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

被引：79

作者：

Hart, Robert G. ^{[1
]}

Sharma, Mukul ^{[1
]}

Mundl, Hardi ^{[2
]}

Shoamanesh, Ashkan ^{[1
]}

Kasner, Scott E. ^{[3
]}

Berkowitz, Scott D. ^{[4
]}

Pare, Guillaume ^{[1
]}

Kirsch, Bodo ^{[5
]}

Pogue, Janice ^{[6
]}

Pater, Calin ^{[7
]}

Peters, Gary ^{[8
]}

Davalos, Antoni ^{[9
]}

Lang, Wilfried ^{[10
]}

Wang, Yongjun ^{[11
]}

Wang, Yilong ^{[11
]}

Cunha, Luis ^{[12
]}

Eckstein, Jens ^{[13
]}

Tatlisumak, Turgut ^{[14
]}

Shamalov, Nikolay ^{[15
]}

Mikulik, Robert ^{[16
,17
]}

Lavados, Pablo ^{[18
]}

Hankey, Graeme J. ^{[19
]}

Czlonkowska, Anna ^{[20
]}

Toni, Danilo ^{[21
]}

Ameriso, Sebastian F. ^{[22
]}

Gagliardi, Rubens J. ^{[23
]}

Amarenco, Pierre ^{[24
]}

Bereczki, Daniel ^{[25
]}

Uchiyama, Shinichiro ^{[26
,27
]}

Lindgren, Arne ^{[28
]}

Endres, Matthias ^{[29
]}

Brouns, Raf ^{[30
]}

Yoon, Byung-Woo ^{[31
]}

Ntaios, George ^{[32
]}

Veltkamp, Roland ^{[33
]}

Muir, Keith W. ^{[34
]}

Ozturk, Serefnur ^{[35
]}

Arauz, Antonio ^{[36
]}

Bornstein, Natan ^{[37
]}

Bryer, Alan ^{[38
]}

O'Donnell, Martin J. ^{[39
]}

Weitz, Jeffrey ^{[40
]}

Peacock, Frank ^{[41
]}

Themeles, Ellison ^{[42
]}

Connolly, Stuart J. ^{[43
]}

机构：

[1] McMaster Univ, Hamilton Hlth Sci, Populat Hlth Res Inst, Dept Med Neurol, Hamilton, ON, Canada

[2] Bayer Pharma AG, Wuppertal, Germany

[3] Univ Penn, Dept Neurol, Philadelphia, PA 19104 USA

[4] Bayer Healthcare Pharmaceut, Parsippany, NJ USA

[5] Bayer Pharma AG, Berlin, Germany

[6] McMaster Univ, Populat Hlth Res Inst, Dept Med, Dept Clin Epidemiol & Biostat,Hamilton Hlth Sci, Hamilton, ON, Canada

[7] Bayer Vital, Leverkusen, Germany

[8] Janssen Res & Dev LLC, Spring House, PA USA

[9] Hosp Badalona Germans Trias & Pujol, Dept Neurosci, Barcelona, Spain

[10] Sigmund Freud Univ, Med Fac, Hosp St John God, Vienna, Austria

[11] Capital Med Univ, Beijing Tiantan Hosp, Dept Neurol, Beijing, Peoples R China

[12] Ctr Hosp & Univ Coimbra, Coimbra, Portugal

[13] Univ Spital Basel, Dept Innere Med, Basel, Switzerland

[14] Helsinki Univ Cent Hosp, Dept Neurol, Helsinki, Finland

[15] Pirogov Russian Natl Res Med Univ, Moscow, Russia

[16] St Annes Univ Hosp, Int Clin Res Ctr, Brno, Czech Republic

[17] St Annes Univ Hosp, Neurol Dept, Brno, Czech Republic

[18] Univ Chile, Univ Desarrollo, Clin Alemana Santiago, Santiago, Chile

[19] Univ Western Australia, Sch Med & Pharmacol, Sir Charles Gairdner Hosp, Perth, WA, Australia

[20] Med Univ Warsaw, Inst Psychiat & Neurol, Dept Neurol 2, Warsaw, Poland

[21] Sapienza Univ Rome, Dept Neurol & Psychiat, Rome, Italy

[22] FLENI, Inst Neurol Res, Buenos Aires, DF, Argentina

[23] Irmandade Santa Casa Misericordia Sao Paulo, Sao Paulo, Brazil

[24] Hop Xavier Bichat, Dept Neurol, Paris, France

[25] Semmelweis Univ, Dept Neurol, Budapest, Hungary

[26] Sanno Hosp, Tokyo, Japan

[27] Sanno Med Ctr, Tokyo, Japan

[28] Lund Univ, Skane Univ Hosp, Dept Neurol & Rehabil Med, Dept Clin Sci Neurol, Lund, Sweden

[29] Charite, Ctr Stroke Res Berlin, Klin & Hsch Ambulanz Neurol, Berlin, Germany

[30] Univ Ziekenhuis Brussel, Brussels, Belgium

[31] Seoul Natl Univ Hosp, Dept Neurol, Seoul, South Korea

[32] Univ Thessaly, Dept Med, Larisa, Greece

[33] Imperial Coll London, London, England

[34] Univ Glasgow, Queen Elizabeth Univ Hosp, Inst Neurosci & Psychol, Glasgow, Lanark, Scotland

[35] Selcuk Univ, Dept Neurol, Konya, Turkey

[36] Inst Nacl Neurol & Neurocirug, Mexico City, DF, Mexico

[37] Tel Aviv Med Ctr & Sch Med, Tel Aviv, Israel

[38] Univ Cape Town, Groote Schuur Hosp, Cape Town, South Africa

[39] Natl Univ Ireland, Galway, Ireland

[40] McMaster Univ, Thrombosis & Atherosclerosis Res Inst, Hamilton, ON, Canada

[41] Baylor Coll Med, Houston, TX 77030 USA

[42] Populat Hlth Res Inst, Hamilton, ON, Canada

[43] McMaster Univ, Populat Hlth Res Inst, Dept Med Cardiol, Hamilton Hlth Sci, Hamilton, ON, Canada

来源：

EUROPEAN STROKE JOURNAL | 2016年 / 1卷 / 03期

关键词：

Stroke; cryptogenic stroke; cerebral embolism; embolic stroke of undetermined source; stroke prevention; rivaroxaban; aspirin; randomized trial;

D O I：

10.1177/2396987316663049

中图分类号：

R74 [神经病学与精神病学];

学科分类号：

摘要：

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.

引用

页码：146 / 154

页数：9

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