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Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years | Clinical Trials | Clareo Health

RECRUITING

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

NCT06993636•Children's Hospital of Fudan University

View on ClinicalTrials.gov

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

Age

2 - 18 years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Children's Hospital of Fudan University

Shanghai, Shanghai Municipality, China

Key Dates

Start Date

January 1, 2023

Primary Completion Date

December 31, 2025

Completion Date

December 31, 2026

Last Updated

May 29, 2025

Enrollment

ESTIMATED participants

Conditions

Kawasaki DiseaseCoronary Artery AneurysmRivaroxabanAnticoagulant DrugsPharmacokinetics and Pharmacodynamics

Contacts

Fang Liu, MD

CONTACT

18017590880 liufang@fudan.edu.cn

Guangan Dai, MD

CONTACT

13580762996 gadai24@m.fudan.edu.cn

Kawasaki MATCH Trial

NCT07291245

Kawasaki Disease

View study

RECRUITINGPHASE1

Phase I Study of MT1011 Injection in Healthy Subjects

NCT07024160

Used in Patients Receiving Anticoagulant Therapy (e.g., Rivaroxaban or Apixaban, Inhibitors of Coagulation Factor Xa) Who Require Reversal of Anticoagulation

View study

RECRUITINGPHASE4

Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Inclusion Criteria

Exclusion Criteria

Kawasaki MATCH Trial

Phase I Study of MT1011 Injection in Healthy Subjects

Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Doxycycline Treatment to Prevent Progressive Coronary Artery Dilation in Children With Kawasaki Disease

Clinical Study on an Artificial Intelligence-Assisted Chest Radiograph Model Based on Big Data and Deep Learning for Early Detection of Kawasaki Disease

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