Years","65 Years",{"count":70,"type":71},396,"ESTIMATED","INTERVENTIONAL",[74],"PHASE4","The presence of coronary atherosclerotic vulnerable plaque significantly impacts the clinical outcomes of patients diagnosed with coronary artery disease (CAD). However, the influence of PCSK9 inhibitors on stabilizing coronary atherosclerotic plaques in individuals with early-onset CAD, evaluated through optical coherence tomography (OCT), remains inadequately understood. Moreover, there is a notable absence of relevant randomized controlled trials investigating this phenomenon. This current study represents a single-center, randomized, controlled, open-label trial conducted among Asian patients with early-onset CAD. Its principal objective was to explore the effects of PCSK9 inhibitors on coronary atherosclerotic plaque morphology as assessed by OCT.",[77,78],"Coronary Artery Disease","Optical Coherence Tomography",[77,80,81,78],"Lipid-lowering Therapy","PCSK9","2024-08-16",{"date":84,"type":85},"2024-08-19","ACTUAL",{"date":87,"type":85},"2024-07-01",{"date":89,"type":71},"2026-12-31",{"name":5,"class":6},1]