Actively Recruiting
Rivaroxaban Versus Warfarin for Thromboprophylaxis in Children Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease: A Multicenter, Open-label, Randomized Controlled Trial
Led by Children's Hospital of Fudan University · Updated on 2025-07-02
100
Participants Needed
1
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are exploring the use of rivaroxaban compared to warfarin for preventing blood clots in children over 2 years old with giant coronary artery aneurysms following Kawasaki disease. This condition requires lifelong anticoagulant treatment, which can be challenging for patients and families. The study aims to assess the feasibility, safety, and effectiveness of a dosing regimen tailored for Chinese children based on age and body weight. Participants will be randomly assigned in a 2:1 ratio to receive either rivaroxaban or warfarin, each combined with an antiplatelet drug such as aspirin or clopidogrel, for a period of three months. Rivaroxaban dosing is adjusted according to a 15 mg-equivalent model, while warfarin dosing is managed to maintain a specific blood clotting range. Monthly blood tests will monitor warfarin levels, and the choice of antiplatelet drug depends on medical history and physician advice. During the study, researchers will collect data on treatment effects, bleeding events, adverse reactions, and adherence to medication. The main outcomes measured include the occurrence of new blood clots, major or non-major bleeding events, and serious cardiovascular events within three months of starting treatment. Additional monitoring includes blood levels of rivaroxaban, clotting activity, changes in artery aneurysm size, and costs related to anticoagulation. The trial is planned to enroll 100 participants and is sponsored by Children's Hospital of Fudan University.
CONDITIONS
Brief Title
Rivaroxaban for Children Aged Over 2 Years With Giant Coronary Artery Aneurysms After Kawasaki Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Children aged 2 years or older
- Diagnosed with giant coronary artery aneurysm(s) after acute Kawasaki disease, confirmed by echocardiography with Z-score �3E�3D10 or artery diameter �3E�3D8mm
- Recommended to receive anticoagulant plus antiplatelet therapy for thromboprophylaxis for the next 3 months
- Able to tolerate oral feeding, nasogastric, or gastric feeding
You will not qualify if you...
- Active bleeding or bleeding risk that contraindicates anticoagulant therapy
- History of venous thromboembolism or related risk factors such as congenital heart disease, cancer, central venous catheter, or long-term immobility
- Presence of thrombus within giant coronary aneurysm confirmed by imaging
- Estimated glomerular filtration rate (eGFR) less than 30 mL/min/1.73 m2
- Platelet count below 100 x 10^9/L
- Liver disease causing coagulopathy or elevated liver enzymes beyond specified limits
- Sustained uncontrolled high blood pressure above 95th percentile for age
- Use of strong inhibitors of both CYP3A4 and P-glycoprotein (certain HIV protease inhibitors, systemic ketoconazole, itraconazole, voriconazole, posaconazole)
- Use of strong CYP3A4 inducers such as rifampicin, phenobarbital, phenytoin, carbamazepine
- Allergy or contraindications to study treatments
- Inability to cooperate with study procedures and follow-up
- Refusal to provide informed consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive anticoagulant treatment with either rivaroxaban plus aspirin or clopidogrel, or warfarin plus aspirin or clopidogrel, for thromboprophylaxis. Treatment duration is 3 months with monthly blood tests for those on warfarin to monitor INR levels.
Monthly visits for INR testing (warfarin group) and regular assessments during treatment
Trial Site Locations
Total: 1 location
1
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 201102
Actively Recruiting
Research Team
F
Fang Liu, MD
G
Guangan Dai
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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