CV185362 Pediatric Anticoagulation for Prevention of Thromboembolism
Research type
Research Study
Full 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
IRAS ID
218035
Contact name
Frances Bu'Lock
Contact email
Sponsor organisation
Bristol-Myers Squibb International Corporation
Eudract number
2016-001247-39
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
4 years, 1 months, 16 days
Research summary
This is a multicentre, phase II study of Apixaban in children (aged 0 to <18) with congenital or acquired heart disease requiring chronic treatment with anticoagulants (blood thinners) to prevent blood clots. Approximately 150 patients will take part, 8 will be enrolled from UK. The study is sponsored by Bristol-Myers Squibb. The purpose is to find out whether Apixaban is safe for children, and how much Apixaban will be in their blood when they take a certain dose.
There are limitations to the current available anticoagulants for children with congenital or acquired heart disease, including unwanted side effects (reduced bone mineral density and reduced platelets in the blood). Furthermore, these agents do not have oral paediatric formulations (and some only available by infusion into a vein) and require monitoring. This research is to evaluate Apixaban as a potential new treatment option for this group.Following a screening period, eligible patients will be randomized to receive Apixaban or standard treatment (Vitamin K antagonist or low molecular weight heparin as selected by the study doctor). Patients assigned to Apixaban treatment will take Apixaban twice per day as an oral solution or tablet by mouth or as solution by nasogastric tube, dependant on age, weight and ability to swallow.
Patients will undergo the following study procedures: physical exams, measurement of vital signs such as blood pressure, respiratory rate, height, weight, heart rate, body temperature as well as blood sample collections for routine safety testing and study specific testing. Patients will also have a bone density scan before they start and after they finish study treatment and be required to complete questionnaires to assess their quality of life.
Patients will be treated for up to 12 months or until treatment for prevention of blood clotting is no longer required. They will then have a follow-up visit 2 months later.REC name
South Central - Berkshire Research Ethics Committee
REC reference
17/SC/0083
Date of REC Opinion
7 Jul 2017
REC opinion
Further Information Favourable Opinion