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

• Status: Recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Collaborators: Pediatric Heart Network; Pfizer
• Treatments: Apixaban; Calcium heparin; Dalteparin; Enoxaparin; Heparin; Heparin, Low-Molecular-Weight; Tinzaparin; Vitamin K; Vitamins; Warfarin

Criteria

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