Evidence map›Paper›PMID 38695465›Full record

Observational studyArquivos brasileiros de cardiologia2024

Study Design of a Brazilian Observational Study of Edoxaban in Patients with Atrial Fibrillation (EdoBRA).

Dalton Bertolim Précoma, Rafael Paletta da Silva, Allyson Nakamoto, Viviane Mariz Omar, Danilo Lopes, José Francisco Kerr Saraiva

Open access · diamondAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in Arquivos brasileiros de cardiologia, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact, top 88% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed, 0 citations in OpenAlex.

  1. Observational
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors at 3 institutions in 3 countries.

Dalton Bertolim PrécomaHospital Angelina Caron, Curitiba, PR - Brasil.ORCID 0000-0002-1187-8690
Rafael Paletta da SilvaDaiichi Sankyo Brasil Farmacêutica, São Paulo, SP - Brasil.
Allyson NakamotoDaiichi Sankyo Brasil Farmacêutica, São Paulo, SP - Brasil.
Viviane Mariz OmarDaiichi Sankyo Brasil Farmacêutica, São Paulo, SP - Brasil.
Danilo LopesDaiichi Sankyo Brasil Farmacêutica, São Paulo, SP - Brasil.
José Francisco Kerr SaraivaPontifícia Universidade Católica de Campinas, Campinas, SP - Brasil.
Daiichi Sankyo (Germany) · DEAngelina College · USPontifícia Universidade Católica de Campinas · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundClinical 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.

objectiveIn 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.

methodsThe 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.

conclusionEdoBRA 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.

Indexed as

Atrial FibrillationFactor Xa InhibitorsPyridinesStrokeThiazolesAnticoagulantsBrazilHemorrhageHumansProspective StudiesResearch DesignTime FactorsTreatment OutcomeAnticoagulantsedoxabanFactor Xa InhibitorsPyridinesThiazoles

Identifiers

PMID38695465
PMCPMC12092049
OpenAlexW4396658724

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.