Congenital heart diseaseRandomised controlled trial
Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease
- Randomised controlled trial
- phase 2
- open-label
- 2:1 randomisation
- multinational
Authors' conclusion
In this pediatric multinational, randomized trial, bleeding and thromboembolism were infrequent on apixaban and SOC.
Study context
- Population
- Children (28 days to <18 years) with congenital or acquired heart disease requiring thromboprophylaxis
- Participants
- 192 children
- Comparison
- Apixaban vs standard of care
- Apixabann = 129
- Standard of care (SOC)n = 63reference
- Primary endpoint
- Composite of:
- Adjudicated major
- Clinically relevant nonmajor bleeding
- Follow-up
- 1 year
Primary result
Major or clinically relevant nonmajor bleeding
% difference
−4.0
95% CI −12.8 to 0.8
Events by treatment group
Apixaban vs SOC
% difference −4.0 (95% CI −12.8 to 0.8)
As reported in the abstract
Secondary outcomes
events
| Outcome | Apixaban | SOC |
|---|---|---|
| Thromboembolic events and deaths | 0 | 0 |
Pharmacokinetics
- Apixaban pediatric pharmacokinetics (PK) steady-state exposures consistent with adult levels
Safety
All bleeding events
- All bleeding events: driven by 12 apixaban participants with ≥4 minor bleeding events
Original publication
Apixaban for Prevention of Thromboembolism in Pediatric Heart Disease. J Am Coll Cardiol. Published 12 December 2023. doi:10.1016/j.jacc.2023.10.010
Summarised from the published abstract; every number is checked against it