RE-COVERY DVT/PE: Rationale and design of a prospective observational study of acute venous thromboembolism with a focus on dabigatran etexilate

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Arquivos
art_AGENO_RECOVERY_DVTPE_Rationale_and_design_of_a_prospective_2017.PDF (224.46 KB)
Citações na Scopus
15
Tipo de produção
article
Data de publicação
2017
DOI
Scopus
Web of Science
PubMed
Título da Revista
ISSN da Revista
Título do Volume
Editora
SCHATTAUER GMBH-VERLAG MEDIZIN NATURWISSENSCHAFTEN
Autores
AGENO, Walter
HAN, Chee Kok
RASKOB, Gary E.
SCHELLONG, Sebastian
SCHULMAN, Sam
SINGER, Daniel E.
KIMURA, Karen
TANG, Wenbo
DESCH, Marc
Citação
THROMBOSIS AND HAEMOSTASIS, v.117, n.2, p.415-421, 2017
Projetos de Pesquisa
Unidades Organizacionais
Fascículo
Resumo
The therapeutic management of venous thromboembolism (VTE) is rapidly evolving. Following the positive results of pivotal large-scale randomised trials, the non-vitamin K antagonist oral anticoagulants (NOACs) represent an important alternative to standard anticoagulation. In phase III studies, dabigatran was as effective as, and significantly safer than warfarin. Additional information on real-world data of dabigatran is now warranted. RE-COVERY DVT/PE is a multi-centre, international, observational (i.e. non-interventional) study enrolling patients with acute DVT and/or PE within 30 days after objective diagnosis. The study is designed with two phases. Phase 1 has a cross-sectional design, enrolling approximately 6000 patients independently of treatment choice, with the aim of providing a contemporary picture of the management of VIE worldwide. Phase 2 has a prospective cohort design, with follow-up of one year, enrolling 8000 patients treated with dabigatran or vitamin K antagonists (VKAs) with the aim of comparing their safety, defined by the occurrence of major bleeding, and effectiveness, defined by the occurrence of symptomatic recurrent VIE. RE-COVERY DVT/PE will complement both the results of other observational studies in this field and the results of phase Ill studies with dabigatran, in particular by assessing its clinical benefit in various patient subgroups treated in routine clinical practice.
Palavras-chave
Deep-vein thrombosis, pulmonary embolism, dabigatran, anticoagulation
URI
https://observatorio.fm.usp.br/handle/OPI/28383
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Coleções
Artigos e Materiais de Revistas Científicas - HC/ICHC
Artigos e Materiais de Revistas Científicas - LIM/02
Artigos e Materiais de Revistas Científicas - ODS/03