Status:
RECRUITING
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Kawasaki Disease
Pilot Study
Eligibility:
All Genders
1-18 years
Phase:
PHASE4
Brief Summary
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 af...
Detailed Description
Giant coronary artery aneurysm (GCAA) is a rare but severe cardiac complication of Kawasaki disease (KD). Due to the abnormal blood rheology and the hyper-inflammatory response accompanied by thromboc...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 10 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06978439
Start Date
January 10 2024
End Date
December 31 2025
Last Update
September 8 2025
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102