Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial-Reference-Cited by-同舟云学术

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

Published:2016-08-11 Issue:3 Volume:1 Page:146-154
ISSN:2396-9873
Container-title:European Stroke Journal
language:en
Short-container-title:European Stroke Journal

Author:

Hart Robert G¹,Sharma Mukul¹,Mundl Hardi²,Shoamanesh Ashkan¹,Kasner Scott E³,Berkowitz Scott D⁴,Pare Guillaume¹,Kirsch Bodo⁵,Pogue Janice⁶,Pater Calin⁷,Peters Gary⁸,Davalos Antoni⁹,Lang Wilfried¹⁰,Wang Yongjun¹¹,Wang Yilong¹¹,Cunha Luis¹²,Eckstein Jens¹³,Tatlisumak Turgut¹⁴,Shamalov Nikolay¹⁵,Mikulik Robert¹⁶,Lavados Pablo¹⁷,Hankey Graeme J¹⁸,Czlonkowska Anna¹⁹,Toni Danilo²⁰,Ameriso Sebastian F²¹,Gagliardi Rubens J²²,Amarenco Pierre²³,Bereczki Daniel²⁴,Uchiyama Shinichiro²⁵,Lindgren Arne²⁶,Endres Matthias²⁷,Brouns Raf²⁸,Yoon Byung-Woo²⁹,Ntaios George³⁰,Veltkamp Roland³¹,Muir Keith W³²,Ozturk Serefnur³³,Arauz Antonio³⁴,Bornstein Natan³⁵,Bryer Alan³⁶,O’Donnell Martin J³⁷,Weitz Jeffrey³⁸,Peacock Frank³⁹,Themeles Ellison⁴⁰,Connolly Stuart J⁴¹

Affiliation:

1. Department of Medicine (Neurology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

2. Bayer Pharma AG, Wuppertal, Germany

3. Department of Neurology, University of Pennsylvania, Philadelphia, USA

4. Bayer Healthcare Pharmaceuticals, Parsippany, USA

5. Bayer Pharma AG, Berlin, Germany

6. Department of Clinical Epidemiology and Biostatistics, Department of Medicine, Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

7. Bayer Vital, Leverkusen, Germany

8. Janssen Research and Development, LLC, Spring House, Pennsylvania, USA

9. Department of Neurosciences, Hospital Universitari Germans Trias i Pujol, Barcelona, Spain

10. Hospital St. John of God, Medical Faculty, Sigmund Freud University, Vienna, Austria

11. Department of Neurology, Beijing Tiantan Hospital, Capital Medical University, Beijing, China

12. Centro Hospitalar e Universitário de Coimbra, Coimbra, Portugal

13. Department of Innere Medizin, Universitätsspital Basel, Basel, Switzerland

14. Department of Neurology, Helsinki University Central Hospital, Helsinki, Finland

15. Pirogov Russian National Research Medical University, Moscow, Russia

16. International Clinical Research Center and Neurology Department, St. Anne’s University Hospital, Brno, Czech Republic

17. Clinica Alemana de Santiago, Universidad del Desarrollo, Universidad de Chile, Santiago, Chile

18. School of Medicine and Pharmacology, University of Western Australia, Sir Charles Gairdner Hospital, Perth, Australia

19. 2nd Department of Neurology, Institute of Psychiatry and Neurology, Medical University of Warsaw, Warsaw, Poland

20. Department of Neurology and Psychiatry, “Sapienza” University of Rome, Rome, Italy

21. Institute for Neurological Research, Fundacion para la Lucha contra las Enfermedades Neurologicas de la Infancia (FLENI), Buenos Aires, Argentina

22. Irmandade da Santa Casa de Misericórdia de São Paulo, Sao Paulo, Brazil

23. Department of Neurology, Bichat Hospital, Paris, France

24. Department of Neurology, Semmelweis University, Budapest, Hungary

25. Sanno Hospital and Sanno Medical Center, Tokyo, Japan

26. Department of Clinical Sciences (Neurology), Department of Neurology and Rehabilitation Medicine, Skane University Hospital, Lund University, Lund, Sweden

27. Klinik und Hochschulambulanz für Neurologie, Center for Stroke Research Berlin, Charité-Universitätsmedizin, Berlin, Germany

28. Universitair Ziekenhuis Brussel, Brussels, Belgium

29. Department of Neurology, Seoul National University Hospital, Seoul, Korea

30. Department of Medicine, University of Thessaly, Larissa, Greece

31. Imperial College London, London, UK

32. Institute of Neuroscience and Psychology, University of Glasgow, Queen Elizabeth University Hospital, Glasgow, UK

33. Department of Neurology, Selcuk University, Konya, Turkey

34. Instituto Nacional de Neurologia y Neurocirugia, Mexico D.F., Mexico

35. Tel-Aviv Medical Center, Tel-Aviv, Israel

36. Groote Schuur Hospital, University of Cape Town, Cape Town, South Africa

37. National University of Ireland, Galway, Ireland

38. Thrombosis and Atherosclerosis Research Institute, McMaster University, Hamilton, Canada

39. Baylor College of Medicine, Houston, USA

40. Population Health Research Institute, Hamilton, Canada

41. Department of Medicine (Cardiology), Population Health Research Institute, McMaster University, Hamilton Health Sciences, Hamilton, Canada

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.

Publisher

SAGE Publications

Subject

Cardiology and Cardiovascular Medicine,Neurology (clinical)

Link

http://journals.sagepub.com/doi/pdf/10.1177/2396987316663049

Reference30 articles.

1. Embolic strokes of undetermined source: the case for a new clinical construct

2. Incidence, outcome, risk factors, and long-term prognosis of cryptogenic transient ischaemic attack and ischaemic stroke: a population-based study

3. Infarcts of undetermined cause: The NINCDS stroke data bank

4. Embolic strokes of undetermined source: Prevalence and patient features in the ESUS Global Registry

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