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 people ages up to 17 years

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