Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial
Date
2016
Type:
Artículo
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9
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ORCID:
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Publisher
Sage Publications
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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 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.
Description
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Citation
Hart 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
Keywords
Stroke, cryptogenic stroke, cerebral embolism, embolic stroke of undetermined source, stroke prevention, rivaroxaban, aspirin, randomized trial