Rivaroxaban for Children With Giant Coronary Artery Aneurysms After Kawasaki Disease

Launched by CHILDREN'S HOSPITAL OF FUDAN UNIVERSITY · Dec 6, 2022

Keywords

ClinConnect Summary

Lifelong anticoagulant treatment is required in children with giant coronary artery aneurysm after Kawasaki disease, imposing social and psychologic burdens on patients and parents. Rivaroxaban is a potential oral anticoagulant in this population. Considering the impact of ethnic difference and growth development, we proposed a Chinese-specific, optimized dosing regimen based on model- and clinical evidence-informed precision dosing.

This study is a multicenter, open-label, exploratory, randomized controlled trial to evaluate the feasibility, safety and effectiveness of rivaroxaban for thr...

Gender

ALL

Eligibility criteria

• 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 antithromboprophylaxis 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 venous catheter or long-term immobilization.
• • 3. Thrombus within giant coronary aneurysm was confirmed by previous imaging examinations, including two-dimensional echocardiography, computed tomography angiography in coronary artery or coronary angiography
• • 4. If taking warfarin before recruitment, INR should reach the target range (1.5-2.5) in three consecutive tests in the past month, and each test at least one week apart.
• • 5. An eGFR \<30mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile)
• • 6. Platelet count \< 100 x 109/L
• • 7. 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
• • 8. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \>95 th age percentile
• • 9. 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)
• • 10. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine
• • 11. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment
• • 12. Inability to cooperate with the study procedures and follow-up visits
• • 13. Refuse to provide informed consent eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin (TB); CYP3A4, cytochrome P450 isoenzyme 3A4

Trial Officials