[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100488710":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":41,"centralContacts":45,"locations":55,"responsibleParty":74,"collaborators":49,"id":76,"slug":77,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":86,"enrollmentInfo":87,"targetDuration":49,"studyType":90,"phases":91,"briefSummary":93,"conditions":94,"keywords":97,"overallStatus":57,"whyStopped":49,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Children's Hospital of Fudan University","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Rivaroxaban+Antiplatelet drug","EXPERIMENTAL","Rivaroxaban as anticoagulant will be administered with antiplatelet drug for 3 months. Antiplatelet drug can choose Aspirin or Clopidogrel depending on participant medical history and physician's recommendation.",[13,14],"Drug: Rivaroxaban Oral Tablet [Xarelto]","Drug: Aspirin or Clopidogrel",{"label":16,"type":17,"description":18,"interventionNames":19},"Standard antithrombotic care","ACTIVE_COMPARATOR","Warfarin as anticoagulant will be administered with antiplatelet drug for 3 months. Antiplatelet drug can choose Aspirin or Clopidogrel depending on participant medical history and physician's recommendation. International normalized ratio(INR) should be tested once a month and maintained in target range(1.5\\~2.5).\n\n2.Aspirin\\[3 \\~5mg\u002F(kg·d), once daily\\] or Clopidogrel\\[ 1.0 mg\u002Fkg; once daily\\] according to experienced clinician recommendation and individual condition.",[14,20],"Drug: Warfarin",[22,29,35],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Rivaroxaban Oral Tablet [Xarelto]","Administered in an age- and bodyweight-adjusted, 15 mg-equivalent dose regimen proposed by model- and clinical evidence-informed precision dosing",[9],[28],"Xarelto",{"type":23,"name":30,"description":31,"armGroupLabels":32,"otherNames":33},"Aspirin or Clopidogrel","Aspirin \\[3 \\~5mg\u002F(kg·d) once daily\\] or Clopidogrel \\[1.0 mg\u002Fkg; once daily\\]",[9,16],[34],"Antiplatelet therapy",{"type":23,"name":36,"description":37,"armGroupLabels":38,"otherNames":39},"Warfarin","Warfarin 0.05\\~0.12 mg\u002F(kg·d) once daily. INR should maintain within 1.5 to 2.5",[16],[40],"Vitamin K Antagonist",[42],{"name":43,"affiliation":5,"role":44},"Fang Liu, MD","STUDY_DIRECTOR",[46,51],{"name":43,"role":47,"phone":48,"phoneExt":49,"email":50},"CONTACT","18017590880",null,"liufang@fudan.edu.cn",{"name":52,"role":47,"phone":53,"phoneExt":49,"email":54},"Guangan Dai","13580762996","gadai24@m.fudan.edu.cn",[56],{"facility":5,"status":57,"city":58,"state":59,"zip":60,"country":61,"countryCode":62,"cosmosGeoPoint":63,"geoPoint":68,"contacts":69},"RECRUITING","Shanghai","Shanghai Municipality","201102","China","CN",{"type":64,"coordinates":65},"Point",[66,67],121.45806,31.22222,{"lat":67,"lon":66},[70,72],{"name":71,"role":47,"phone":49,"phoneExt":49,"email":49},"Fang Liu, MD.",{"name":43,"role":73,"phone":49,"phoneExt":49,"email":49},"PRINCIPAL_INVESTIGATOR",{"type":75,"investigatorFullName":49,"investigatorTitle":49,"investigatorAffiliation":49,"oldNameTitle":49,"oldOrganization":49},"SPONSOR","100488710","phase-4-rivaroxaban-for-children-aged-over-2-years-with-giant-coronary-artery-aneurysms-after-kawasaki-disease-100488710",false,"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","ALL","2 Years","18 Years",{"count":88,"type":89},100,"ESTIMATED","INTERVENTIONAL",[92],"PHASE4","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",[95,96],"Kawasaki Disease","Coronary Artery Aneurysm",[98,99,100,36,101],"Kawasaki disease","Giant coronary artery aneurysm","Rivaroxaban","Anticoagulation","2025-06-29",{"date":104,"type":105},"2025-07-02","ACTUAL",{"date":107,"type":105},"2025-06-01",{"date":109,"type":89},"2027-09-01",{"name":5,"class":6},1]