Current Environment:

Summary

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

Conditions

Thrombosis

Recruitment Status

Completed

Eligibility 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

Intervention

Intervention Type

Intervention Name

Drug

Apixaban

Drug

Vitamin K Antagonist (VKA)

Drug

Low Molecular Weight Heparin (LMWH)

Phase

Phase 2

Gender

All

Minimum Age

N/A

Maximum Age

17 Years

Download Date

May 18, 2022

Principal Investigator

N/A

Primary Contact Information

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

Contact

For more information and to contact the study team: