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 Mikulik

doi:10.1177/2396987316663049

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

Journal

European Stroke Journal

ISSN

2396-9873

2396-9881

Date Issued

2016

Author(s)

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

Facultad de Medicina Clínica Alemana Universidad del Desarrollo

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

Type

Resource Types::text::journal::journal article

Scopus ID

2-s2.0-85016335318

DOI

10.1177/2396987316663049

URL

https://investigadores.udd.cl/handle/123456789/2760

URL Institutional Repository

http://hdl.handle.net/11447/1767

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.