[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"rivaroxaban\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:rivaroxaban":30},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,50,80,107],{"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":54,"acronym":55,"eligibilityCriteria":56,"healthyVolunteers":11,"sex":57,"minAge":18,"maxAge":4,"enrollmentInfo":58,"targetDuration":4,"studyType":22,"phases":59,"briefSummary":61,"conditions":62,"keywords":68,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":74,"completionDateStruct":76,"leadSponsor":78,"locationsCount":49},"100579990","phase-1-excretion-of-rivaroxaban-in-human-breast-milk-100579990","NCT06831474","Excretion of Rivaroxaban in Human Breast Milk","LACT","Inclusion Criteria:\n\n1. Postpartum within 6 weeks of delivery\n2. Greater than 18 years old at expected date of delivery\n3. English speaking\n4. Hemodynamically stable without concern for ongoing blood loss\n5. Non-breastfeeding\n6. Or breastfeeding an infant born at or equal to 37 weeks' gestation, weighing \\>2600g at birth and is not requiring intensive care\n7. Meet inclusion criteria for prophylactic rivaroxaban dose: pre-pregnancy BMI \\>\u002F= 40 and\u002For any personal history of VTE. Or \\>\u002F= 2 of the following: pre-pregnancy BMI 30-39, immobility, pregnancy complications, cesarean delivery, hysterectomy\n8. Or meet inclusion criteria for therapeutic rivaroxaban dose: have an indication for therapeutic anticoagulation per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196, or other indication per their primary team, and recommended for such anticoagulation per their primary practitioner.\n\nExclusion Criteria:\n\n1. Pregnant\n2. Less than 18 years old at estimated date of delivery\n3. Hemodynamic instability and\u002For concern for ongoing blood loss\n4. Newly diagnosed deep vein thrombosis (DVT) or pulmonary embolism (PE) in the postpartum period\n5. Abnormal maternal renal or liver function (creatinine clearance \\\u003C 30 mL\u002Fmin and\u002For liver function tests greater than lab normal)\n6. A contraindication to rivaroxaban: hypersensitivity to rivaroxaban; active pathological bleeding\n7. Breastfeeding an infant admitted to neonatal intensive care unit, infant gestational age at birth \\\u003C37w0d or weighing \\\u003C2600g.\n8. If all of the following are met: age less than 40, ambulating, body mass index (BMI) less than 30, no active history of malignancy.\n9. If patient lacks indication for therapeutic anticoagulation in the postpartum period per the American College of Obstetricians and Gynecologists' (ACOG) practice bulletin #196","FEMALE",{"count":20,"type":21},[60],"PHASE1","The purpose of this study is to investigate the distribution of rivaroxaban into human milk at both therapeutic and prophylactic doses, and over time with repeated dosing.",[63,64,65,30,66,67],"Postpartum","VTE Prophylaxis","VTE (Venous Thromboembolism)","Breastfeeding","Breast Milk Collection",[30,69,55,70],"Relative infant dose","Rivaroxaban in breast milk","2025-07-14",{"date":73,"type":41},"2025-07-17",{"date":75,"type":21},"2025-07",{"date":77,"type":21},"2026-07-31",{"name":79,"class":48},"Thomas Jefferson University",{"id":81,"slug":82,"hasResults":11,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":4,"eligibilityCriteria":86,"healthyVolunteers":11,"sex":16,"minAge":87,"maxAge":18,"enrollmentInfo":88,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":91,"conditions":92,"keywords":95,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":99,"lastUpdatePostDateStruct":100,"startDateStruct":102,"completionDateStruct":104,"leadSponsor":106,"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","2 Years",{"count":89,"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",[27,29,30,93,94],"Anticoagulant Drugs","Pharmacokinetics and Pharmacodynamics",[96,97,98,34,36],"Kawasaki disease","Coronary artery aneurysm","Population pharmacokinetic and pharmacodynamic","2025-05-25",{"date":101,"type":41},"2025-05-29",{"date":103,"type":41},"2023-01-01",{"date":105,"type":21},"2026-12-31",{"name":47,"class":48},{"id":108,"slug":109,"hasResults":11,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":4,"eligibilityCriteria":113,"healthyVolunteers":11,"sex":16,"minAge":18,"maxAge":4,"enrollmentInfo":114,"targetDuration":4,"studyType":90,"phases":4,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":129,"whyStopped":4,"lastUpdateSubmitDate":130,"lastUpdatePostDateStruct":131,"startDateStruct":133,"completionDateStruct":135,"leadSponsor":137,"locationsCount":139},"100497984","imapct-of-biomarkers-on-pharmacodynamics-and-bleeding-risk-of-direct-oral-anticoagulants-and-ticagrelor-study-ii-100497984","NCT05764356","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II","Imapct of bioMarkers on Pharmacodynamics and Bleeding Risk of Direct Oral AntiCoagulants and Ticagrelor Study II (IMPACT 2)","Inclusion Criteria:\n\n(I) Chinese Patients taking NOACs\n\n* In accordance with anticoagulation indications of NOACs, include prevention of thrombosis in non valvular atrial fibrillation, prevention and treatment of deep vein thrombosis \u002F pulmonary embolism and prevention of thrombosis after knee \u002F hip replacement;\n* More than 18 years of age, male or female;\n* Never received NOACs in a month and intend to take NOACs or have received NOACs for more than one week continuously;\n* sign informed consent.\n\n(II) Chinese Patients taking ticagrelor\n\n* With diagnosis of acute coronary syndrome (ACS), included unstable angina, non ST segment elevation myocardial infarction and ST segment elevation myocardial infarction;\n* More than 18 years of age, male or female;\n* Never received ticagrelor in a month and intend to take ticagrelor or have received ticagrelor for more than one week continuously#\n* sign informed consent.\n\nExclusion Criteria:\n\n* With history of immunodeficiency disease, including positive HIV index;\n* Positive Hepatitis B surface antigen (HBsAg) and HCV index;\n* Combined therapy of CYP3A4 strong inhibitors and P-gp inhibitors (e.g., systemic pyrrole antifungal agents such as ketoconazole, itraconazole, voriconazole and posaconazole; human immunodeficiency virus (HIV) - protease inhibitors such as ritonavir), CYP3A4 strong inducers and P-gp inducers (e.g., rifampicin, phenytoin, phenobarbital, carbamazepine, St. John's Wort, etc.) in 14 days before treatment with NOACs;\n* Severe liver dysfunction and abnormal renal function;\n* Include contraindications of antithrombosis, such as hypersensitivity, active bleeding, moderate or severe liver disease, previous history of intracranial hemorrhage, gastrointestinal hemorrhage in the past 6 months and major operation within 30 days.",{"count":115,"type":21},2000,"Individual differences in drug efficacy and adverse reactions are common in the clinical application of drugs. Individual differences are caused by many factors, among which genetic factors account for more than 20%. Novel oral anticoagulant drugs (NOACs, including rivaroxaban, apixaban, edoxaban, dabigatran, etc.) and novel antiplatelet drug ticagrelor have the advantages of convenient use and no need for monitoring. But novel oral antithrombotic drugs also increase the risk of bleeding, and there is currently a lack of effective antagonists when antithrombosis is excessive or emergency surgery is required. At present, there are few studies on the causes of individual differences in novel antithrombotic drugs, and there is a lack of predictable biomarkers or drug genotypes, especially in China. Therefore, on the basis of previous studies on NOACs and ticagrelor individualized medication cohorts, this study plans to establish a validation cohort for novel antithrombotic drugs bleeding related biomarkers, conduct multi-omics testing and long-term follow-up, and explore markers related to pharmacodynamics of antithrombotic drugs, adverse bleeding reactions and clinical outcomes.",[118,119,30,120,121,122,123,124,125,126,127,128],"Novel Oral Anticoagulants","NOACs","Apixaban","Edoxaban","Dabigatran","Ticagrelor","Pharmacodynamics","Pharmacogenomics","RNA Profile","Bleeding","Biomarker","NOT_YET_RECRUITING","2023-03-01",{"date":132,"type":41},"2023-03-10",{"date":134,"type":21},"2023-03",{"date":136,"type":21},"2027-12",{"name":138,"class":48},"Peking University First Hospital",6]