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Rivaroxaban After Fontan Procedure in Children - Clinical Trial

What is the Purpose of this Study?

We are doing this study to learn about the safety and effectiveness of taking rivaroxaban for 12 months compared to aspirin in preventing blood clots after a Fontan Procedure.

What is the Condition Being Studied?

Post Fontan Procedure blood clot prevention in children

Who Can Participate in the Study?

To be in this study, you must be:
- A child between the ages of 2 to 8 years old
- Have had the Fontan heart procedure within 4 months before enrollment

Age Group

What is Involved?

If you decide to allow your child to join this study, your child will:
- Be randomized (like the flip of a coin) to receive:
-- Rivaroxaban (a study drug) OR
-- Aspirin as a blood thinner
- Have 5 onsite visits during the 12 month study period.  
- Have 3 echocardiograms at baseline, 6 and 12 months
- Give blood samples.

Study Details

Full Title
A Prospective, Open-Label, Active-Controlled Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety, and Efficacy of Rivaroxaban for Thromboprophylaxis in Pediatric Subjects 2 to 8 Years of Age after the Fontan Procedure.
Principal Investigator
Pediatric Cardiologist
Protocol Number
Phase III
Contact the Duke Recruitment Innovation Center