Analyzing Rivaroxaban in Chinese Children with Kawasaki Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.