Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm … (NCT06978439) | Clinical Trial Compass
RecruitingPhase 4
Model-informed Dose Optimization for Rivaroxaban in Children With Giant Coronary Artery Aneurysm After Kawasaki Disease
China10 participantsStarted 2024-01-10
Plain-language 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
Age range1 Month – 18 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Anticoagulant with antiplatelet drug therapy for anti-thromboprophylaxis is recommended for the next 6 months;
✓. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding;
✓. Children aged 1 Month to\<18 years, bodyweight ≥ 2600g.
Exclusion criteria
✕. Active bleeding or bleeding risk contraindicating anticoagulant therapy
✕. With history of venous thromboembolism or risk factors related with venous thromboembolism, like congenital heart disease, carcinoma, central venous catheter or long-term immobilization.
✕. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
✕
What they're measuring
1
Occurrence of new thrombosis in coronary arteries
Timeframe: From enrollment to the 6th month after treatment
2
Composite of Major bleeding or Clinically relevant non-major bleeding event
Timeframe: From enrollment to the 6th month after treatment
. An eGFR \<30 mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)
✕. Platelet count \< 100 x 109/L
✕. Hepatic disease which is associated with either: coagulopathy leading to a clinically relevant bleeding risk, or alanine aminotransferase \> 5x ULN or total bilirubin \> 2x ULN with direct bilirubin \> 20% of the total
✕. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \>95 th age percentile
✕. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human immunodeficiency virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed)