Key result
Edoxaban real-world safety and effectiveness in Brazilian patients with non-valvular atrial fibrillation will be evaluated in the prospective, observational EdoBRA study involving 700 patients followed for one year.
Why the study?
Additional research was needed to evaluate the real-world safety and effectiveness of edoxaban in routine clinical settings among Brazilian patients with non-valvular atrial fibrillation.
Does edoxaban affect clinically relevant bleeding and cardiovascular outcomes in Brazilian patients with non-valvular atrial fibrillation in a real-world setting?
Observational (n=700)
Yes
Does edoxaban affect clinically relevant bleeding and cardiovascular outcomes in Brazilian patients with non-valvular atrial fibrillation in a real-world setting?
The EdoBRA study will provide real-world data on the safety and effectiveness of edoxaban in Brazilian patients with non-valvular atrial fibrillation.
Edoxaban appears safe in real-world Brazilian NVAF patients; leaves open need for larger confirmatory studies.
Background: Clinical trials showed the safety of Edoxaban, a non-vitamin K-dependent oral anticoagulant (NOAC), and its efficacy to prevent stroke and systemic embolism in non-valvular atrial fibrillation (NVAF) patients and also to prevent and treat venous thromboembolism. However, additional research is needed to evaluate the safety and effectiveness of Edoxaban in a real-world scenario in the Brazilian population. Objective: In order to understand the risks and benefits of Edoxaban use in routine clinical settings, the EdoBRA study is being conducted to gain insight into the safety and effectiveness of Edoxaban use in non-preselected patients with NVAF in Brazil. Methods: The EdoBRA study is a multicenter, prospective, observational study conducted in 36 sites in Brazil. NVAF patients ≥ 18 years treated with commercially available Edoxaban who initiated treatment for at least 14 days and no longer than 90 days prior to enrollment, and who are not simultaneously participating in any interventional study are eligible for this study. Seven hundred patients are planned to be enrolled and one-year of follow up, with data collections expected at baseline and 3, 6, and 12 months after the study enrollment. The primary safety objective is ISTH Clinically Relevant Bleeding, and the secondary effectiveness objective focuses on relevant cardiovascular outcomes related to NVAF. Conclusion: EdoBRA observational study will generate relevant additional information about NOAC Edoxaban on various aspects of patient management in routine care, such as its safety and effectiveness profile in patients with NVAF in Brazil.
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Précoma et al. (2024) conducted an observational in Non-valvular atrial fibrillation (n=700). Edoxaban was evaluated on ISTH Clinically Relevant Bleeding (major bleeding and clinically relevant non-major bleeding). Edoxaban real-world safety and effectiveness in Brazilian patients with non-valvular atrial fibrillation will be evaluated in the prospective, observational EdoBRA study involving 700 patients followed for one year.
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