[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"coronary-artery-aneurysm\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:coronary-artery-aneurysm":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,50,77],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":31,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100591285","phase-4-model-informed-dose-optimization-for-rivaroxaban-in-children-with-giant-coronary-artery-aneurysm-after-kawasaki-disease-100591285",false,"NCT06978439","Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease","Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study","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. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;\n4. Children aged 1 Month to\\\u003C18 years, bodyweight ≥ 2600g.\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.\n3. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n4. An eGFR \\\u003C30 mL\u002Fmin\u002F1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)\n5. Platelet count \\\u003C 100 x 109\u002FL\n6. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \\> 5x ULN or total bilirubin \\> 2x ULN with direct bilirubin \\> 20% of the total\n7. Sustained uncontrolled hypertension defined as systolic and\u002For diastolic blood pressure \\>95 th age percentile\n8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)\n9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine\n10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n11. Inability to cooperate with the study procedures and follow-up visits\n12. Refuse to provide informed consent\n\neGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4","ALL","1 Month","18 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"PHASE4","Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size.\n\nPatients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.",[27,28,29,30],"Kawasaki Disease","Pilot Study","Coronary Artery Aneurysm","Rivaroxaban",[32,33,34,35,36],"kawasaki disease","giant coronary artery aneurysm","rivaroxaban","model-informed dose optimization","anticoagulant","RECRUITING","2025-09-01",{"date":40,"type":41},"2025-09-08","ACTUAL",{"date":43,"type":41},"2024-01-10",{"date":45,"type":21},"2025-12-31",{"name":47,"class":48},"Children's Hospital of Fudan University","OTHER",1,{"id":51,"slug":52,"hasResults":11,"nctId":53,"briefTitle":54,"officialTitle":55,"acronym":56,"eligibilityCriteria":57,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":18,"enrollmentInfo":59,"targetDuration":4,"studyType":22,"phases":61,"briefSummary":62,"conditions":63,"keywords":64,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":69,"lastUpdatePostDateStruct":70,"startDateStruct":72,"completionDateStruct":74,"leadSponsor":76,"locationsCount":49},"100488710","phase-4-rivaroxaban-for-children-aged-over-2-years-with-giant-coronary-artery-aneurysms-after-kawasaki-disease-100488710","NCT05643651","Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease","Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial","RIVA-KG","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 3 months;\n3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;\n4. Children aged ≥ 2 years\n\nExclusion Criteria:\n\n1. Active bleeding or bleeding risk contraindicating anticoagulant therapy\n2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.\n3. Thrombus within giant coronary aneurysm was confirmed by previous imaging examinations, including two-dimensional echocardiography, computed tomography angiography in coronary artery or coronary angiography\n4. An eGFR \\\u003C30mL\u002Fmin\u002F1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)\n5. Platelet count \\\u003C 100 x 109\u002FL\n6. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \\> 5x ULN or total bilirubin \\> 2x ULN with direct bilirubin \\> 20% of the total\n7. Sustained uncontrolled hypertension defined as systolic and\u002For diastolic blood pressure \\>95 th age percentile\n8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)\n9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine\n10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment\n11. Inability to cooperate with the study procedures and follow-up visits\n12. Refuse to provide informed consent eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin; CYP3A4, cytochrome P450 isoenzyme 3A4","2 Years",{"count":60,"type":21},100,[24],"Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years with giant coronary artery aneurysms after Kawasaki disease",[27,29],[65,66,30,67,68],"Kawasaki disease","Giant coronary artery aneurysm","Warfarin","Anticoagulation","2025-06-29",{"date":71,"type":41},"2025-07-02",{"date":73,"type":41},"2025-06-01",{"date":75,"type":21},"2027-09-01",{"name":47,"class":48},{"id":78,"slug":79,"hasResults":11,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":4,"eligibilityCriteria":83,"healthyVolunteers":11,"sex":16,"minAge":58,"maxAge":18,"enrollmentInfo":84,"targetDuration":4,"studyType":86,"phases":4,"briefSummary":87,"conditions":88,"keywords":91,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":94,"lastUpdatePostDateStruct":95,"startDateStruct":97,"completionDateStruct":99,"leadSponsor":101,"locationsCount":49},"100592454","pharmacometrics-analysis-of-rivaroxaban-in-chinese-children-aged-over-2-years-100592454","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",{"count":85,"type":21},60,"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",[27,29,30,89,90],"Anticoagulant Drugs","Pharmacokinetics and Pharmacodynamics",[65,92,93,34,36],"Coronary artery aneurysm","Population pharmacokinetic and pharmacodynamic","2025-05-25",{"date":96,"type":41},"2025-05-29",{"date":98,"type":41},"2023-01-01",{"date":100,"type":21},"2026-12-31",{"name":47,"class":48}]