[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100592454":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":12,"centralContacts":16,"locations":25,"responsibleParty":44,"collaborators":10,"id":46,"slug":47,"hasResults":48,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":10,"eligibilityCriteria":52,"healthyVolunteers":48,"sex":53,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":10,"studyType":59,"phases":10,"briefSummary":60,"conditions":61,"keywords":66,"overallStatus":27,"whyStopped":10,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Rivaroxaban",null,"Rivaroxaban as anticoagulant will be administered with antiplatelet drug for long-term antithrombotic treatment, following a model-based optimized dosing regimen. Rivaroxaban plasma concentration and rivaroxaban-calibrated Anti-FXa activity are measured for clinical monitoring",[13],{"name":14,"affiliation":5,"role":15},"Fang Liu, MD","STUDY_DIRECTOR",[17,21],{"name":14,"role":18,"phone":19,"phoneExt":10,"email":20},"CONTACT","18017590880","liufang@fudan.edu.cn",{"name":22,"role":18,"phone":23,"phoneExt":10,"email":24},"Guangan Dai, MD","13580762996","gadai24@m.fudan.edu.cn",[26],{"facility":5,"status":27,"city":28,"state":29,"zip":30,"country":31,"countryCode":32,"cosmosGeoPoint":33,"geoPoint":38,"contacts":39},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":34,"coordinates":35},"Point",[36,37],121.45806,31.22222,{"lat":37,"lon":36},[40,42],{"name":41,"role":18,"phone":19,"phoneExt":10,"email":20},"Fang Liu, MD.",{"name":14,"role":43,"phone":10,"phoneExt":10,"email":10},"PRINCIPAL_INVESTIGATOR",{"type":45,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100592454","pharmacometrics-analysis-of-rivaroxaban-in-chinese-children-aged-over-2-years-100592454",false,"NCT06993636","Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years","Population Pharmacokinetic\u002FPharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease","Inclusion Criteria:\n\n1. Giant coronary artery aneurysm(s) in any coronary artery after acute stage of Kawasaki disease. Giant coronary artery aneurysm(s) should be confirmed by two-dimensional echocardiography and meet the diagnostic criteria of Z-score ≥10 or coronary artery internal diameter ≥8mm;\n2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;\n3. Children aged 2 years to \\\u003C18 years\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n3. Patients participating in clinical trials of other drugs at the same time","ALL","2 Years","18 Years",{"count":57,"type":58},60,"ESTIMATED","OBSERVATIONAL","Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic\u002Fpharmacodynamic analysis",[62,63,9,64,65],"Kawasaki Disease","Coronary Artery Aneurysm","Anticoagulant Drugs","Pharmacokinetics and Pharmacodynamics",[67,68,69,70,71],"Kawasaki disease","Coronary artery aneurysm","Population pharmacokinetic and pharmacodynamic","rivaroxaban","anticoagulant","2025-05-25",{"date":74,"type":75},"2025-05-29","ACTUAL",{"date":77,"type":75},"2023-01-01",{"date":79,"type":58},"2026-12-31",{"name":5,"class":6},1]