ENNOBLE-ATE Study to Evaluate Edoxaban Tosylate

Condition: Cardiac disease, thromboembolism

Eligibility

Key Inclusion Criteria

  • Children with cardiac diseases who are at risk for thromboembolic complications (blood clots) and who require at least 3 months of anticoagulant preventive treatment. Either one of the following criteria may apply:
    • Children with cardiac disease who have a history of cardiac shunt occlusion (blockage)/thrombosis with shunt still in place OR
    • Children with cardiac disease who require anticoagulation for primary prevention of thromboembolism (TE)

Key Exclusion Criteria

  • Evidence of the following up to study group assignment:
    • Symptomatic venous or arterial TE
    • Asymptomatic venous or arterial TE
    • Asymptomatic intracardiac thrombosis 
Full Study Name

An Open-Label, Randomized, Parallel-Group, Multicenter, Observational Trial to Evaluate Safety and Efficacy of Edoxaban Tosylate in Children From 38 Weeks Gestational Age to Less than 18 Years of Age with Cardiac Diseases at Risk of Thromboembolic Events (IRB no. 51386)   

Summary

The purpose of this study is to examine the safety and effectiveness of a drug called edoxaban in children with cardiac diseases who are at risk of thromboembolic complications (blood clots) and require anticoagulation (blood thinning) medicine to prevent blood clots. The study aims to determine whether edoxaban is better than the standard treatment for such children. The study also seeks to learn how patients' blood tests may change after taking the drug. Participants will be randomly assigned to receive either the usual standard-of-care anticoagulants (e.g., heparin, vitamin K antagonists) or edoxaban. Edoxaban is an investigational drug in children that may reduce blood clots. 

Principal Investigator

Ruchira Garg, MD

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