Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial.
Abstract | BACKGROUND: 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 MRI-determined covert brain infarcts and (2) the biological underpinnings of embolic strokes of undetermined source using genomic and biomarker approaches. SUMMARY:
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Authors | Robert G Hart, Mukul Sharma, Hardi Mundl, Ashkan Shoamanesh, Scott E Kasner, Scott D Berkowitz, Guillaume Pare, Bodo Kirsch, Janice Pogue, Calin Pater, Gary Peters, Antoni Davalos, Wilfried Lang, Yongjun Wang, Yilong Wang, Luis Cunha, Jens Eckstein, Turgut Tatlisumak, Nikolay Shamalov, Robert Mikulik, Pablo Lavados, Graeme J Hankey, Anna Czlonkowska, Danilo Toni, Sebastian F Ameriso, Rubens J Gagliardi, Pierre Amarenco, Daniel Bereczki, Shinichiro Uchiyama, Arne Lindgren, Matthias Endres, Raf Brouns, Byung-Woo Yoon, George Ntaios, Roland Veltkamp, Keith W Muir, Serefnur Ozturk, Antonio Arauz, Natan Bornstein, Alan Bryer, Martin J O'Donnell, Jeffrey Weitz, Frank Peacock, Ellison Themeles, Stuart J Connolly |
Journal | European stroke journal
(Eur Stroke J)
Vol. 1
Issue 3
Pg. 146-154
(Sep 2016)
ISSN: 2396-9881 [Electronic] England |
PMID | 31008276
(Publication Type: Journal Article)
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