Pharmacometrics Analysis of Rivaroxaban in Chinese Children Aged Over 2 Years

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-01

Study Completion Date

2026-12-31

Brief Summary

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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

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Detailed Description

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Conditions

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Kawasaki Disease Coronary Artery Aneurysm Rivaroxaban Anticoagulant Drugs Pharmacokinetics and Pharmacodynamics

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Rivaroxaban

Rivaroxaban as anticoagulant will be administered with antiplatelet drug for long-term antithrombotic treatment, following a model-based optimized dosing regimen. Rivaroxaban plasma concentration and rivaroxaban-calibrated Anti-FXa activity are measured for clinical monitoring

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No