NCT06993636Recruiting
Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years
Population Pharmacokinetic/Pharmacodynamic Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years With Giant Coronary Artery Aneurysm After Kawasaki Disease
Source: ClinicalTrials.gov · Last updated 29 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 60 (estimated)
- First submitted
- 11 May 2025
- Start date
- 1 Jan 2023
- Primary completion date
- 31 Dec 2025
- Lead sponsor
- Children's Hospital of Fudan University
- Diseases
- Coronary artery disease
- NCT number
- NCT06993636
What you commit to
- Study type: Observational
- Planned participants: 60
- From 1 Jan 2023 to the primary completion date, 31 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients participating in clinical trials of other drugs at the same time
Other illness
- 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
Who the study is looking for
- 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
Age in the registry: 2 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Children's Hospital Of Fudan University Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.