NCT06993636 Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
| NCT ID | NCT06993636 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Children's Hospital of Fudan University |
| Condition | Kawasaki Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-01-01 |
| Primary Completion | 2025-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 60 participants in total. It began in 2023-01-01 with a primary completion date of 2025-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility 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
Contact & Investigator
Fang Liu, MD
STUDY DIRECTOR
Children's Hospital of Fudan University
Frequently Asked Questions
Who can join the NCT06993636 clinical trial?
This trial is open to participants of all sexes, aged 2 Years or older, up to 18 Years, studying Kawasaki Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06993636 currently recruiting?
Yes, NCT06993636 is actively recruiting participants. Contact the research team at liufang@fudan.edu.cn for enrollment information.
Where is the NCT06993636 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06993636 clinical trial?
NCT06993636 is sponsored by Children's Hospital of Fudan University. The principal investigator is Fang Liu, MD at Children's Hospital of Fudan University. The trial plans to enroll 60 participants.