Amarenco, Pierre,

Ameriso, Sebastian F.,

Arauz, Antonio,

Bereczki, Daniel,

Berkowitz, Scott D.,

Bornstein, Natan,

Brouns, Raf,

Bryer, Alan

Connolly, Stuart J.,

Cunha, Luis,

Czlonkowska, Anna,

Davalos, Antoni,

Eckstein, Jens,

Endres, Matthias,

Gagliardi, Rubens J.,

Hankey, Graeme J.,

Hart, Robert G.,

Kasner, Scott E.,

Kirsch, Bodo,

Lang, Wilfried

Lavados, Pablo,

Lindgren, Arne,

Lund University.

Mikulik, Robert,

Muir, Keith W.,

Mundl, Hardi,

Ntaios, George,

Ozturk, Serefnur,

O’Donnell, Martin J.,

Pare, Guillaume,

Pater, Calin,

Peacock, Frank,

Peters, Gary,

Pogue, Janice,

Shamalov, Nikolay,

Sharma, Mukul,

Shoamanesh, Ashkan,

Tatlisumak, Turgut,

Themeles, Ellison,

Toni, Danilo,

Uchiyama, Shinichiro,

Veltkamp, Roland,

Wang, Yilong,

Weitz, Jeffrey

Yoon, Byung Woo,

Hart, Robert G.

Sharma,  Mukul

Mundl, Hardi

Shoamanesh, Ashkan

Kasner, Scott E.

Berkowitz, Scott D.

Pare, Guillaume

Kirsch, Bodo

Pogue, Janice

Pater, Calin

Peters, Gary

Davalos, Antoni

Wang, Yongjun

Wang, Yilong

Cunha, Luis

Eckstein, Jens

Tatlisumak, Turgut

Shamalov, Nikolay

Mikulik, Robert

Lavados, Pablo

Hankey, Graeme J.

Czlonkowska, Anna

Toni, Danilo

Ameriso, Sebastian F.

Gagliardi, Rubens J.

Amarenco, Pierre

Bereczki, Daniel

Uchiyama, Shinichiro

Lindgren, Arne

Endres, Matthias

Brouns, Raf

Yoon, Byung-Woo

Ntaios, George

Veltkamp, Roland

Muir, Keith W

Ozturk, Serefnur

Arauz, Antonio

Bornstein, Natan

O'Donnell, Martin J.

Weitzel, Jeffrey

Peacock, Frank

Themele, Ellison

Connolly, Stuart J.

Helsingin yliopiston digitaalinen arkisto

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

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

Hart, Robert

Sharma, Mukul

Kasner, Scott

Berkowitz, Scott

Hankey, Graeme

Ameriso, Sebastian

Gagliardi, Rubens

Muir, Keith

O’Donnell, Martin

Themeles, Ellison

Connolly, Stuart

Repositorio Universidad del Desarrollo (UDD)

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

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

Yoon, Byung Woo

Muir, Keith W.

O’Donnell, Martin J.

Lund University Publications

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

Enlighten

English

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

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

Swepub

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

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. </jats:sec

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

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Helsingin yliopiston digitaalinen arkisto

Repositorio Universidad del Desarrollo (UDD)

Lund University Publications

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