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RECRUITINGPhase 4INTERVENTIONAL

Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease

Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease: a Multicenter, Open-label, Parallel, Exploratory, Randomized Controlled Trial

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Based on population pharmacokinetic model-based simulation, a 15 mg-equivalent, age-, and bodyweight-adjusted dosing regimen for Chinese children with giant coronary artery aneurysms after acute Kawasaki disease was proposed. This exploratory trial aims to evaluate the feasibility, safety and effectiveness of rivaroxaban compared to warfarin for thromboprophylaxis in children aged over 2 years with giant coronary artery aneurysms after Kawasaki disease

Who May Be Eligible (Plain English)

Who May Qualify: 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 3 months; 3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding; 4. Children aged ≥ 2 years Who Should NOT Join This Trial: 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. An eGFR \<30mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile) 5. Platelet count \< 100 x 109/L 6. 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 7. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \>95 th age percentile 8. Concomitant use of strong inhibitors of both CYP3A4 and P-glycoprotein, including but not limited to all human weakened immune system virus protease inhibitors and the following azole-antimycotics agents: ketoconazole, itraconazole, voriconazole, posaconazole, if used systemically (fluconazole is allowed) 9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 3 months; 3. Participant should be able to tolerate oral feeding, nasogastric or gastric feeding; 4. Children aged ≥ 2 years 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. An eGFR \<30mL/min/1.73 m2 (For children younger than 1 year, serum creatinine results above 97.5th percentile) 5. Platelet count \< 100 x 109/L 6. 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 7. Sustained uncontrolled hypertension defined as systolic and/or diastolic blood pressure \>95 th age percentile 8. 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) 9. Concomitant use of strong inducers of CYP3A4, including but not limited to rifampicin, rifabutin, phenobarbital, phenytoin and carbamazepine 10. Hypersensitivity or any other contraindications listed in the local labeling for the comparator treatment or experimental treatment 11. Inability to cooperate with the study procedures and follow-up visits 12. Refuse to provide informed consent eGFR, estimated glomerular filtration rate; ULN, upper level of normal; TB, total bilirubin; CYP3A4, cytochrome P450 isoenzyme 3A4

Treatments Being Tested

DRUG

Rivaroxaban Oral Tablet [Xarelto]

Administered in an age- and bodyweight-adjusted, 15 mg-equivalent dose regimen proposed by model- and clinical evidence-informed precision dosing

DRUG

Aspirin or Clopidogrel

Aspirin \[3 \~5mg/(kg·d) once daily\] or Clopidogrel \[1.0 mg/kg; once daily\]

DRUG

Warfarin

Warfarin 0.05\~0.12 mg/(kg·d) once daily. INR should maintain within 1.5 to 2.5

Locations (1)

Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China