About this trial
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed