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

Korábbi kezelés

• 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)
• Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine

Más betegség

• 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
• Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment

Laborértékek

• 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
• Refuse to provide informed consent
  • eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4

Életkor

• Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure >95 th age percentile

Egyéb

• Inability to cooperate with the study procedures and follow-up visits

• 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.