Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-18
SponsorChildren's Hospital of Fudan University

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

Trial groups

60 Participants
are grouped into 1 trial group