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

Description

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

Study Start Date

January, 04 2017

Estimated Completion Date

September 2020

Interventions

  • Drug: Low Molecular Weight Heparin (LMWH)
  • Drug: Apixaban
  • Drug: Vitamin K Antagonist (VKA)

Study ID

Bristol-Myers Squibb -- CV185-362

Status

Recruiting

Trial ID

NCT02981472

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

150

Sponsor

Bristol-Myers Squibb

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
  • Prosthetic 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 Other protocol defined inclusion/exclusion criteria could apply

Gender

All

Ages

34 Weeks to 17 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (169)

Study Location Distance Name Phone Email
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Boston Childrens Hospital - Boston, Massachusetts 2.6 miles Christina Vanderpluym Site 0009 617-355-6329 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
Childrens Hospital Of Philadelphia - Philadelphia, Pennsylvania 270.8 miles Andrew Glatz Site 0007 215-590-1790 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
University Of Michigan - Ann Arbor, Michigan 645.2 miles Caren Goldberg Site 0013 734-764-5177 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Cincinnati Childrens Hospital Medical Center - Cincinnati, Ohio 735.6 miles James Cnota Site 0006 513-803-1153 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Riley Hospital For Children - Indianapolis, Indiana 805.0 miles R Mark Payne Site 0008 317-278-7188 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Medical University Of South Carolina - Charleston, South Carolina 821.2 miles Andrew Atz Site 0012 843-876-1698 None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Childrens Healthcare Of Atlanta - Atlanta, Georgia 932.0 miles Lazaros Kochilas Site 0010 None None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Primary Childrens Hospital - Salt Lake City, Utah 2,093.2 miles Lindsay May Site 0005 801-587-9104 None
Local Institution - Phoenix, Arizona 2,294.8 miles Site 0039 None None
Local Institution - Phoenix, Arizona 2,294.8 miles Site 0030 None None
Local Institution - Phoenix, Arizona 2,294.8 miles Site 0043 None None
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