A Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist (VKA) or Low Molecular Weight Heparin (LMWH) in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Anticoagulation

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

* Males and Females, 28 days to \< 18 years of age, inclusive
* Congenital or acquired heart diseases requiring chronic anticoagulation for thromboprophylaxis (eg, single ventricle physiology including all 3 stages of palliation, dilated cardiomyopathy, Kawasaki disease with coronary aneurysms, and pulmonary hypertension)
* Eligible participants include those who newly start anticoagulants and those who are currently on VKA or LMWH or other anticoagulants for thromboprophylaxis
* Able to tolerate enteral medication \[eg, by mouth, nasogastric tube, or gastric tube\]
* Participants 28 days to \< 3 months must be able to tolerate oral/nasogastric tube (NGT)/gastric tube (GT) feeds for at least 5 days prior to randomization

Exclusion Criteria:

* Recent thromboembolic events less than 6 months prior to enrollment
* Weight \< 3 kg
* Use of aggressive life-saving therapies such as ventricular assist devices (VAD) or extracorporeal membrane oxygenation (ECMO) at the time of enrollment
* Artificial heart valves and mechanical heart valves
* Known inherited bleeding disorder or coagulopathy (e.g. hemophilia, von Willebrand disease, etc.)
* Active bleeding at the time of enrollment
* Any major bleeding other than perioperative in the preceding 3 months
* Known intracranial congenital vascular malformation or tumor
* Confirmed diagnosis of a GI ulcer
* Known antiphospholipid syndrome (APS).

Other protocol defined inclusion/exclusion criteria apply

For more information on this trial, visit clinicaltrials.gov.