Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial

dc.contributor.authorKasner, Scott E.
dc.contributor.authorLavados, Pablo
dc.contributor.authorSharma, Mukul
dc.contributor.authorWang, Yongjun
dc.contributor.authorWang, Yilong
dc.contributor.authorDávalos, Antoni
dc.contributor.authorShamalov, Nikolay
dc.contributor.authorCunha, Luis
dc.contributor.authorLindgren, Arne
dc.contributor.authorMikulik, Robert
dc.contributor.authorArauz, Antonio
dc.contributor.authorLang, Wilfried
dc.contributor.authorCzlonkowska, Anna
dc.contributor.authorEckstein, Jens
dc.contributor.authorGagliardi, Rubens
dc.contributor.authorAmarenco, Pierre
dc.contributor.authorAmeriso, Sebastián F.
dc.contributor.authorTatlisumak, Turgut
dc.contributor.authorHart, Robert G.
dc.contributor.authorNAVIGATE ESUS Steering Committee and Investigators
dc.date.accessioned2022-05-13T19:53:33Z
dc.date.available2022-05-13T19:53:33Z
dc.date.issued2018
dc.descriptionAuthor Manuscriptes
dc.description.abstractBackground: The New Approach Rivaroxaban Inhibition of Factor Xa in a Global Trial vs. ASA to Prevent Embolism in Embolic Stroke of Undetermined Source (NAVIGATE-ESUS) trial is a randomized phase-III trial comparing rivaroxaban versus aspirin in patients with recent ESUS. Aims: We aimed to describe the baseline characteristics of this large ESUS cohort to explore relationships among key subgroups. Methods: We enrolled 7213 patients at 459 sites in 31 countries. Prespecified subgroups for primary safety and efficacy analyses included age, sex, race, global region, stroke or transient ischemic attack prior to qualifying event, time to randomization, hypertension, and diabetes mellitus. Results: Mean age was 66.9 ± 9.8 years; 24% were under 60 years. Older patients had more hypertension, coronary disease, and cancer. Strokes in older subjects were more frequently cortical and accompanied by radiographic evidence of prior infarction. Women comprised 38% of participants and were older than men. Patients from East Asia were oldest whereas those from Latin America were youngest. Patients in the Americas more frequently were on aspirin prior to the qualifying stroke. Acute cortical infarction was more common in the United States, Canada, and Western Europe, whereas prior radiographic infarctions were most common in East Asia. Approximately forty-five percent of subjects were enrolled within 30 days of the qualifying stroke, with earliest enrollments in Asia and Eastern Europe. Conclusions: NAVIGATE-ESUS is the largest randomized trial comparing antithrombotic strategies for secondary stroke prevention in patients with ESUS. The study population encompasses a broad array of patients across multiple continents and these subgroups provide ample opportunities for future research.es
dc.description.versionVersión enviadaes
dc.identifier.citationKasner, S. E., Lavados, P., Sharma, M., Wang, Y., Wang, Y., Dávalos, A., Shamalov, N., Cunha, L., Lindgren, A., Mikulik, R., Arauz, A., Lang, W., Czlonkowska, A., Eckstein, J., Gagliardi, R., Amarenco, P., Ameriso, S. F., Tatlisumak, T., Veltkamp, R., Hankey, G. J., … NAVIGATE ESUS Steering Committee and Investigators (2018). Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. Journal of stroke and cerebrovascular diseases : the official journal of National Stroke Association, 27(6), 1673–1682. https://doi.org/10.1016/j.jstrokecerebrovasdis.2018.01.027es
dc.identifier.urihttps://doi.org/10.1016/j.jstrokecerebrovasdis.2018.01.027es
dc.identifier.urihttp://hdl.handle.net/11447/6094
dc.language.isoenes
dc.subjectStrokees
dc.subjectCryptogenic strokees
dc.subjectCerebral embolismes
dc.subjectEmbolic Stroke of Undetermined Source (ESUS)es
dc.subjectStroke preventiones
dc.subjectRivaroxabanes
dc.subjectAspirines
dc.subjectRandomized triales
dc.titleCharacterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Triales
dc.typeArticlees
dcterms.sourceJournal of Stroke and Cerebrovascular Diseaseses

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