RecruitingNot Applicable

Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

China60 participantsStarted 2023-01-01

Plain-language summary

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

Who can participate

Age range2 Years – 18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Rivaroxaban plasma concentration

Timeframe: From baseline to 6 months after rivaroxaban initiation, with scheduled sampling at the first hospitalization

Rivaroxaban-calibrated anti-activated Factor X (FXa) activity

Timeframe: From baseline to 6 months after rivaroxaban initiation, with anti-FXa activity measured at the same time points as plasma concentration

Trial details

NCT IDNCT06993636

SponsorChildren's Hospital of Fudan University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-12-31

Contact for this trial

Fang Liu, MD

18017590880 liufang@fudan.edu.cn

View on ClinicalTrials.gov More Kawasaki Disease trials