[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572860":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":10,"centralContacts":38,"locations":44,"responsibleParty":61,"collaborators":10,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":71,"eligibilityCriteria":72,"healthyVolunteers":67,"sex":73,"minAge":74,"maxAge":10,"enrollmentInfo":75,"targetDuration":78,"studyType":79,"phases":10,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":46,"whyStopped":10,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Chinese PLA General Hospital","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Intensive treatment group",null,"patients were treated with PCSK9 inhibitors (with or without statins ± Ezetimibe\u002FHybutimibe)",[13],"Drug: PCSK9 inhibitor",{"label":15,"type":10,"description":16,"interventionNames":17},"Conventional combination therapy group","patients were treated with statin＋Ezetimibe\u002FHybutimibe",[18],"Drug: Statin+Ezetimibe\u002FHybutimibe compound",{"label":20,"type":10,"description":21,"interventionNames":22},"control group","patients were treated with statin only",[23],"Drug: Statin",[25,30,34],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":10},"DRUG","PCSK9 inhibitor","The patient used PCSK9 inhibitor (with or without statins ± Ezetimibe\u002FHybutimibe) in the early hospitalization, and patients continually prescribed or stopped PCSK9 inhibitors treatment during the follow-up visit, which depend on physician's clinical decision and patient preference. PCSK9 inhibitors include Evolocumab, Alirocumab, Tafolecimab, Recaticimab, and Inclisiran, among others.",[9],{"type":26,"name":31,"description":32,"armGroupLabels":33,"otherNames":10},"Statin+Ezetimibe\u002FHybutimibe compound","The patient used statins and Ezetimibe\u002FHybutimibe in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.",[15],{"type":26,"name":35,"description":36,"armGroupLabels":37,"otherNames":10},"Statin","The patient used statins in early hospitalization, and then once a day for 12 months. Whether to adjust the lipid-lowering regimen during follow-up depends on physician's clinical decision and patient preference.",[20],[39],{"name":40,"role":41,"phone":42,"phoneExt":10,"email":43},"Dandan Li, professor","CONTACT","8613810545564","lidandan5564@163.com",[45],{"facility":5,"status":46,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"RECRUITING","Beijing","Beijing Municipality","100853","China","CN",{"type":53,"coordinates":54},"Point",[55,56],116.39723,39.9075,{"lat":56,"lon":55},[59],{"name":60,"role":41,"phone":42,"phoneExt":10,"email":43},"Dandan Li",{"type":62,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"SPONSOR_INVESTIGATOR","Yun Dai Chen","professor","100572860","multicenter-real-world-cohort-study-evaluating-the-impact-of-early-intensive-lipid-lowering-therapy-on-the-prognosis-of-acute-coronary-syndrome-patientselite-acs-100572860",false,"NCT06738758","Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients(ELITE-ACS)","Multicenter Real-World Cohort Study Evaluating the Impact of Early Intensive Lipid-Lowering Therapy on the Prognosis of Acute Coronary Syndrome Patients","ELITE-ACS","Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. This hospitalization for ACS, which includes ST-segment elevation MI (STEMI), non-ST-segment elevation MI (NSTEMI), or unstable angina pectoris (UA) with a GRACE score of intermediate to high risk.\n3. Written informed consent must be obtained from eligible patients prior to study enrollment.\n4. LDL-C ≥1.8 mmol\u002FL in patients using statin; LDL-C ≥2.6 mmol\u002FL in those not taking statin in the last 4 weeks.\n\nExclusion Criteria:\n\n1. Received PCSK9 inhibitor therapy within 3 months.\n2. Patient has any life-threatening severe disease, including severe liver injury and persistent elevation of serum transaminases, and severe renal failure.\n3. Patient has a history of renal or cardiac transplantation.\n4. The patient is a pregnant or breastfeeding woman or a woman planning to become pregnant.\n\nPatients judged by the investigator to be unsuitable for enrollment.","ALL","18 Years",{"count":76,"type":77},6000,"ESTIMATED","1 Year","OBSERVATIONAL","The purpose of this clinical trial is to evaluate the impact of early initiation of PCSK9 inhibitor therapy for intensive lipid-lowering in Chinese patients with acute coronary syndrome (ACS) during hospitalization on the rate of lipid goal attainment, the time to achieve guideline-recommended lipid levels within one year, and the incidence of adverse cardiovascular events.\n\nThe primary research question is whether early initiation of PCSK9 inhibitor therapy during hospitalization for ACS patients in a real-world Chinese setting can increase the rate of lipid goal attainment, shorten the time to reach guideline-recommended lipid levels within one year, and improve the risk of adverse cardiovascular events.\n\nResearchers will compare three lipid-lowering strategies: PCSK9 inhibitor therapy (with or without statins ± Ezetimibe\u002FHybutimibe), statin plus Ezetimibe\u002FHybutimibe therapy, and statin monotherapy, to assess the potential of PCSK9 inhibitor drugs in accelerating lipid goal achievement and reducing adverse cardiovascular events in ACS patients.\n\nParticipants will:\n\nReceive PCSK9 inhibitor therapy (with or without daily statins ± Ezetimibe\u002FHybutimibe) every two weeks, or daily statin plus Ezetimibe\u002FHybutimibe therapy, or daily statin monotherapy.\n\nUndergo follow-up assessments of relevant laboratory indicators at baseline, 3 days after admission, discharge, and 1, 3, 6, and 12 months post-discharge.\n\nRecord the occurrence of major adverse cardiovascular events.",[82],"Acute Coronary Syndromes",[82,84,85,86],"PCSK9 Inhibitor","Lipid compliance time and rate","First cardiovascular event","2025-03-13",{"date":89,"type":90},"2025-03-17","ACTUAL",{"date":92,"type":90},"2024-12-16",{"date":94,"type":77},"2027-12-31",{"name":63,"class":6},1]