Venous Thromboembolism Treatment with Apixaban – Phase IV

Study of Pediatric Subjects Requiring Anticoagulation for the Treatment of a Venous Thromboembolic Event

Protocol Description

This multi-center international research study assesses the effectiveness of the anti-clotting drug apixaban in the treatment pediatric patients with venous thromboembolism, a blood clot in a vein. The effects of the drug, which has been approved for adults, will be compared to the effects of standard drugs currently used by doctors to treat blood clots, including vitamin K antagonists, which inhibit the body from making proteins that produce blood clots, and low-molecular weight heparins and unfractionated heparin, which prevent the body from making blood clots.

Study Level: Phase IV

Eligibility Criteria

While this study is designed for patients newborn through 17 years of age, it is currently enrolling participants from 3 months to 2 years old, who have a venous thromboembolism confirmed by imaging.
Males and Females: Ages 3 months to 2 years


Participants will be randomly assigned to take the study drug or standard therapy. The study drug will be dispensed in a weight-adjusted dose, to be taken orally twice a day during a 12-week study period. (Standard therapy may involve oral dosing or an injection.) Participants will need to visit the clinic for examinations, imaging and blood sampling.
Visits: 7 plus a follow up call or visit 35 days after end of treatment
Duration: About 17 weeks

Status: Open to Enrollment

Source(s) of Support

Bristol-Myers Squibb

Primary Investigator

Thomas Diacovo, MD

Contact Information

For more information about the study or enrollment, please contact:
Dawn Thomas, CRN
Jessica Cagle, CRN