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, 34 weeks adjusted gestational age to < 18 years of age

- 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 patients 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]

Exclusion Criteria:

- Recent thromboembolic events less than 6 months prior to enrollment

- 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

Other protocol defined inclusion/exclusion criteria could apply