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 Calcium heparin Apixaban Heparin Heparin, Low-Molecular-Weight Dalteparin 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

Other protocol defined inclusion/exclusion criteria could apply

Locations

  • University Of California San Diego accepting new patients
    La Jolla California 92093-0641 United States
  • Local Institution not yet accepting patients
    Phoenix Arizona 85016 United States

Details

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