Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial

Simple item page
dc.contributor.authorHart, Robert
dc.contributor.authorSharma, Mukul
dc.contributor.authorMundl, Hardi
dc.contributor.authorShoamanesh, Ashkan
dc.contributor.authorKasner, Scott
dc.contributor.authorBerkowitz, Scott
dc.contributor.authorPare, Guillaume
dc.contributor.authorKirsch, Bodo
dc.contributor.authorPogue, Janice
dc.contributor.authorPater, Calin
dc.contributor.authorPeters, Gary
dc.contributor.authorDavalos, Antoni
dc.contributor.authorLang, Wilfried
dc.contributor.authorWang, Yongjun
dc.contributor.authorWang, Yilong
dc.contributor.authorCunha, Luis
dc.contributor.authorEckstein, Jens
dc.contributor.authorTatlisumak, Turgut
dc.contributor.authorShamalov, Nikolay
dc.contributor.authorMikulik, Robert
dc.contributor.authorLavados, Pablo
dc.contributor.authorHankey, Graeme
dc.contributor.authorCzlonkowska, Anna
dc.contributor.authorToni, Danilo
dc.contributor.authorAmeriso, Sebastian
dc.contributor.authorGagliardi, Rubens
dc.contributor.authorAmarenco, Pierre
dc.contributor.authorBereczki, Daniel
dc.contributor.authorUchiyama, Shinichiro
dc.contributor.authorLindgren, Arne
dc.contributor.authorEndres, Matthias
dc.contributor.authorBrouns, Raf
dc.contributor.authorYoon, Byung-Woo
dc.contributor.authorNtaios, George
dc.contributor.authorVeltkamp, Roland
dc.contributor.authorMuir, Keith
dc.contributor.authorOzturk, Serefnur
dc.contributor.authorArauz, Antonio
dc.contributor.authorBornstein, Natan
dc.contributor.authorBryer, Alan
dc.contributor.authorO’Donnell, Martin
dc.contributor.authorWeitz, Jeffrey
dc.contributor.authorPeacock, Frank
dc.contributor.authorThemeles, Ellison
dc.contributor.authorConnolly, Stuart
dc.date.accessioned2017-12-15T19:32:55Z
dc.date.available2017-12-15T19:32:55Z
dc.date.issued2016
dc.description.abstractBackground: Embolic strokes of undetermined source comprise up to 20% of ischemic strokes. The stroke recurrence rate is substantial with aspirin, widely used for secondary prevention. The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source international trial will compare the efficacy and safety of rivaroxaban, an oral factor Xa inhibitor, versus aspirin for secondary prevention in patients with recent embolic strokes of undetermined source. Main hypothesis: In patients with recent embolic strokes of undetermined source, rivaroxaban 15 mg once daily will reduce the risk of recurrent stroke (both ischemic and hemorrhagic) and systemic embolism (primary efficacy outcome) compared with aspirin 100 mg once daily. Design: Double-blind, randomized trial in patients with embolic strokes of undetermined source, defined as nonlacunar cryptogenic ischemic stroke, enrolled between seven days and six months from the qualifying stroke. The planned sample size of 7000 participants will be recruited from approximately 480 sites in 31 countries between 2014 and 2017 and followed for a mean of about two years until at least 450 primary efficacy outcome events have occurred. The primary safety outcome is major bleeding. Two substudies assess (1) the relative effect of treatments on MRIdetermined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. Summary: The New Approach riVaroxaban Inhibition of Factor Xa in a Global trial versus ASA to prevenT Embolism in Embolic Stroke of Undetermined Source trial is evaluating the benefits and risks of rivaroxaban for secondary stroke prevention in embolic strokes of undetermined source patients. Main results are anticipated in 2018.
dc.format.extent9
dc.identifier.citationHart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154
dc.identifier.urihttp://hdl.handle.net/11447/1767
dc.identifier.urihttp://doi.org/10.1177/2396987316663049
dc.language.isoen_US
dc.publisherSage Publications
dc.subjectStroke
dc.subjectcryptogenic stroke
dc.subjectcerebral embolism
dc.subjectembolic stroke of undetermined source
dc.subjectstroke prevention
dc.subjectrivaroxaban
dc.subjectaspirin
dc.subjectrandomized trial
dc.titleRivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial
dc.typeArtículo

Files

Original bundle
Now showing 1 - 1 of 1
Thumbnail Image
Name:
Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source Design of the NAVIGATE ESUS randomized trial.pdf
Size:
350.82 KB
Format:
Adobe Portable Document Format
Description:
Texto completo
Download

Collections

Artículos Medicina y Ciencias de la Salud

Implementado por OpenGeek Services