Condition: Kawasaki Disease · Pilot Study · Coronary Artery Aneurysm · Sponsor: Children's Hospital of Fudan University
Based on a population pharmacokinetic model-based dose optimization study, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after Kawasaki disease was proposed. This single-center, single-arm, pilot study aims to evaluate the feasibility of the 15 mg-equivalent dosing regimen within a limited sample size. Patients will be followed for more than 6 months. Clinical outcomes, including coronary artery thrombosis, major adverse cardiovascular events, and bleeding events, will be recorded. Rivaroxaban levels will be measured to assess the robustness of the model-informed dose optimization.
This description comes directly from the study's public registry record.
Fang Liu, MD · 18017590880 · liufang@fudan.edu.cn
Guangan Dai, MD · 13580762996 · gadai24@m.fudan.edu.cn
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| Children's Hospital of Fudan University | Shanghai, Shanghai Municipality, China | Recruiting |
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Source record: clinicaltrials.gov/study/NCT06978439