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

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 MikulikPablo 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

Research output: Contribution to journalArticle

53 Citations (Scopus)

Abstract

Background: 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 MRI-determined 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.

Original languageEnglish
Pages (from-to)146-154
Number of pages9
JournalEuropean stroke journal
Volume1
Issue number3
DOIs
Publication statusPublished - Sep 2016

Cite this

Hart, R. G., Sharma, M., Mundl, H., Shoamanesh, A., Kasner, S. E., Berkowitz, S. D., 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., ... Connolly, S. J. (2016). Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. European stroke journal, 1(3), 146-154. https://doi.org/10.1177/2396987316663049