At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 192 enrolled
Drug / intervention
Apixaban +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating Apixaban, Vitamin K Antagonist (VKA), and 1 other intervention for Thrombosis. Completed, enrolled 192 participants across 46 sites in 14 countries.
Detailed Summary
To investigate the safety and pharmacokinetics of apixaban in children with congenital or acquired heart disease who have a need for anticoagulation.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsThrombosis
CountriesArgentina, Australia, Austria, Brazil, Canada, Finland, Germany, Israel, Italy, Mexico, Russia, Spain, United Kingdom, United States
CollaboratorsPediatric Heart Network, Pfizer
Timeline
Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedDec 2016
Enrollment StartJan 2017
Primary CompletionOct 2021
TodayJul 2026
First PostedDec 5, 2016
Enrollment StartJan 19, 2017
Primary CompletionOct 18, 2021
TodayJul 2, 2026
Enrollment to primary: 4.7 yearsPosted 9.6 years ago
Interventions
Apixabandrug
Specified dose on specified days
Vitamin K Antagonist (VKA)drug
Specified dose on specified days
Low Molecular Weight Heparin (LMWH)drug
Specified dose on specified days