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

Hart, Robert G. ; Sharma, Mukul ; Mundl, Hardi ; Shoamanesh, Ashkan ; Kasner, Scott E. ; Berkowitz, Scott D. ; Pare, Guillaume ; Kirsch, Bodo ; Pogue, Janice and Pater, Calin , et al. (2016) In European Stroke Journal 1(3). p.146-154
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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
aspirin, cerebral embolism, cryptogenic stroke, embolic stroke of undetermined source, randomized trial, rivaroxaban, Stroke, stroke prevention
in
European Stroke Journal
volume
1
issue
3
pages
9 pages
publisher
SAGE Publications
external identifiers
  • scopus:85016335318
ISSN
2396-9873
DOI
10.1177/2396987316663049
language
English
LU publication?
yes
id
c80faa96-af0f-4523-9217-8bd25f85c536
date added to LUP
2019-06-28 13:38:21
date last changed
2021-02-24 14:14:08
@article{c80faa96-af0f-4523-9217-8bd25f85c536,
  abstract     = {<p>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.</p>},
  author       = {Hart, Robert G. and Sharma, Mukul and Mundl, Hardi and Shoamanesh, Ashkan and Kasner, Scott E. and Berkowitz, Scott D. and Pare, Guillaume and Kirsch, Bodo and Pogue, Janice and Pater, Calin and Peters, Gary and Davalos, Antoni and Lang, Wilfried and Wang, Yilong and Wang, Yilong and Cunha, Luis and Eckstein, Jens and Tatlisumak, Turgut and Shamalov, Nikolay and Mikulik, Robert and Lavados, Pablo and Hankey, Graeme J. and Czlonkowska, Anna and Toni, Danilo and Ameriso, Sebastian F. and Gagliardi, Rubens J. and Amarenco, Pierre and Bereczki, Daniel and Uchiyama, Shinichiro and Lindgren, Arne and Endres, Matthias and Brouns, Raf and Yoon, Byung Woo and Ntaios, George and Veltkamp, Roland and Muir, Keith W. and Ozturk, Serefnur and Arauz, Antonio and Bornstein, Natan and Bryer, Alan and O’Donnell, Martin J. and Weitz, Jeffrey and Peacock, Frank and Themeles, Ellison and Connolly, Stuart J.},
  issn         = {2396-9873},
  language     = {eng},
  number       = {3},
  pages        = {146--154},
  publisher    = {SAGE Publications},
  series       = {European Stroke Journal},
  title        = {Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source : Design of the NAVIGATE ESUS randomized trial},
  url          = {http://dx.doi.org/10.1177/2396987316663049},
  doi          = {10.1177/2396987316663049},
  volume       = {1},
  year         = {2016},
}