Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · May 11, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how to best use a medication called Rivaroxaban for children who have giant coronary artery aneurysms after having Kawasaki disease. The trial aims to find out if a specific dose of 15 mg, adjusted based on the child's age and weight, is safe and effective. It will involve monitoring the health of participants for over six months, keeping track of important outcomes like blood clotting in the arteries, major heart-related events, and any bleeding issues.

To be eligible for this study, children aged between 1 month and 17 years who have been diagnosed with a giant coronary artery aneurysm (a serious condition where a blood vessel in the heart is enlarged) may participate. They should also be able to take medications by mouth and not have any serious bleeding risks. If a child joins the study, they will receive the medication and have regular check-ups to monitor their progress. This study will help doctors understand how to better treat children with this specific heart condition.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. 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;
• • 2. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;
• • 3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;
• • 4. Children aged 1 Month to\<18 years, bodyweight ≥ 2600g.
• Exclusion Criteria:
• • 1. Active bleeding or bleeding risk contraindicating anticoagulant therapy
• • 2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.
• • 3. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
• • 4. An eGFR \<30 mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)
• • 5. Platelet count \< 100 x 109/L
• • 6. 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
• • 7. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \>95 th age percentile
• • 8. 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)
• • 9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
• • 10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
• • 11. Inability to cooperate with the study procedures and follow-up visits
• • 12. Refuse to provide informed consent
• • eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4