Optimizing Rivaroxaban Dosing for Children with Giant Coronary Aneurysms After Kawasaki Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.