Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Fudan University

Status: Enrolling

Conditions: Pharmacokinetics and Pharmacodynamics; Rivaroxaban; Coronary Artery Aneurysm; Kawasaki Disease; Anticoagulant Drugs

Study type: Observational

Funder types: Other

Identifiers

NCT06993636

RIVA-KD-PopPK

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: All

Ages: 2 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

60 participants in 1 patient group

Rivaroxaban

Description:

Rivaroxaban as anticoagulant will be administered with antiplatelet drug for long-term antithrombotic treatment, following a model-based optimized dosing regimen. Rivaroxaban plasma concentration and rivaroxaban-calibrated Anti-FXa activity are measured for clinical monitoring