Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS)
NCT ID: NCT02313909
Last Updated: 2019-01-09
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
7213 participants
INTERVENTIONAL
2014-12-23
2018-02-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Rivaroxaban
Rivaroxaban 15 mg orally once daily
Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily, orally, tablet
Rivaroxaban-Placebo
Matching placebo, once daily, orally, tablet
Aspirin
Aspirin 100 mg orally once daily
Acetylsalicylic acid (Aspirin, BAY1019036)
100 mg, once daily, orally, tablet
Aspirin-Placebo
Matching placebo, once daily, orally, tablet
Interventions
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Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily, orally, tablet
Acetylsalicylic acid (Aspirin, BAY1019036)
100 mg, once daily, orally, tablet
Rivaroxaban-Placebo
Matching placebo, once daily, orally, tablet
Aspirin-Placebo
Matching placebo, once daily, orally, tablet
Eligibility Criteria
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Inclusion Criteria
* Recent ischemic stroke (including transient ischemic attack with positive neuroimaging) visualized by brain imaging that is not lacunar, and
* Absence of cervical carotid atherosclerotic stenosis\> 50% or occlusion, and
* No atrial fibrillation after ≥ 24-hour cardiac rhythm monitoring, and
* No intra-cardiac thrombus on either transesophageal or transthoracic echocardiography, and
* No other specific cause of stroke (for example, arteritis, dissection, migraine/vasospasm, drug abuse)
Exclusion Criteria
* Indication for chronic anticoagulation or antiplatelet therapy
* Estimated glomerular filtration rate (eGFR) \< 30 mL/min/1.73 m\^2
50 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Population Health Research Institute
OTHER
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Tucson, Arizona, United States
Long Beach, California, United States
Stanford, California, United States
Torrance, California, United States
New Haven, Connecticut, United States
Gainesville, Florida, United States
Joliet, Illinois, United States
Iowa City, Iowa, United States
Lexington, Kentucky, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Ann Arbor, Michigan, United States
Mount Clemens, Michigan, United States
New Brunswick, New Jersey, United States
Buffalo, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Nashville, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Temple, Texas, United States
Salt Lake City, Utah, United States
Seattle, Washington, United States
Banfield, Buenos Aires, Argentina
Ciudad Auton. de Buenos Aires, Buenos Aires, Argentina
Mar del Plata, Buenos Aires, Argentina
San Martín, Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina
Rosario, Santa Fe Province, Argentina
Rosario, Santa Fe Province, Argentina
Ciudad Auton. de Buenos Aires, , Argentina
Córdoba, , Argentina
Santa Fe, , Argentina
Camperdown, New South Wales, Australia
Waratah, New South Wales, Australia
Brisbane, Queensland, Australia
Southport, Queensland, Australia
Launceston, Tasmania, Australia
Clayton, Victoria, Australia
Footscray, Victoria, Australia
Murdoch, Western Australia, Australia
Elizabeth Vale, , Australia
Nedlands, , Australia
Klagenfurt, Carinthia, Austria
Villach, Carinthia, Austria
Bad Pirawarth, Lower Austria, Austria
Sankt Pölten, Lower Austria, Austria
Feldbach, Styria, Austria
Vöcklabruck, Upper Austria, Austria
Feldkirch, Vorarlberg, Austria
Salzburg, , Austria
Vienna, , Austria
Vienna, , Austria
Bruges, West-Vlaanderen, Belgium
Antwerp, , Belgium
Brussels, , Belgium
Bruxelles - Brussel, , Belgium
Dendermonde, , Belgium
Edegem, , Belgium
Hasselt, , Belgium
Salvador, Estado de Bahia, Brazil
Belo Horizonte, Minas Gerais, Brazil
Belo Horizonte, Minas Gerais, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
Joinville, Santa Catarina, Brazil
Botucatu, São Paulo, Brazil
Campinas, São Paulo, Brazil
Matão, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
Ribeirão Preto, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Rio de Janeiro, , Brazil
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
Edmonton, Alberta, Canada
Lethbridge, Alberta, Canada
Vancouver, British Columbia, Canada
Victoria, British Columbia, Canada
Brandon, Manitoba, Canada
Saint John, New Brunswick, Canada
Halifax, Nova Scotia, Canada
Burlington, Ontario, Canada
Hamilton, Ontario, Canada
Kingston, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Ottawa, Ontario, Canada
Thunder Bay, Ontario, Canada
Toronto, Ontario, Canada
Chicoutimi, Quebec, Canada
Montreal, Quebec, Canada
Montreal, Quebec, Canada
Saint-Jérôme, Quebec, Canada
Québec, , Canada
Los Ángeles, Bío-Bío, Chile
Osorno, Los Lagos Region, Chile
Port Montt, Los Lagos Region, Chile
Valdivia, Los Lagos Region, Chile
Viña del Mar, Región de Valparaíso, Chile
Santiago, , Chile
Santiago, , Chile
Viña del Mar, , Chile
Fuzhou, Fujian, China
Fuzhou, Fujian, China
Lanzhou, Gansu, China
Foshan, Guangdong, China
Guangzhou, Guangdong, China
Haikou, Hainan, China
Shijiazhuang, Hebei, China
Harbin, Heilongjiang, China
Zhengzhou, Henan, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Wuhan, Hubei, China
Changsha, Hunan, China
Baotou, Inner Mongolia, China
Nantong, Jiangsu, China
Nanchang, Jiangxi, China
Changchun, Jilin, China
Shenyang, Liaoning, China
Qingdao, Shandong, China
Yantai, Shandong, China
Baoji, Shanxi, China
Xi’an, Shanxi, China
Kunming, Yunnan, China
Hangzhou, Zhejiang, China
Taizhou, Zhejiang, China
Wenzhou, Zhejiang, China
Beijing, , China
Beijing, , China
Chongqing, , China
Guangzhou, , China
Shanghai, , China
Tianjin, , China
Tianjin, , China
Blansko, , Czechia
Brno, , Czechia
Brno, , Czechia
Hradec Králové, , Czechia
Jihlava, , Czechia
Olomouc, , Czechia
Ostrava Vitkovice, , Czechia
Ostrava-Poruba, , Czechia
Prague, , Czechia
Prague, , Czechia
Vyškov, , Czechia
Aalborg, , Denmark
Aarhus C, , Denmark
Copenhagen, , Denmark
Glostrup Municipality, , Denmark
Herlev, , Denmark
Hillerød, , Denmark
Helsinki, , Finland
Lappeenranta, , Finland
OYS, , Finland
Sairaalamäki, , Finland
Tampere, , Finland
Turku, , Finland
Vaasa, , Finland
Antony, , France
Bordeaux, , France
Brest, , France
Caen, , France
Dijon, , France
Le Chesnay, , France
Limoges, , France
Nantes, , France
Nîmes, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Paris, , France
Saint-Priest-en-Jarez, , France
Strasbourg, , France
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Mannheim, Baden-Wurttemberg, Germany
München, Bavaria, Germany
Regensburg, Bavaria, Germany
Würzburg, Bavaria, Germany
Hanover, Lower Saxony, Germany
Düsseldorf, North Rhine-Westphalia, Germany
Meerbusch, North Rhine-Westphalia, Germany
Wuppertal, North Rhine-Westphalia, Germany
Dresden, Saxony, Germany
Dresden, Saxony, Germany
Markkleeberg, Saxony, Germany
Wermsdorf, Saxony, Germany
Halle, Saxony-Anhalt, Germany
Altenburg, Thuringia, Germany
Berlin, , Germany
Hamburg, , Germany
Athens, , Greece
Athens, , Greece
Ioannina, , Greece
Larissa, , Greece
Thessaloniki, , Greece
Budapest, , Hungary
Budapest, , Hungary
Budapest, , Hungary
Debrecen, , Hungary
Eger, , Hungary
Győr, , Hungary
Kistarcsa, , Hungary
Miskolc, , Hungary
Nagykanizsa, , Hungary
Nyíregyháza, , Hungary
Sopron, , Hungary
Szeged, , Hungary
Zalaegerszeg, , Hungary
Dublin, , Ireland
Galway, , Ireland
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Ramat Gan, , Israel
Tel Aviv, , Israel
L’Aquila, Abruzzo, Italy
Vibo Valentia, Calabria, Italy
Parma, Emilia-Romagna, Italy
Trieste, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Rome, Lazio, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Milan, Lombardy, Italy
Pavia, Lombardy, Italy
Isernia, Molise, Italy
Cagliari, Sardinia, Italy
Ancona, The Marches, Italy
Perugia, Umbria, Italy
Perugia, Umbria, Italy
Perugia, Umbria, Italy
Verona, Veneto, Italy
Verona, Veneto, Italy
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Nagoya, Aichi-ken, Japan
Okazaki, Aichi-ken, Japan
Seto, Aichi-ken, Japan
Toyota, Aichi-ken, Japan
Kitakyushu, Fukuoka, Japan
Kitakyushu, Fukuoka, Japan
Kōriyama, Fukushima, Japan
Fukuyama, Hiroshima, Japan
Asahikawa, Hokkaido, Japan
Hakodate, Hokkaido, Japan
Kushiro, Hokkaido, Japan
Kobe, Hyōgo, Japan
Kobe, Hyōgo, Japan
Kobe, Hyōgo, Japan
Nishinomiya, Hyōgo, Japan
Isehara, Kanagawa, Japan
Kawasaki, Kanagawa, Japan
Sendai, Miyagi, Japan
Sasebo, Nagasaki, Japan
Tenri, Nara, Japan
Kurashiki, Okayama-ken, Japan
Matsubara, Osaka, Japan
Sakai, Osaka, Japan
Suita, Osaka, Japan
Hidaka, Saitama, Japan
Bunkyo-ku, Tokyo, Japan
Hachiōji, Tokyo, Japan
Kodaira, Tokyo, Japan
Musashino, Tokyo, Japan
Shinjuku-ku, Tokyo, Japan
Sumida-ku, Tokyo, Japan
Fukuoka, , Japan
Fukuoka, , Japan
Fukuoka, , Japan
Hiroshima, , Japan
Kakogawa, , Japan
Kochi, , Japan
Kyoto, , Japan
Kyoto, , Japan
Kyoto, , Japan
Niigata, , Japan
Okayama, , Japan
Gustavo Adolfo Madero, Mexico City, Mexico
México, D.F., Mexico City, Mexico
Morelia, Michoacán, Mexico
México D.F., México, Mexico
Monterrey, Nuevo León, Mexico
Mérida, Yucatán, Mexico
Aguascalientes, , Mexico
México D.F., , Mexico
Bialystok, , Poland
Chełm, , Poland
Gdansk, , Poland
Gdansk, , Poland
Gmina Końskie, , Poland
Katowice, , Poland
Lodz, , Poland
Lodz, , Poland
Olsztyn, , Poland
Sandomierz, , Poland
Siedlce, , Poland
Skarżysko-Kamienna, , Poland
Warsaw, , Poland
Warsaw, , Poland
Warsaw, , Poland
Vilanova de Gaia, Porto District, Portugal
Almada, , Portugal
Amadora, , Portugal
Coimbra, , Portugal
Lisbon, , Portugal
Porto, , Portugal
Porto, , Portugal
Vila Franca de Xira, , Portugal
Chelyabinsk, , Russia
Kaluga, , Russia
Kazan', , Russia
Krasnoyarsk, , Russia
Moscow, , Russia
Moscow, , Russia
Nizhny Novgorod, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Saint Petersburg, , Russia
Tomsk, , Russia
Ulyanovsk, , Russia
Volgograd, , Russia
Yaroslavl, , Russia
Yekaterinburg, , Russia
Yekaterinburg, , Russia
Cape Town, Western Cape, South Africa
Somerset West, Western Cape, South Africa
Durban, , South Africa
Donggu, Gwangju Gwang''yeogsi, South Korea
Anyang-si, Gyeonggido, South Korea
Goyang, Gyeonggido, South Korea
Seongnam-si, Gyeonggido, South Korea
Seoul, Seoul Teugbyeolsi, South Korea
Busan, , South Korea
Daegu, , South Korea
Daegu, , South Korea
Incheon, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Seoul, , South Korea
Santiago de Compostela, A Coruña, Spain
Badalona, Barcelona, Spain
L'Hospitalet de Llobregat, Barcelona, Spain
Sant Joan Despí, Barcelona, Spain
Castellon, Castellón, Spain
El Palmar (Murcia), Murcia, Spain
A Coruña, , Spain
Badajoz, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Bilbao, , Spain
Cáceres, , Spain
Girona, , Spain
Granada, , Spain
León, , Spain
Lleida, , Spain
Madrid, , Spain
Madrid, , Spain
Madrid, , Spain
Seville, , Spain
Seville, , Spain
Valencia, , Spain
Valladolid, , Spain
Zaragoza, , Spain
Gothenburg, , Sweden
Hässleholm, , Sweden
Lund, , Sweden
Malmo, , Sweden
Umeå, , Sweden
Aarau, Canton of Aargau, Switzerland
Basel, Canton of Basel-City, Switzerland
Lugano, Canton Ticino, Switzerland
Baden, , Switzerland
Bern, , Switzerland
Fribourg, , Switzerland
Geneva, , Switzerland
Zurich, , Switzerland
Ankara, , Turkey (Türkiye)
Ankara, , Turkey (Türkiye)
Antakya, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Istanbul, , Turkey (Türkiye)
Kahramanmaraş, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
Konya, , Turkey (Türkiye)
High Wycombe, Buckinghamshire, United Kingdom
Milton Keynes, Buckinghamshire, United Kingdom
Cambridge, Cambridgeshire, United Kingdom
Exeter, Devon, United Kingdom
Colchester, Essex, United Kingdom
Westcliff-on-Sea, Essex, United Kingdom
Gloucester, Gloucestershire, United Kingdom
Watford, Hertfordshire, United Kingdom
Ashford, Kent, United Kingdom
Margate, Kent, United Kingdom
Leicester, Leicestershire, United Kingdom
Boston, Lincolnshire, United Kingdom
Harrow, London, United Kingdom
Great Yarmouth, Norfolk, United Kingdom
Taunton, Somerset, United Kingdom
Yeovil, Somerset, United Kingdom
Sheffield, South Yorkshire, United Kingdom
Stoke-on-Trent, Staffordshire, United Kingdom
Glasgow, Stratchclyde, United Kingdom
Gateshead, Tyne and Wear, United Kingdom
Sunderland, Tyne and Wear, United Kingdom
Wolverhampton, West Midlands, United Kingdom
Leeds, West Yorkshire, United Kingdom
Salisbury, Wiltshire, United Kingdom
Aberdeen, , United Kingdom
Durham, , United Kingdom
Edinburgh, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Luton, , United Kingdom
Norwich, , United Kingdom
Countries
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References
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Hart RG, Sharma M, Mundl H, Kasner SE, Bangdiwala SI, Berkowitz SD, Swaminathan B, Lavados P, Wang Y, Wang Y, Davalos A, Shamalov N, Mikulik R, Cunha L, Lindgren A, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi RJ, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni D, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, Endres M, Muir KW, Bornstein N, Ozturk S, O'Donnell MJ, De Vries Basson MM, Pare G, Pater C, Kirsch B, Sheridan P, Peters G, Weitz JI, Peacock WF, Shoamanesh A, Benavente OR, Joyner C, Themeles E, Connolly SJ; NAVIGATE ESUS Investigators. Rivaroxaban for Stroke Prevention after Embolic Stroke of Undetermined Source. N Engl J Med. 2018 Jun 7;378(23):2191-2201. doi: 10.1056/NEJMoa1802686. Epub 2018 May 16.
Kasner SE, Lavados P, Sharma M, Wang Y, Wang Y, Davalos A, Shamalov N, Cunha L, Lindgren A, Mikulik R, Arauz A, Lang W, Czlonkowska A, Eckstein J, Gagliardi R, Amarenco P, Ameriso SF, Tatlisumak T, Veltkamp R, Hankey GJ, Toni DS, Bereczki D, Uchiyama S, Ntaios G, Yoon BW, Brouns R, DeVries Basson MM, Endres M, Muir K, Bornstein N, Ozturk S, O'Donnell M, Mundl H, Pater C, Weitz J, Peacock WF, Swaminathan B, Kirsch B, Berkowitz SD, Peters G, Pare G, Themeles E, Shoamanesh A, Connolly SJ, Hart RG; NAVIGATE ESUS Steering Committee and Investigators. Characterization of Patients with Embolic Strokes of Undetermined Source in the NAVIGATE ESUS Randomized Trial. J Stroke Cerebrovasc Dis. 2018 Jun;27(6):1673-1682. doi: 10.1016/j.jstrokecerebrovasdis.2018.01.027. Epub 2018 Mar 7.
Hart RG, Sharma M, Mundl H, Shoamanesh A, Kasner SE, Berkowitz SD, Pare G, Kirsch B, Pogue J, Pater C, Peters G, Davalos A, Lang W, Wang Y, Wang Y, Cunha L, Eckstein J, Tatlisumak T, Shamalov N, Mikulik R, Lavados P, Hankey GJ, Czlonkowska A, Toni D, Ameriso SF, Gagliardi RJ, Amarenco P, Bereczki D, Uchiyama S, Lindgren A, Endres M, Brouns R, Yoon BW, Ntaios G, Veltkamp R, Muir KW, Ozturk S, Arauz A, Bornstein N, Bryer A, O'Donnell MJ, Weitz J, Peacock F, Themeles E, Connolly SJ. Rivaroxaban for secondary stroke prevention in patients with embolic strokes of undetermined source: Design of the NAVIGATE ESUS randomized trial. Eur Stroke J. 2016 Sep;1(3):146-154. doi: 10.1177/2396987316663049. Epub 2016 Aug 3.
Lee SF, Whiteley W, Bosch J, Sherlock L, Cukierman-Yaffe T, O'Donnell M, Eikelboom JW, Gerstein HC, Bangdiwala SI, Muniz-Terrera G. Improving analysis of cognitive outcomes in cardiovascular trials using different statistical approaches. Trials. 2024 Oct 2;25(1):644. doi: 10.1186/s13063-024-08482-2.
Sharma M, Smith EE, Pearce LA, Perera KS, Kasner SE, Yoon BW, Ameriso SF, Puig J, Damgaard D, Fiebach JB, Muir KW, Veltkamp RC, Toni DS, Shamalov N, Gagliardi RJ, Mikulik R, Engelter ST, Bereczki D, O'Donnell MJ, Saad F, Shoamanesh A, Berkowitz SD, Mundl H, Hart RG; NAVIGATE ESUS MRI Substudy Investigators. Rivaroxaban versus aspirin for prevention of covert brain infarcts in patients with embolic stroke of undetermined source: NAVIGATE ESUS MRI substudy. Int J Stroke. 2022 Aug;17(7):799-805. doi: 10.1177/17474930211058012. Epub 2021 Nov 18.
Merkler AE, Pearce LA, Kasner SE, Shoamanesh A, Birnbaum LA, Kamel H, Sheth KN, Sharma R. Left Ventricular Dysfunction Among Patients With Embolic Stroke of Undetermined Source and the Effect of Rivaroxaban vs Aspirin: A Subgroup Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Dec 1;78(12):1454-1460. doi: 10.1001/jamaneurol.2021.3828.
Sharma M, Smith EE, Pearce LA, Shoamanesh A, Perera KS, Coutts SB, Damgaard D, Ameriso SF, Rha JH, Modrau B, Yoon BW, Romano M, Messe SR, Barlinn J, Lambeck J, Saad F, Berkowitz SD, Mundl H, Connolly SJ, Hart RG; NAVIGATE ESUS MIND MRI Substudy Investigators. Frequency and Patterns of Brain Infarction in Patients With Embolic Stroke of Undetermined Source: NAVIGATE ESUS Trial. Stroke. 2022 Jan;53(1):45-52. doi: 10.1161/STROKEAHA.120.032976. Epub 2021 Sep 20.
Shoamanesh A, Hart RG, Connolly SJ, Kasner SE, Smith EE, Marti-Fabregas J, Liu YY, Uchiyama S, Mikulik R, Veltkamp R, O'Donnell MJ, Ntaios G, Muir KW, Field TS, Santo GC, Olavarria V, Mundl H, Lutsep H, Berkowitz SD, Sharma M. Microbleeds and the Effect of Anticoagulation in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Randomized Clinical Trial. JAMA Neurol. 2021 Jan 1;78(1):11-20. doi: 10.1001/jamaneurol.2020.3836.
Scheitz JF, Pare G, Pearce LA, Mundl H, Peacock WF, Czlonkowska A, Sharma M, Nolte CH, Shoamanesh A, Berkowitz SD, Krahn T, Endres M; NAVIGATE-ESUS Biomarker Working Group. High-Sensitivity Cardiac Troponin T for Risk Stratification in Patients With Embolic Stroke of Undetermined Source. Stroke. 2020 Aug;51(8):2386-2394. doi: 10.1161/STROKEAHA.120.029628. Epub 2020 Jul 9.
Veltkamp R, Pearce LA, Korompoki E, Sharma M, Kasner SE, Toni D, Ameriso SF, Mundl H, Tatlisumak T, Hankey GJ, Lindgren A, Berkowitz SD, Arauz A, Ozturk S, Muir KW, Chamorro A, Perera K, Shuaib A, Rudilosso S, Shoamanesh A, Connolly SJ, Hart RG. Characteristics of Recurrent Ischemic Stroke After Embolic Stroke of Undetermined Source: Secondary Analysis of a Randomized Clinical Trial. JAMA Neurol. 2020 Oct 1;77(10):1233-1240. doi: 10.1001/jamaneurol.2020.1995.
Mikulik R, Eckstein J, Pearce LA, Mundl H, Rudilosso S, Olavarria VV, Shoamanesh A, Chamorro A, Marti-Fabregas J, Veltkamp R, Ozturk S, Tatlisumak T, Peacock WF, Berkowitz SD, Connolly SJ, Hart RG. Frequency and Predictors of Major Bleeding in Patients With Embolic Strokes of Undetermined Source: NAVIGATE-ESUS Trial. Stroke. 2020 Jul;51(7):2139-2147. doi: 10.1161/STROKEAHA.119.027995. Epub 2020 Jun 10.
Ntaios G, Pearce LA, Veltkamp R, Sharma M, Kasner SE, Korompoki E, Milionis H, Mundl H, Berkowitz SD, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Potential Embolic Sources and Outcomes in Embolic Stroke of Undetermined Source in the NAVIGATE-ESUS Trial. Stroke. 2020 Jun;51(6):1797-1804. doi: 10.1161/STROKEAHA.119.028669. Epub 2020 Apr 16.
Martinez-Majander N, Ntaios G, Liu YY, Ylikotila P, Joensuu H, Saarinen J, Perera KS, Marti-Fabregas J, Chamorro A, Rudilosso S, Prats-Sanchez L, Berkowitz SD, Mundl H, Themeles E, Tiainen M, Demchuk A, Kasner SE, Hart RG, Tatlisumak T; NAVIGATE ESUS investigators. Rivaroxaban versus aspirin for secondary prevention of ischaemic stroke in patients with cancer: a subgroup analysis of the NAVIGATE ESUS randomized trial. Eur J Neurol. 2020 May;27(5):841-848. doi: 10.1111/ene.14172. Epub 2020 Mar 11.
Ntaios G, Pearce LA, Meseguer E, Endres M, Amarenco P, Ozturk S, Lang W, Bornstein NM, Molina CA, Pagola J, Mundl H, Berkowitz SD, Liu YY, Sen S, Connolly SJ, Hart RG. Aortic Arch Atherosclerosis in Patients With Embolic Stroke of Undetermined Source: An Exploratory Analysis of the NAVIGATE ESUS Trial. Stroke. 2019 Nov;50(11):3184-3190. doi: 10.1161/STROKEAHA.119.025813. Epub 2019 Sep 17.
Ntaios G, Swaminathan B, Berkowitz SD, Gagliardi RJ, Lang W, Siegler JE, Lavados P, Mundl H, Bornstein N, Meseguer E, Amarenco P, Cucchiara B, Camps-Renom P, Makaritsis K, Korompoki E, Papavasileiou V, Marti-Fabregas J, Milionis H, Vemmos K, Connolly SJ, Hart RG; NAVIGATE ESUS Investigators. Efficacy and Safety of Rivaroxaban Versus Aspirin in Embolic Stroke of Undetermined Source and Carotid Atherosclerosis. Stroke. 2019 Sep;50(9):2477-2485. doi: 10.1161/STROKEAHA.119.025168. Epub 2019 Aug 12.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
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Other Identifiers
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2013-000768-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
16573
Identifier Type: -
Identifier Source: org_study_id
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