Status:
RECRUITING
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Lead Sponsor:
Children's Hospital of Fudan University
Conditions:
Kawasaki Disease
Coronary Artery Aneurysm
Eligibility:
All Genders
2-18 years
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 co...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06993636
Start Date
January 1 2023
End Date
December 31 2026
Last Update
May 29 2025
Active Locations (1)
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1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102