[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100640955":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":31,"locations":37,"responsibleParty":53,"collaborators":26,"id":57,"slug":58,"hasResults":59,"nctId":60,"briefTitle":61,"officialTitle":62,"acronym":63,"eligibilityCriteria":64,"healthyVolunteers":59,"sex":65,"minAge":66,"maxAge":67,"enrollmentInfo":68,"targetDuration":26,"studyType":71,"phases":72,"briefSummary":74,"conditions":75,"keywords":77,"overallStatus":79,"whyStopped":26,"lastUpdateSubmitDate":80,"lastUpdatePostDateStruct":81,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":89},{"fullName":5,"class":6},"Beijing Anzhen Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Ultra-low LDL-C target group","EXPERIMENTAL","Participants receive statin-ezetimibe-based lipid-lowering therapy with mandatory titration algorithm, adding PCSK9 inhibitor sequentially to achieve LDL-C \\\u003C1.0 mmol\u002FL.",[13],"Drug: Lipid-lowering therapy targeting LDL-C \u003C1.0 mmol\u002FL",{"label":15,"type":16,"description":17,"interventionNames":18},"Moderate-low LDL-C target group","ACTIVE_COMPARATOR","Participants maintain statin-ezetimibe therapy; dose reduction is enforced if LDL-C \\\u003C1.0 mmol\u002FL to keep level within 1.0-1.39 mmol\u002FL.",[19],"Drug: Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol\u002FL",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Lipid-lowering therapy targeting LDL-C \u003C1.0 mmol\u002FL","Statin-ezetimibe-based lipid-lowering therapy with mandatory titration-maintenance-off-target correction algorithm. PCSK9 inhibitor is sequentially added and dose-adjusted based on centralized blinded lipid test results to achieve LDL-C level \\\u003C1.0 mmol\u002FL.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"Lipid-lowering therapy targeting LDL-C 1.0-1.39 mmol\u002FL","Standard statin-ezetimibe lipid-lowering therapy. Mandatory dose reduction (discontinue ezetimibe → halve statin → discontinue statin) will be performed if LDL-C drops below 1.0 mmol\u002FL, to maintain LDL-C within 1.0-1.39 mmol\u002FL.",[15],[32],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},"Hai Gao, MD","CONTACT","+86 13901015971","gaohai1221@mail.ccmu.edu.cn",[38],{"facility":39,"status":26,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":51},"Beijing Anzhen Hospital, Capital Medical University","Beijing","Beijing Municipality","100029","China","CN",{"type":46,"coordinates":47},"Point",[48,49],116.39723,39.9075,{"lat":49,"lon":48},[52],{"name":33,"role":34,"phone":35,"phoneExt":26,"email":36},{"type":54,"investigatorFullName":55,"investigatorTitle":56,"investigatorAffiliation":5,"oldNameTitle":26,"oldOrganization":26},"PRINCIPAL_INVESTIGATOR","Hai Gao","Chief Physician","100640955","target-oriented-strategy-of-ultra-low-ldl-c-10-vs-10-139-mmoll-in-extreme-high-risk-ascvd-patients-clinical-benefit-safety-and-cost-effectiveness-assessment-100640955",false,"NCT07615296","Target-Oriented Strategy of Ultra-Low LDL-C (\u003C1.0 vs. 1.0-1.39 mmol\u002FL) in Extreme-High-Risk ASCVD Patients: Clinical Benefit, Safety and Cost-Effectiveness Assessment","Target-Oriented Strategy of Ultra-Low LDL-C Goal in Extreme-High-Risk ASCVD Patients (\u003C1.0 vs. 1.0-1.39 mmol\u002FL): Clinical Benefit, Safety and Cost-Effectiveness Assessment- A Multicenter, Prospective, Randomized, Open-Label, Blinded-Endpoint Adaptive Trial","TARGET-EXTREME","Inclusion Criteria:\n\n1. Aged 18-80 years, any sex.\n2. Diagnosed with ultra-high-risk ASCVD per 2023 Chinese Lipid Guidelines: either ≥2 major ASCVD events within 24 months, or 1 major ASCVD event plus ≥2 high-risk factors (diabetes, multi-vessel disease, premature CHD family history, elevated Lp(a), hypertension).\n3. LDL-C ≥1.0 mmol\u002FL after ≥4-week maximum-tolerated statin plus ezetimibe therapy, confirmed by central laboratory.\n4. Able to complete follow-up and examinations; no severe hepatic\u002Frenal dysfunction.\n5. Voluntary participation with written informed consent.\n\nExclusion Criteria:\n\n1. Hypersensitivity or intolerance to statins, ezetimibe, or PCSK9 inhibitors.\n2. Hemorrhagic stroke, active bleeding, severe trauma or major surgery within 6 months before enrollment.\n3. Malignancy (expected survival \\\u003C3 years), severe liver\u002Fkidney disease, or autoimmune disease.\n4. Cognitive impairment (MoCA \\\u003C20) or psychiatric disorders precluding assessment cooperation.\n5. Pregnant, breastfeeding, or planning pregnancy during the trial.\n6. Participation in other clinical trials or use of other lipid-lowering drugs within 3 months.\n7. Poor compliance or other conditions judged by investigators to interfere with the study.","ALL","18 Years","80 Years",{"count":69,"type":70},6000,"ESTIMATED","INTERVENTIONAL",[73],"NA","The goal of this clinical trial is to learn whether an ultra-low LDL-C target (\\\u003C1.0 mmol\u002FL) can improve clinical outcomes compared with a moderately low LDL-C target (1.0-1.39 mmol\u002FL) in Chinese patients with extreme-high-risk atherosclerotic cardiovascular disease (ASCVD). It also aims to evaluate long-term safety and cost-effectiveness, and explore potential benefit subgroups and underlying mechanisms. The main questions it aims to answer are:\n\nDoes an LDL-C target \\\u003C1.0 mmol\u002FL reduce major adverse cardiovascular events (MACE-4: cardiovascular death, non-fatal myocardial infarction, non-fatal ischemic stroke, urgent coronary revascularization) compared with a target of 1.0-1.39 mmol\u002FL?What are the long-term safety risks including cognitive decline, hemorrhagic stroke, new-onset diabetes, new malignancies and severe adverse drug reactions under different LDL-C targets?Researchers will compare participants receiving an LDL-C target \\\u003C1.0 mmol\u002FL with those receiving a target of 1.0-1.39 mmol\u002FL to see if the ultra-low LDL-C strategy provides better clinical benefit with acceptable safety and economic value.\n\nParticipants will:\n\nReceive lipid-lowering therapy following a mandatory titration-maintenance-off-target correction algorithm according to their assigned LDL-C target Undergo routine follow-up every 3 months, cognitive assessment every 6 months, and comprehensive annual re-examinations for a median of 2 years and up to 5 years Have centralized blinded lipid testing and endpoint adjudication by an independent Clinical Event Committee",[76],"Atherosclerotic Cardiovascular Disease (ASCVD)",[78],"Extreme-high-risk ASCVD, LDL-C target, Ultra-low LDL-C, Lipid-lowering therapy","NOT_YET_RECRUITING","2026-05-23",{"date":82,"type":83},"2026-05-29","ACTUAL",{"date":85,"type":70},"2027-01-01",{"date":87,"type":70},"2031-12-31",{"name":5,"class":6},1]