Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Recruiting now · Phase 4
Conditions studied: Kawasaki Disease, Pilot Study, Coronary Artery Aneurysm, Rivaroxaban
In brief
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. Patients 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.
Key facts
- Study ID
- NCT06978439
- Run by
- Children's Hospital of Fudan University
- People needed
- 10
- Starts
- 2024-01-10
- Expected to finish
- 2025-12-31
- Last updated by the study team
- 2025-09-08
Who can join
Age: 0 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;
- Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;
- Children aged 1 Month to<18 years, bodyweight ≥ 2600g.
You may not qualify if…
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.
- Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
- An eGFR <30 mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)
- Platelet count < 100 x 109/L
- 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
- Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure >95 th age percentile
- 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)
- Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
- Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
- Inability to cooperate with the study procedures and follow-up visits
- Refuse to provide informed consent
- eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4
Where it is running
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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