Summary

for people ages up to 17 years (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

Summary

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

Official Title

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

Keywords

Thrombosis Heart Diseases Vitamins Vitamin K Heparin Calcium heparin Heparin, Low-Molecular-Weight Dalteparin Apixaban Vitamin K Antagonist (VKA) Low Molecular Weight Heparin (LMWH) LMWH/VKA

Eligibility

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
  • Known inherited or acquired thrombotic disorders (Antiphoshpholipid syndrome (APS)).

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • University Of California San Diego accepting new patients
    La Jolla California 92093-0641 United States
  • Phoenix Children'S Hospital accepting new patients
    Phoenix Arizona 85016 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
Investigator Inquiry Form
FDA Safety Alerts and Recalls
ID
NCT02981472
Phase
Phase 2
Study Type
Interventional
Last Updated