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Rivaroxaban for Children With Giant Coronary Artery Aneurysms After Kawasaki Disease

Kawasaki Disease Clinical Trial

Official title:
Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial

Clinical Trial Summary

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children with giant coronary artery aneurysms after Kawasaki disease

Clinical Trial Description

Lifelong anticoagulant treatment is required in children with giant coronary artery aneurysm after Kawasaki disease, imposing social and psychologic burdens on patients and parents. Rivaroxaban is a potential oral anticoagulant in this population. Considering the impact of ethnic difference and growth development, we proposed a Chinese-specific, optimized dosing regimen based on model- and clinical evidence-informed precision dosing. This study is a multicenter, open-label, exploratory, randomized controlled trial to evaluate the feasibility, safety and effectiveness of rivaroxaban for thromboprophylaxis in Chinese children with giant coronary artery aneurysms after Kawasaki disease, following the 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen. Participants will be randomly assigned to the control or experimental groups. Randomization ratio will be 1:1. The control group will receive warfarin plus aspirin or clopidogrel, and the experimental group will receive Rivaroxaban plus aspirin or clopidogrel. Baseline characteristics, treatment effect outcomes, bleeding events, adverse events and compliance of intervention of each participant will be collected. Because this is an exploratory study and the low incidence of giant coronary artery aneurysm in children with Kawasaki disease, the study plans to recruit 100 participants. The aims include: - The feasibility - The safety and efficacy profile of the optimized, 15 mg-equivalent dosing regimen - The group differences in safety and treatment effect for antithromboprophylaxis between warfarin and rivaroxaban ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05643651
Study type Interventional
Source Children's Hospital of Fudan University
Contact Fang Liu, MD
Phone 18017590880
Email liufang@fudan.edu.cn
Status Not yet recruiting
Phase Phase 4
Start date March 1, 2024
Completion date March 1, 2026
View Details
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