Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · May 25, 2025

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called rivaroxaban in children aged 2 years and older who have had Kawasaki disease and now have giant coronary artery aneurysms. Kawasaki disease can cause inflammation in the blood vessels and lead to serious heart problems, so this study aims to better understand how rivaroxaban, an anticoagulant (a drug that helps prevent blood clots), works in these young patients. Researchers will collect important health information and blood samples to see how the drug affects the children’s blood and how their bodies process the medication.

To be eligible for the trial, children need to have confirmed giant coronary artery aneurysms, which are large bulges in the blood vessels of the heart. They must also be receiving anticoagulant therapy for the next six months. However, children with active bleeding conditions or those who are sensitive to the medication cannot participate. If eligible, participants can expect to have their health monitored closely, including regular blood tests to measure how well the medication is working. This study is actively recruiting participants, and it hopes to provide valuable insights into how to treat children with these serious heart complications safely and effectively.

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. Children aged 2 years to \<18 years
• Exclusion Criteria:
• • 1. Active bleeding or bleeding risk contraindicating anticoagulant therapy
• • 2. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
• • 3. Patients participating in clinical trials of other drugs at the same time