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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
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

NCT02981472

CompletedPhase 2

Sponsor: Bristol-Myers Squibb

Conditions: Thrombosis

Interventions: Apixaban, Vitamin K Antagonist (VKA), Low Molecular Weight Heparin (LMWH)

Countries: United States, Argentina, Australia, Austria, Brazil, Canada, Finland, Germany

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

Eligibility overview

Sex: ALL

Age: 28 Days to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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
Locations (46)
  • Phoenix, Arizona, United States
  • La Jolla, California, United States
  • Aurora, Colorado, United States
  • Atlanta, Georgia, United States
  • Indianapolis, Indiana, United States
  • Boston, Massachusetts, United States
  • Ann Arbor, Michigan, United States
  • Kansas City, Missouri, United States
  • Cincinnati, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Charleston, South Carolina, United States
  • Houston, Texas, United States
  • Salt Lake City, Utah, United States
  • Seattle, Washington, United States
  • CABA, Buenos Aires, Argentina
  • Parkville, Victoria, Australia
  • Vienna, Austria
  • Curitiba, Paraná, Brazil
  • Porto Alegre, Rio Grande do Sul, Brazil
  • Campinas, São Paulo, Brazil
  • São Paulo, Brazil
  • São Paulo, Brazil
  • Toronto, Ontario, Canada
  • HUS, Finland
  • Freiburg im Breisgau, Germany
  • Hamburg, Germany
  • München, Germany
  • Petah Tikva, Israel
  • Tel Litwinsky, Israel
  • Rome, Roma, Italy
  • + 16 more on CT.gov