Analyzing Rivaroxaban in Chinese Children with Kawasaki Disease
Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Children's Hospital of Fudan University · NCT06993636
This study is testing how well the blood thinner rivaroxaban works in children with Kawasaki disease who have serious heart problems.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University (other) |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06993636 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical data from children aged 2 years and older who have giant coronary artery aneurysms resulting from Kawasaki disease and are receiving treatment with rivaroxaban. The study will utilize an established Kawasaki disease cohort database to measure rivaroxaban plasma concentrations, anti-factor Xa activity levels, and genetic polymorphisms. The goal is to perform a population pharmacokinetic and pharmacodynamic analysis to better understand the drug's effects in this specific pediatric population.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 2 to 18 years with confirmed giant coronary artery aneurysms due to Kawasaki disease.
Not a fit: Patients with active bleeding risks or contraindications to anticoagulant therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the understanding of rivaroxaban dosing and effectiveness in children with Kawasaki disease, potentially leading to better treatment outcomes.
How similar studies have performed: While this approach is focused on a specific population, similar pharmacokinetic studies in other pediatric populations have shown promise, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (RECRUITING)
Study contacts
- Study coordinator: Fang Liu, MD
- Email: liufang@fudan.edu.cn
- Phone: 18017590880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Kawasaki Disease, Coronary Artery Aneurysm, Rivaroxaban, Anticoagulant Drugs, Pharmacokinetics and Pharmacodynamics, Kawasaki disease, Coronary artery aneurysm, Population pharmacokinetic and pharmacodynamic