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Study Design of a Brazilian Observational Study of Edoxaban in Patients with Atrial Fibrillation (EdoBRA)
被引:0
|作者:
Precoma, Dalton Bertolim
[1
]
da Silva, Rafael Paletta
[2
]
Nakamoto, Allyson
[2
]
Omar, Viviane Mariz
[2
]
Lopes, Danilo
[2
]
Saraiva, Jose Francisco Kerr
[3
,4
]
机构:
[1] Hosp Angelina Caron, Curitiba, PR, Brazil
[2] Daiichi Sankyo Brasil Farmaceut, Sao Paulo, SP, Brazil
[3] Pontificia Univ Catolica Campinas, Campinas, SP, Brazil
[4] Inst Pesquisa Clin Campinas IPECC, Rua Oswaldo Oscar Barthelson 1209, BR-13060080 Campinas, SP, Brazil
关键词:
Oral Anticoagulants;
Edoxaban;
Observational Study;
Safety;
Efficacy;
FACTOR XA INHIBITOR;
STROKE PREVENTION;
WARFARIN;
MULTICENTER;
DISEASE;
D O I:
10.36660/abc.20230392i
中图分类号:
R5 [内科学];
学科分类号:
1002 ;
100201 ;
摘要:
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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