[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100582456":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":26,"centralContacts":33,"locations":41,"responsibleParty":107,"collaborators":12,"id":109,"slug":110,"hasResults":111,"nctId":112,"briefTitle":113,"officialTitle":113,"acronym":114,"eligibilityCriteria":115,"healthyVolunteers":111,"sex":116,"minAge":117,"maxAge":12,"enrollmentInfo":118,"targetDuration":12,"studyType":121,"phases":122,"briefSummary":124,"conditions":125,"keywords":130,"overallStatus":44,"whyStopped":12,"lastUpdateSubmitDate":135,"lastUpdatePostDateStruct":136,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},{"fullName":5,"class":6},"Second Affiliated Hospital, School of Medicine, Zhejiang University","OTHER",[8,13],{"label":9,"type":10,"description":11,"interventionNames":12},"PCSK9 inhibitors plus background lipid-modifying therapy","EXPERIMENTAL","Patients will receive PCSK9 inhibitors treatment and background lipid-modifying therapy for the first 12 months after randomization, and then continue background lipid-modifying therapy for the remainder of the trial.",null,{"label":14,"type":15,"description":16,"interventionNames":17},"Standard lipid-modifying therapy","ACTIVE_COMPARATOR","Patients will receive standard LMT commonly used in clinical practice.",[18],"Drug: Standard lipid-modifying therapy",[20,24],{"type":21,"name":22,"description":23,"armGroupLabels":12,"otherNames":12},"DRUG","PCSK9 inhibitors and background lipid-modifying therapy","Patients will receive subcutaneous injections of PCSK9 inhibitors and oral administration of background LMT (including statins and\u002For cholesterol absorption inhibitors) for the first 12 months after randomization, with PCSK9 inhibitors administered every 2 weeks. After the first 12 months, patients will discontinue the PCSK9 inhibitors but continue background LMT for the remainder of the trial.",{"type":21,"name":14,"description":16,"armGroupLabels":25,"otherNames":12},[14],[27,30],{"name":28,"affiliation":5,"role":29},"Xinyang Hu","PRINCIPAL_INVESTIGATOR",{"name":31,"affiliation":32,"role":29},"Bon-Kwon Koo","Seoul National University Hospital",[34,38],{"name":28,"role":35,"phone":36,"phoneExt":12,"email":37},"CONTACT","+86 0571 87784808","hxy0507@126.com",{"name":39,"role":35,"phone":36,"phoneExt":12,"email":40},"Jian'an Wang","wangjianan111@zju.edu.cn",[42,58,66,74,82,93],{"facility":43,"status":44,"city":45,"state":46,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":49,"geoPoint":54,"contacts":55},"Zhejiang Provincial Hospital of Traditional Chinese Medicine","RECRUITING","Hangzhou","Zhejiang","China","CN",{"type":50,"coordinates":51},"Point",[52,53],120.16142,30.29365,{"lat":53,"lon":52},[56],{"name":57,"role":35,"phone":12,"phoneExt":12,"email":12},"Maosheng Xu",{"facility":59,"status":44,"city":45,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":60,"geoPoint":62,"contacts":63},"Hangzhou Linping First People's Hospital",{"type":50,"coordinates":61},[52,53],{"lat":53,"lon":52},[64],{"name":65,"role":35,"phone":12,"phoneExt":12,"email":12},"Hong Yuan",{"facility":67,"status":44,"city":45,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"The Second Affiliated Hospital, School of Medicine, Zhejiang University",{"type":50,"coordinates":69},[52,53],{"lat":53,"lon":52},[72,73],{"name":28,"role":35,"phone":36,"phoneExt":12,"email":37},{"name":28,"role":29,"phone":12,"phoneExt":12,"email":12},{"facility":75,"status":44,"city":45,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":76,"geoPoint":78,"contacts":79},"Zhejiang Hospital",{"type":50,"coordinates":77},[52,53],{"lat":53,"lon":52},[80],{"name":81,"role":35,"phone":12,"phoneExt":12,"email":12},"Wei Mao",{"facility":83,"status":44,"city":84,"state":12,"zip":12,"country":47,"countryCode":48,"cosmosGeoPoint":85,"geoPoint":89,"contacts":90},"Jinhua Central Hospital","Jinhua",{"type":50,"coordinates":86},[87,88],119.64421,29.10678,{"lat":88,"lon":87},[91],{"name":92,"role":35,"phone":12,"phoneExt":12,"email":12},"Yibin Pan",{"facility":32,"status":94,"city":95,"state":12,"zip":12,"country":96,"countryCode":12,"cosmosGeoPoint":97,"geoPoint":101,"contacts":102},"NOT_YET_RECRUITING","Seoul","South Korea",{"type":50,"coordinates":98},[99,100],126.9784,37.566,{"lat":100,"lon":99},[103],{"name":104,"role":35,"phone":105,"phoneExt":12,"email":106},"Bon-Kwon Koo, MD","82-2-2072-2062","bkkoo@snu.ac",{"type":108,"investigatorFullName":12,"investigatorTitle":12,"investigatorAffiliation":12,"oldNameTitle":12,"oldOrganization":12},"SPONSOR","100582456","further-lipid-lowering-with-pcsk9-inhibitors-for-cardiovascular-outcomes-in-high-risk-coronary-plaques-assessed-by-ct-angiography-100582456",false,"NCT06863545","Further Lipid-Lowering With PCSK9 Inhibitors for Cardiovascular Outcomes in High-Risk Coronary Plaques Assessed by CT Angiography","FLAVOUR IV","Inclusion Criteria:\n\n1. Subject must be ≥ 18 years.\n2. Patients with at least one target lesion meet CCTA-detected plaque features of the following:\n\n   1. Degree of stenosis ≥ 50% or plaque burden ≥ 70%\n   2. At least 2 of the following high-risk plaque features:\n\n   i. Low-attenuation plaque ii. Positive remodeling iii. Napkin-ring sign iv. Spotty calcium\n3. The target lesion is located at the proximal or mid segment of left anterior descending artery, left circumflex artery or right coronary artery.\n4. Subject is able to confirm his\u002Fher understanding of the risks, benefits, and treatment alternatives of receiving study-related treatment. He\u002Fshe or his\u002Fher legally authorized representative provides written informed consent prior to any study-related procedure.\n\nExclusion Criteria:\n\n1. Target lesions underwent or planned to revascularization.\n2. Patients with acute coronary syndrome.\n3. New York Heart Association class III or IV, or last known left ventricular ejection fraction \\\u003C 30%.\n4. Uncontrolled or recurrent ventricular tachycardia.\n5. Homozygous familial hypercholesterolemia.\n6. Active liver disease or hepatic dysfunction.\n7. Failed CCTA plaque analysis.\n8. Non-cardiac co-morbid conditions with life expectancy \\\u003C 2 years.\n9. Pregnant and\u002For lactating women.\n10. Known hypersensitivity or contraindication to statin or PCSK9 inhibitors.","ALL","18 Years",{"count":119,"type":120},3596,"ESTIMATED","INTERVENTIONAL",[123],"NA","The primary objective was to evaluate the effect of PCSK9 inhibitors in addition to the background lipid-modifying therapy (LMT), compared with standard LMT in terms of clinical outcomes in patients with coronary CT angiography (CCTA)-detected high-risk plaques.",[126,127,128,129],"Coronary Artery Disease","CT Angiography","PCSK9","Cardiovascular Events",[131,132,133,134],"PCSK9 inhibitors","Lipid-lowering therapy","High-Risk Coronary Plaques","Coronary CT angiography","2026-02-03",{"date":137,"type":138},"2026-02-06","ACTUAL",{"date":140,"type":138},"2025-04-22",{"date":142,"type":120},"2033-04",{"name":5,"class":6},6]