Rivaroxaban for children over 2 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
This trial will test whether rivaroxaban given with an antiplatelet medicine is a safe and practical alternative to warfarin for preventing clots in children aged 2 and older with giant coronary artery aneurysms after Kawasaki disease.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 2 Years to 18 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05643651 on ClinicalTrials.gov |
What this trial studies
The trial uses a Chinese-specific, model-informed 15 mg-equivalent, age- and weight-adjusted dosing regimen for rivaroxaban developed from pharmacokinetic simulations and prior pilot data. It is an open-label, randomized, exploratory trial with a 2:1 randomization comparing rivaroxaban plus aspirin or clopidogrel to warfarin plus aspirin or clopidogrel. Study staff will collect baseline features, bleeding events, adverse events, adherence, and thrombotic outcomes to characterize feasibility, safety, and effectiveness. Given the low incidence of giant coronary aneurysms, the study prioritizes safety and feasibility signals over definitive efficacy conclusions.
Who should consider this trial
Good fit: Children aged 2 years and older with giant coronary artery aneurysm(s) after the acute stage of Kawasaki disease who are recommended to receive anticoagulant plus antiplatelet thromboprophylaxis are the intended participants.
Not a fit: Children with active bleeding, confirmed thrombus in the aneurysm, other contraindications to anticoagulation, or those younger than 2 years are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, rivaroxaban could simplify lifelong anticoagulation for these children by offering a fixed-dose oral option that requires less monitoring than warfarin.
How similar studies have performed: A prior small pilot of 11 Chinese pediatric patients using this optimized dosing showed favorable feasibility with no thrombosis or major bleeding over six months, but larger randomized evidence is limited.
Eligibility criteria
Show full inclusion / exclusion 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 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
Where this trial is running
Shanghai, Shanghai Municipality
- Children's Hospital of Fudan University — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Fang Liu, MD
- Email: liufang@fudan.edu.cn
- Phone: 18017590880
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.