Rivaroxaban in Chinese Children With Giant Coronary Artery Aneurysm After Kawasaki Disease: a Pilot Study

What this Trial Is About

Researchers are evaluating a dosing regimen of rivaroxaban adjusted for age and bodyweight, equivalent to 15 mg, in Chinese children with giant coronary artery aneurysms following Kawasaki disease. This pilot study focuses on the feasibility of this dosing approach, aiming to provide preliminary data on its use in this population, which is at high risk for coronary artery thrombosis and major cardiovascular events due to their condition. The study builds on previous pharmacokinetic modeling and acknowledges challenges like increased bleeding risk and variability in young patients' development. The study involves administering rivaroxaban as an anticoagulant according to the proposed 15 mg-equivalent dosing regimen adjusted for age and weight. Patients will receive this treatment as part of dual antithrombotic therapy, including antiplatelet drugs, over a period of at least six months. This single-arm, single-center study does not include a comparison group and focuses on monitoring the effects of this dosing strategy in real-world clinical use. Participants will be followed for more than six months with regular assessments to record clinical outcomes such as new coronary artery thrombosis, major bleeding events, and adverse cardiovascular events. Rivaroxaban levels will be measured to evaluate the pharmacokinetic and pharmacodynamic aspects of the dosing regimen. Safety and any dose adjustments will also be evaluated during the study period. The total duration for each participant includes enrollment through six months of treatment and monitoring.

Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease