Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Kawasaki Disease, Coronary Artery Aneurysm, Rivaroxaban, Anticoagulant Drugs. Basic parameters: 2 years — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Overview
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
Primary outcome measures
- Rivaroxaban plasma concentration [Time frame: From baseline to 6 months after rivaroxaban initiation, with scheduled sampling at the first hospitalization]
- Rivaroxaban-calibrated anti-activated Factor X (FXa) activity [Time frame: From baseline to 6 months after rivaroxaban initiation, with anti-FXa activity measured at the same time points as plasma concentration]
Secondary outcome measures (2)
- Occurrence of new thrombosis in coronary arteries [Time frame: From baseline to 6 months after rivaroxaban initiation]
- Composite of Major bleeding or Clinically relevant non-major bleeding event [Time frame: From baseline to 6 months after rivaroxaban initiation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- Children's Hospital of Fudan University — Shanghai
Identifiers
NCT: NCT06993636 · RIVA-KD-PopPK