Optimizing Rivaroxaban Dosing for Children with Giant Coronary Aneurysms After Kawasaki Disease
Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study
This study is testing a new way to dose a blood thinner called rivaroxaban for Chinese children with giant coronary aneurysms after Kawasaki disease to see if it helps prevent heart problems.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06978439 on ClinicalTrials.gov |
What this trial studies
This pilot study evaluates a model-informed dosing regimen of rivaroxaban for Chinese children diagnosed with giant coronary artery aneurysms following Kawasaki disease. The study aims to determine the feasibility of a 15 mg-equivalent dose adjusted for age and body weight, based on population pharmacokinetic models. Participants will be monitored for over six months to assess clinical outcomes such as coronary artery thrombosis and major adverse cardiovascular events, while also measuring rivaroxaban levels to validate the dosing model.
Who should consider this trial
Good fit: Ideal candidates include children aged 1 month to under 18 years with confirmed giant coronary artery aneurysms after Kawasaki disease.
Not a fit: Patients with active bleeding risks or a history of venous thromboembolism may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a tailored anticoagulant therapy for children at high risk of cardiovascular events due to Kawasaki disease.
How similar studies have performed: While rivaroxaban has been studied in other pediatric populations, this specific approach for children with giant coronary artery aneurysms after Kawasaki disease is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fang Liu, MD
- Email: liufang@fudan.edu.cn
- Phone: 18017590880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.