Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery An
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 1
| Condition(s) | Kawasaki Disease, Pilot Study, Coronary Artery Aneurysm, Rivaroxaban |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| Summary | 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. |
| Who can participate | 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. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding; 4. Children aged 1 Month to\<18 years, bodyweight ≥ 2600g. Exclusion Criteria: 1. Active bleeding or bleeding risk contraindicating anticoagulant therapy 2. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central |
| Ages | 1 Month to 18 Years |
| Sex | All |
| Lead sponsor | Children's Hospital of Fudan University |
| Locations | Shanghai, Shanghai Municipality, China |
| Start date | 2024-01-10 |
| NCT ID | NCT06978439 |
| Official listing | https://clinicaltrials.gov/study/NCT06978439 |