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

Completed · Phase 2

Conditions studied: Thrombosis

In brief

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

Key facts

Study ID

NCT02981472

Run by

Bristol-Myers Squibb

People needed

192

Starts

2017-01-19

Expected to finish

2021-10-18

Last updated by the study team

2022-10-03

Who can join

Age: 0 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Phoenix Children'S Hospital — Phoenix, Arizona, United States
• University Of California San Diego — La Jolla, California, United States
• Children'S Hospital Colorado — Aurora, Colorado, United States
• Childrens Healthcare Of Atlanta — Atlanta, Georgia, United States
• Local Institution - 0008 — Indianapolis, Indiana, United States
• Local Institution - 0009 — Boston, Massachusetts, United States
• Local Institution - 0013 — Ann Arbor, Michigan, United States
• Childrens Mercy Hospital — Kansas City, Missouri, United States
• Local Institution - 0006 — Cincinnati, Ohio, United States
• Childrens Hospital Of Philadelphia — Philadelphia, Pennsylvania, United States
• Local Institution - 0012 — Charleston, South Carolina, United States
• Local Institution - 0011 — Houston, Texas, United States
• Primary Children's Hospital — Salt Lake City, Utah, United States
• Local Institution - 0055 — Seattle, Washington, United States
• Local Institution — CABA, Buenos Aires, Argentina
• Local Institution - 0030 — Parkville, Victoria, Australia
• Local Institution - 0001 — Vienna, Austria
• Local Institution - 0022 — Curitiba, Paraná, Brazil
• Instituto De Cardiologia Do Rio Grande Do Sul — Porto Alegre, Rio Grande do Sul, Brazil
• Local Institution - 0020 — Campinas, São Paulo, Brazil
• Instituto de Pesquisa PENSI — São Paulo, Brazil
• Universidade Federal De Sao Paulo — São Paulo, Brazil
• Local Institution - 0015 — Toronto, Ontario, Canada
• Local Institution - 0031 — HUS, Finland
• Local Institution - 0002 — Freiburg im Breisgau, Germany

Full record on ClinicalTrials.gov

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