Apixiban for Pediatric Venous Thromboembolic Event (VTE) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to learn about the safety of apixiban when compared to other blood thinner medicines used to treat VTE.
Venous Thromboembolism (VTE) (blood clots) in Children
Who Can Participate in the Study?
To be in this study, your child must:
- Be a newborn to 17 years old.
- Have a confirmed VTE (blood clot) with imaging (CT scan, MRI, or ultrasound)
- Manage the VTE with blood thinner medicine for at least 12 weeks (at least 6 weeks for neonates)
- Not have a mechanical heart valve, active bleeding or considered high risk of bleeding
- Not be allergic to apixiban
What is Involved?
If you choose to have your child join this study, your child will:
- Be randomized (like drawing names from a hat) to one of two treatments:
-- Apixiban (the study drug)
-- Standard treatment with anticoagulants (blood thinners)
- Have blood tests
- Have imaging tests (for example, ultrasound, CT scans, MRIs) to confirm condition, around the middle of the treatment and at the end of treatment.
- Note: you will know which treatment your child is receiving