Edoxaban for Prevention of Blood Vessels Being Blocked by Clots (Thrombotic Events) in Children at Risk Because of Cardiac Disease

Summary

A committee will judge the safety and effectiveness of edoxaban and the regular treatment (standard of care). All children in the study will receive free treatment. They will have a 2 in 3 chance to receive edoxaban, and a 1 in 3 chance to receive the standard of care for preventing blood clots. The study will find out if edoxaban is safer and more effective than the standard of care.

Timeline

Start

2018-05-15

Primary completion

2021-12-03

Completion

2021-12-03

Publications

• Portman MA, Jacobs JP, Newburger JW, Berger F, Grosso MA, Duggal A, Tao B, Goldenberg NA; ENNOBLE-ATE Trial Investigators. Edoxaban for Thromboembolism Prevention in Pediatric Patients With Cardiac Disease. J Am Coll Cardiol. 2022 Dec 13;80(24):2301-2310. doi: 10.1016/j.jacc.2022.09.031. Epub 2022 Oct 31.

Drugs

Indications