Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Recruiting now
Conditions studied: Kawasaki Disease, Coronary Artery Aneurysm, Rivaroxaban, Anticoagulant Drugs, Pharmacokinetics and Pharmacodynamics
In brief
Based on an established Kawasaki disease cohort database, this prospective, single-center, single-arm, observational study will collect clinical data from children aged 2 years and older with giant coronary artery aneurysms after Kawasaki disease who received rivaroxaban treatment. Rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms will be measured and analyzed to support the population pharmacokinetic/pharmacodynamic analysis
Key facts
- Study ID
- NCT06993636
- Run by
- Children's Hospital of Fudan University
- People needed
- 60
- Starts
- 2023-01-01
- Expected to finish
- 2026-12-31
- Last updated by the study team
- 2025-05-29
Who can join
Age: 2 and older, up to 18. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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;
- Children aged 2 years to <18 years
You may not qualify if…
- Active bleeding or bleeding risk contraindicating anticoagulant therapy
- Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
- Patients participating in clinical trials of other drugs at the same time
Where it is running
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (enrolling)
Full record on ClinicalTrials.gov
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