ENNOBLE-ATE trial: an open-label, randomised, multi-centre, observational study of edoxaban for children with cardiac diseases at risk of thromboembolism

Children with cardiac diseases suffer from significant morbidity and mortality secondary to thromboembolic complications. Anticoagulant agents currently used for thromboprophylaxis have many limitations, including subcutaneous administration (low molecular weight heparins) and requirement for freque...

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Bibliographic Details
Published in:Cardiology in the young 2021-08, Vol.31 (8), p.1213-1219
Main Authors: Bhatt, Mihir D., Portman, Michael A., Berger, Felix, Jacobs, Jeffrey P., Newburger, Jane, Duggal, Anil, Grosso, Michael, Pandya, Grishma, Dave, Jay, Goldenberg, Neil A.
Format: Article
Language:English
Subjects:
Antagonists
Anticoagulants
Aspirin
Bleeding
Children
Clinical trials
Complications
Coronary artery disease
Disease prevention
Drug dosages
Health risks
Health services
Heart diseases
Heparin
Hypotheses
Low molecular weights
Molecular weight
Monitoring
Morbidity
Mortality
Mucocutaneous lymph node syndrome
Observational studies
Original Article
Other
Patient safety
Pediatrics
Pharmacodynamics
Pharmacokinetics
Pharmacology
Phylloquinone
Prophylaxis
Quality of life
Randomization
Safety
Telemedicine
Thromboembolism
Thrombosis
Vitamin K
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Summary:Children with cardiac diseases suffer from significant morbidity and mortality secondary to thromboembolic complications. Anticoagulant agents currently used for thromboprophylaxis have many limitations, including subcutaneous administration (low molecular weight heparins) and requirement for frequent monitoring via venipuncture (vitamin K antagonists). Edoxaban is an oral direct factor Xa inhibitor without need of monitoring. In the treatment of venous thromboembolism in adults, edoxaban has shown to be effective and safe. This manuscript summarises the rationale and design of a phase 3, open-label, randomised controlled trial to evaluate and compare the safety and efficacy of edoxaban against standard of care (namely, vitamin K antagonist and low molecular weight heparin) in children with cardiac diseases. A goal of 150 children with cardiac diseases at risk of thromboembolic complications who need primary or secondary anticoagulant prophylaxis will be recruited. Eligible children between 6 months and
ISSN:1047-9511
1467-1107
DOI:10.1017/S1047951121002523