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

A Prospective, Randomized, Open Label, Multi-center Study of the Safety and Pharmacokinetics of Apixaban Versus Vitamin K Antagonist or LMWH in Pediatric Subjects With Congenital or Acquired Heart Disease Requiring Chronic Anticoagulation for Thromboembolism Prevention

To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for 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