Rivaroxaban Versus Aspirin in Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With Recent Embolic Stroke of Undetermined Source (ESUS) (NAVIGATE ESUS)

December 20, 2018 updated by: Bayer

Multicenter, Randomized, Double-blind, Double-dummy, Active-comparator, Event-driven, Superiority Phase III Study of Secondary Prevention of Stroke and Prevention of Systemic Embolism in Patients With a Recent Embolic Stroke of Undetermined Source (ESUS), Comparing Rivaroxaban 15 mg Once Daily With Aspirin 100 mg

This is a study in patients who recently had a brain attack (stroke) and in whom no clear cause of the stroke could be identified. These strokes are likely due to a blood clot and therefore, can be called embolic stroke of undetermined source. The abbreviation is ESUS. The study will compare 2 blood thinners. Patients will be randomly assigned to either Rivaroxaban 15 mg or Aspirin 100 mg and the study is intended to show, if patients given rivaroxaban have fewer blood clots in the brain (stroke) or in other blood vessels.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7213

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Ciudad Auton. de Buenos Aires, Argentina, C1425DND
      • Córdoba, Argentina, X5000JHQ
      • Santa Fe, Argentina, 3000
    • Buenos Aires
      • Banfield, Buenos Aires, Argentina, 1828
      • Ciudad Auton. de Buenos Aires, Buenos Aires, Argentina, C1405CNF
      • Mar del Plata, Buenos Aires, Argentina, B7602CBM
      • San Martín, Buenos Aires, Argentina, 1650
    • Ciudad Auton. De Buenos Aires
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, 1078
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, 1428
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1039AAO
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1221 ADC
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1431FWO
      • Buenos Aires, Ciudad Auton. De Buenos Aires, Argentina, C1437JCP
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
      • Rosario, Santa Fe, Argentina
  • Australia
      • Elizabeth Vale, Australia, 5112
      • Nedlands, Australia, 6009
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
      • Waratah, New South Wales, Australia, 2298
    • Queensland
      • Brisbane, Queensland, Australia, 4029
      • Southport, Queensland, Australia, 4215
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
    • Victoria
      • Clayton, Victoria, Australia, 3168
      • Footscray, Victoria, Australia, 3011
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
  • Austria
      • Salzburg, Austria, 5020
      • Wien, Austria, 1090
      • Wien, Austria, 1020
    • Kärnten
      • Klagenfurt, Kärnten, Austria, 9020
      • Villach, Kärnten, Austria, 9500
    • Niederösterreich
      • Bad Pirawarth, Niederösterreich, Austria, 2222
      • St. Pölten, Niederösterreich, Austria, 3100
    • Oberösterreich
      • Vöcklabruck, Oberösterreich, Austria, 4840
    • Steiermark
      • Feldbach, Steiermark, Austria, 8330
    • Vorarlberg
      • Feldkirch, Vorarlberg, Austria, 6807
  • Belgium
      • Antwerpen, Belgium, 2020
      • Brussel, Belgium, 1090
      • Bruxelles - Brussel, Belgium, 1070
      • Dendermonde, Belgium, 9200
      • Edegem, Belgium, 2650
      • Hasselt, Belgium, 3500
    • West-Vlaanderen
      • Brugge, West-Vlaanderen, Belgium, 8310
  • Brazil
      • Rio de Janeiro, Brazil, 22281-100
    • Bahia
      • Salvador, Bahia, Brazil, 41253-190
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30150-221
      • Belo Horizonte, Minas Gerais, Brazil, 30130-100
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-001
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90110-270
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89202-165
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618 970
      • Campinas, Sao Paulo, Brazil, 13081-000
      • Matão, Sao Paulo, Brazil, 15990-060
      • Ribeirão Preto, Sao Paulo, Brazil, 14015-130
      • Ribeirão Preto, Sao Paulo, Brazil, 14048-900
      • São Paulo, Sao Paulo, Brazil, 01228-000
      • São Paulo, Sao Paulo, Brazil, 08270-070
  • Canada
      • Quebec, Canada, G1J 1Z4
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
      • Edmonton, Alberta, Canada, T6G 2B7
      • Edmonton, Alberta, Canada, T6L 5X8
      • Lethbridge, Alberta, Canada, T1K 0C9
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Victoria, British Columbia, Canada, V8R 1J8
    • Manitoba
      • Brandon, Manitoba, Canada, R7A 2B3
    • New Brunswick
      • Saint John, New Brunswick, Canada, E2L 4L2
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 2Y5
    • Ontario
      • Burlington, Ontario, Canada, L7M 4Y1
      • Hamilton, Ontario, Canada, L8L 2X2
      • Kingston, Ontario, Canada, K7L 2V7
      • London, Ontario, Canada, N6A 5A5
      • London, Ontario, Canada, N6G 2V4
      • Mississauga, Ontario, Canada, L5B 2V2
      • Ottawa, Ontario, Canada, K1Y 4E9
      • Thunder Bay, Ontario, Canada, P7K 0A4
      • Toronto, Ontario, Canada, M4N 3M5
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
      • Montreal, Quebec, Canada, H2L 4M1
      • Montreal, Quebec, Canada, H3G 1A4
      • St. Jerome, Quebec, Canada, J7Z 5T3
  • Chile
      • Santiago, Chile, 7650567
      • Santiago, Chile, 8420524
      • Viña del Mar, Chile
    • Bío-Bío
      • Los Angeles, Bío-Bío, Chile
    • Los Lagos
      • Osorno, Los Lagos, Chile
      • Puerto Montt, Los Lagos, Chile, 5506667
      • Valdivia, Los Lagos, Chile
    • Valparaíso
      • Viña del Mar, Valparaíso, Chile
  • China
      • Beijing, China, 100050
      • Beijing, China, 100730
      • Chongqing, China
      • Guangzhou, China
      • Shanghai, China, 200032
      • Tianjin, China, 300000
      • Tianjin, China, 300052
    • Fujian
      • Fuzhou, Fujian, China, 350001
      • Fuzhou, Fujian, China, 350005
    • Gansu
      • Lanzhou, Gansu, China, 730000
    • Guangdong
      • Foshan, Guangdong, China, 528000
      • Guangzhou, Guangdong, China, 510080
    • Hainan
      • Haikou, Hainan, China, 570311
    • Hebei
      • Shijiazhuang, Hebei, China, 050000
    • Heilongjiang
      • Harbin, Heilongjiang, China
    • Henan
      • Zhengzhou, Henan, China, 450052
    • Hubei
      • Wuhan, Hubei, China, 430014
      • Wuhan, Hubei, China, 430034
      • Wuhan, Hubei, China, 430060
    • Hunan
      • Changsha, Hunan, China, 410008
    • Inner Mongolia
      • Baotou, Inner Mongolia, China, 014010
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
    • Jilin
      • Changchun, Jilin, China, 130021
    • Liaoning
      • Shenyang, Liaoning, China, 110016
    • Shandong
      • Qingdao, Shandong, China, 266003
      • Yantai, Shandong, China, 264000
    • Shanxi
      • Baoji, Shanxi, China, 721008
      • Xi'an, Shanxi, China, 710038
    • Yunnan
      • Kunming, Yunnan, China, 650032
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
      • Taizhou, Zhejiang, China, 317000
      • Wenzhou, Zhejiang, China, 325000
  • Czechia
      • Blansko, Czechia, 67801
      • Brno, Czechia, 625 00
      • Brno, Czechia, 656 91
      • Hradec Kralove, Czechia, 500 05
      • Jihlava, Czechia, 58633
      • Olomouc, Czechia, 775 20
      • Ostrava Vitkovice, Czechia
      • Ostrava-Poruba, Czechia, 708 52
      • Praha 2, Czechia, 128 21
      • Praha 3, Czechia, 10034
      • Vyskov, Czechia, 682 01
  • Denmark
      • Aalborg, Denmark, 9100
      • Aarhus C, Denmark, 8000
      • Copenhagen, Denmark, 2400
      • Glostrup, Denmark, 2600
      • Herlev, Denmark, 2730
      • Hillerød, Denmark, 3400
  • Finland
      • Helsinki, Finland, 00029
      • Lappeenranta, Finland, FIN-53130
      • OYS, Finland, 90029
      • Sairaalamäki, Finland, 45750
      • Tampere, Finland, FIN-33520
      • Turku, Finland, 20520
      • Vaasa, Finland, 65130
  • France
      • Antony Cedex, France, 92166
      • Bordeaux, France, 33000
      • Brest Cedex, France, 29609
      • Caen Cedex, France, 14033
      • Dijon, France, 21033
      • Le Chesnay, France, 78150
      • Limoges, France, 87042
      • NIMES cedex 9, France, 30029
      • Nantes, France, 44035
      • PARIS cedex 14, France, 75674
      • Paris, France, 75018
      • Paris, France, 75475
      • Paris, France, 75012
      • Paris, France, 75634
      • Saint Priest En Jarez, France, 42270
      • Strasbourg, France, 67091
  • Germany
      • Berlin, Germany, 12200
      • Hamburg, Germany, 22417
    • Baden-Württemberg
      • Freiburg, Baden-Württemberg, Germany, 79106
      • Mannheim, Baden-Württemberg, Germany, 68167
    • Bayern
      • München, Bayern, Germany, 81675
      • Regensburg, Bayern, Germany, 93053
      • Würzburg, Bayern, Germany, 97080
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
    • Nordrhein-Westfalen
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
      • Meerbusch, Nordrhein-Westfalen, Germany, 40670
      • Wuppertal, Nordrhein-Westfalen, Germany, 42283
    • Sachsen
      • Dresden, Sachsen, Germany, 01307
      • Dresden, Sachsen, Germany, 01129
      • Markkleeberg, Sachsen, Germany, 04416
      • Wermsdorf, Sachsen, Germany, 04779
    • Sachsen-Anhalt
      • Halle, Sachsen-Anhalt, Germany, 06120
    • Thüringen
      • Altenburg, Thüringen, Germany, 04600
  • Greece
      • Athens, Greece, 11521
      • Athens, Greece, 11528
      • Ioannina, Greece, 45500
      • Larissa, Greece, 41100
      • Thessaloniki, Greece, 546 36
  • Hungary
      • Budapest, Hungary, 1083
      • Budapest, Hungary, 1134
      • Budapest, Hungary, 1204
      • Debrecen, Hungary, 4012
      • Eger, Hungary, 3300
      • Gyor, Hungary, 9002
      • Kistarcsa, Hungary, 2143
      • Miskolc, Hungary, 35-26
      • Nagykanizsa, Hungary, 8800
      • Nyiregyhaza, Hungary, H-4400
      • Sopron, Hungary, 9400
      • Szeged, Hungary, 6720
      • Zalaegerszeg, Hungary, 8900
  • Ireland
      • Dublin, Ireland, DUBLIN 7
      • Galway, Ireland
  • Israel
      • Ashkelon, Israel, 7827804
      • Beer Sheva, Israel, 8410101
      • Haifa, Israel, 3339419
      • Haifa, Israel, 3436212
      • Jerusalem, Israel
      • Petah Tikva, Israel, 4941492
      • Ramat Gan, Israel, 5262000
      • Tel Aviv, Israel, 6423906
  • Italy
    • Abruzzo
      • L'Aquila, Abruzzo, Italy, 67100
    • Calabria
      • Vibo Valentia, Calabria, Italy, 89900
    • Emilia-Romagna
      • Parma, Emilia-Romagna, Italy, 43126
    • Friuli-Venezia Giulia
      • Trieste, Friuli-Venezia Giulia, Italy, 34100
    • Lazio
      • Roma, Lazio, Italy, 00168
      • Roma, Lazio, Italy, 00133
      • Roma, Lazio, Italy, 00152
      • Roma, Lazio, Italy, 00161
    • Lombardia
      • Milano, Lombardia, Italy, 20132
      • Milano, Lombardia, Italy, 20122
      • Milano, Lombardia, Italy, 20162
      • Pavia, Lombardia, Italy, 27100
    • Marche
      • Ancona, Marche, Italy, 60126
    • Molise
      • Isernia, Molise, Italy, 86077
    • Sardegna
      • Cagliari, Sardegna, Italy, 09134
    • Umbria
      • Perugia, Umbria, Italy, 06156
      • Perugia, Umbria, Italy, 06012
      • Perugia, Umbria, Italy, 06024
    • Veneto
      • Verona, Veneto, Italy, 37126
      • Verona, Veneto, Italy, 37024
  • Japan
      • Fukuoka, Japan, 810-8563
      • Fukuoka, Japan, 811-0213
      • Fukuoka, Japan, 810-0001
      • Hiroshima, Japan, 730-8518
      • Kakogawa, Japan, 675-0122
      • Kochi, Japan, 780-8522
      • Kyoto, Japan, 602-8026
      • Kyoto, Japan, 600-8558
      • Kyoto, Japan, 601-1495
      • Niigata, Japan, 950-1197
      • Okayama, Japan, 700-8557
    • Aichi
      • Nagoya, Aichi, Japan, 454-8502
      • Nagoya, Aichi, Japan, 457-8511
      • Nagoya, Aichi, Japan, 460-0001
      • Okazaki, Aichi, Japan, 444-8553
      • Seto, Aichi, Japan, 489-8642
      • Toyota, Aichi, Japan, 471-8513
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan, 802-8555
      • Kitakyushu, Fukuoka, Japan, 805-0050
    • Fukushima
      • Koriyama, Fukushima, Japan, 963-8052
    • Hiroshima
      • Fukuyama, Hiroshima, Japan, 720-0825
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8530
      • Hakodate, Hokkaido, Japan, 041-0802
      • Kushiro, Hokkaido, Japan, 085-0061
    • Hyogo
      • Kobe, Hyogo, Japan, 652-0803
      • Kobe, Hyogo, Japan, 650-0047
      • Kobe, Hyogo, Japan, 654-0048
      • Nishinomiya, Hyogo, Japan, 663-8211
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1193
      • Kawasaki, Kanagawa, Japan, 216-8511
    • Miyagi
      • Sendai, Miyagi, Japan, 982-8523
    • Nagasaki
      • Sasebo, Nagasaki, Japan, 857-0134
    • Nara
      • Tenri, Nara, Japan, 632-8552
    • Okayama
      • Kurashiki, Okayama, Japan, 710-8602
    • Osaka
      • Matsubara, Osaka, Japan, 580-0032
      • Sakai, Osaka, Japan, 590-0064
      • Suita, Osaka, Japan, 565-8565
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
      • Hachioji, Tokyo, Japan, 192-0032
      • Kodaira, Tokyo, Japan, 187-8510
      • Musashino, Tokyo, Japan, 180-8610
      • Shinjuku-ku, Tokyo, Japan, 162-8666
      • Sumida-ku, Tokyo, Japan, 130-8575
  • Korea, Republic of
      • Busan, Korea, Republic of, 49201
      • Daegu, Korea, Republic of, 41931
      • Daegu, Korea, Republic of, 42415
      • Incheon, Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
      • Seoul, Korea, Republic of, 120-752
      • Seoul, Korea, Republic of, 05505
      • Seoul, Korea, Republic of, 06351
      • Seoul, Korea, Republic of, 130-872
      • Seoul,, Korea, Republic of, 139-872
    • Gwangju Gwang''yeogsi
      • Donggu,, Gwangju Gwang''yeogsi, Korea, Republic of, 61469
    • Gyeonggido
      • Anyang-si, Gyeonggido, Korea, Republic of, 431-070
      • Goyang, Gyeonggido, Korea, Republic of, 411-706
      • Seongnam-si, Gyeonggido, Korea, Republic of, 463-707
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 152-703
  • Mexico
      • Aguascalientes, Mexico, 20127
      • México D.F., Mexico
    • Distrito Federal
      • Delegación Gustavo A. Madero, Distrito Federal, Mexico, 07760
      • México, D.F., Distrito Federal, Mexico, 14080
    • Michoacán
      • Morelia, Michoacán, Mexico, 58000
    • México
      • México D.F., México, Mexico, 06720
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64460
    • Yucatán
      • Merida, Yucatán, Mexico, 97070
  • Poland
      • Bialystok, Poland, 15-276
      • Chelm, Poland, 22-100
      • Gdansk, Poland, 80-803
      • Gdansk, Poland, 80-952
      • Katowice, Poland, 40-635
      • Konskie, Poland, 26-200
      • Lodz, Poland, 90-153
      • Lodz, Poland, 90-549
      • Olsztyn, Poland, 10-561
      • Sandomierz, Poland
      • Siedlce, Poland, 08-110
      • Skarzysko-Kamienna, Poland, 26-110
      • Warszawa, Poland, 00-146
      • Warszawa, Poland, 02957
      • Warszawa, Poland, 03-242
  • Portugal
      • Almada, Portugal, 2801-951
      • Amadora, Portugal, 2720-276
      • Coimbra, Portugal, 3030-075
      • Lisboa, Portugal, 1198
      • Porto, Portugal, 4200-319
      • Porto, Portugal, 4099-001
      • Vila Franca de Xira, Portugal, P 2600-178
    • Porto
      • Vilanova De Gaia, Porto, Portugal, 4434-502
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454021
      • Ekaterinburg, Russian Federation, 620017
      • Kaluga, Russian Federation, 248010
      • Kazan, Russian Federation, 420012
      • Krasnoyarsk, Russian Federation, 660022
      • Moscow, Russian Federation, 119049
      • Moscow, Russian Federation, 117997
      • Nizhny Novgorod, Russian Federation, 603005
      • St. Petersburg, Russian Federation, 194354
      • St. Petersburg, Russian Federation, 196247
      • St. Petersburg, Russian Federation, 190068
      • St. Petersburg, Russian Federation, 191186
      • Tomsk, Russian Federation, 634063
      • Ulyanovsk, Russian Federation, 432063
      • Volgograd, Russian Federation, 400131
      • Yaroslavl, Russian Federation, 150000
      • Yekaterinburg, Russian Federation, 620102
  • South Africa
      • Durban, South Africa, 4100
    • Western Cape
      • Cape Town, Western Cape, South Africa, 7531
      • Somerset West, Western Cape, South Africa, 7130
  • Spain
      • A Coruña, Spain, 15006
      • Badajoz, Spain, 06080
      • Barcelona, Spain, 08036
      • Barcelona, Spain, 08003
      • Barcelona, Spain, 08035
      • Barcelona, Spain, 08041
      • Bilbao, Spain, 48013
      • Cáceres, Spain, 10003
      • Girona, Spain, 17007
      • Granada, Spain, 18014
      • León, Spain, 24008
      • Lleida, Spain, 25198
      • Madrid, Spain, 28006
      • Madrid, Spain, 28046
      • Madrid, Spain, 28007
      • Sevilla, Spain, 41013
      • Sevilla, Spain, 41009
      • Valencia, Spain, 46026
      • Valladolid, Spain, 47011
      • Zaragoza, Spain, 50009
    • A Coruña
      • Santiago de Compostela, A Coruña, Spain, 15706
    • Barcelona
      • Badalona, Barcelona, Spain, 08916
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Sant Joan Despi, Barcelona, Spain, 08970
    • Castellón
      • Castellón de la Plana, Castellón, Spain, 12004
    • Murcia
      • El Palmar (Murcia), Murcia, Spain, 30120
  • Sweden
      • Goteborg, Sweden, 413 45
      • Hässleholm, Sweden, 281 25
      • Lund, Sweden, 221 85
      • Malmö, Sweden, 205 02
      • Umeå, Sweden, 901 85
  • Switzerland
      • Baden, Switzerland, 5404
      • Bern, Switzerland, 3010
      • Fribourg, Switzerland, 1700
      • Genève, Switzerland, 1205
      • Zürich, Switzerland, 8032
    • Aargau
      • Aarau, Aargau, Switzerland, 5001
    • Basel-Stadt
      • Basel, Basel-Stadt, Switzerland, 4056
    • Ticino
      • Lugano, Ticino, Switzerland, 6900
  • Turkey
      • Ankara, Turkey, 06500
      • Ankara, Turkey, 6100
      • Antakya, Turkey, 31000
      • Istanbul, Turkey
      • Istanbul, Turkey, 34098
      • Kahramanmaras, Turkey, 46000
      • Konya, Turkey, 42080
      • Konya, Turkey, 42075
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZN
      • Durham, United Kingdom, DH1 5TW
      • Edinburgh, United Kingdom, EH16 4SA
      • London, United Kingdom, WC1N 3BG
      • London, United Kingdom, N18 1QX
      • London, United Kingdom, SE5 8AF
      • London, United Kingdom, W6 8RP
      • Luton, United Kingdom, LU4 0DZ
      • Norwich, United Kingdom, NR4 7UY
    • Buckinghamshire
      • High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
      • Milton Keynes, Buckinghamshire, United Kingdom, MK6 5LD
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    • Devon
      • Exeter, Devon, United Kingdom, EX2 5DW
    • Essex
      • Colchester, Essex, United Kingdom, CO4 5JR
      • Westcliff-on-Sea, Essex, United Kingdom, SS0 0RY
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
    • Hertfordshire
      • Watford, Hertfordshire, United Kingdom, WD1 8HB
    • Kent
      • Ashford, Kent, United Kingdom, TN24 0LZ
      • Margate, Kent, United Kingdom, CT9 4AN
    • Leicestershire
      • Leicester, Leicestershire, United Kingdom, LE2 7LX
    • Lincolnshire
      • Boston, Lincolnshire, United Kingdom, PE21 9QS
    • London
      • Harrow, London, United Kingdom, HA1 3UJ
    • Norfolk
      • Great Yarmouth, Norfolk, United Kingdom, NR31 6LA
    • Somerset
      • Taunton, Somerset, United Kingdom, TA1 5DA
      • Yeovil, Somerset, United Kingdom, BA21 4AT
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
    • Staffordshire
      • Stoke-On-Trent, Staffordshire, United Kingdom, ST4 6QG
    • Stratchclyde
      • Glasgow, Stratchclyde, United Kingdom, G51 4TF
    • Tyne And Wear
      • Gateshead, Tyne And Wear, United Kingdom, NE9 6SX
      • Sunderland, Tyne And Wear, United Kingdom, SR4 7TP
    • West Midlands
      • Wolverhampton, West Midlands, United Kingdom, WV10 0QP
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS1 3EX
    • Wiltshire
      • Salisbury, Wiltshire, United Kingdom, SP2 8BJ
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85724
    • California
      • Long Beach, California, United States, 90806
      • Stanford, California, United States, 94305-5119
      • Torrance, California, United States, 90502
    • Connecticut
      • New Haven, Connecticut, United States, 06520-8064
    • Florida
      • Gainesville, Florida, United States, 32611
    • Illinois
      • Joliet, Illinois, United States, 60435
    • Iowa
      • Iowa City, Iowa, United States, 52242-1089
    • Kentucky
      • Lexington, Kentucky, United States, 40536
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
    • Maryland
      • Baltimore, Maryland, United States, 21210
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
      • Boston, Massachusetts, United States, 02118
      • Worcester, Massachusetts, United States, 01655
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-0330
      • Mount Clemens, Michigan, United States, 48043
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
    • New York
      • Buffalo, New York, United States, 14203
      • New York, New York, United States, 10016-4576
    • Ohio
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44195
      • Cleveland, Ohio, United States, 44106-2602
    • Oregon
      • Portland, Oregon, United States, 97225
      • Portland, Oregon, United States, 97239-3011
    • Pennsylvania
      • Erie, Pennsylvania, United States, 16550
      • Philadelphia, Pennsylvania, United States, 19104
      • Pittsburgh, Pennsylvania, United States, 15212
    • South Carolina
      • Charleston, South Carolina, United States, 29425
      • Columbia, South Carolina, United States, 29203-8004
    • Tennessee
      • Nashville, Tennessee, United States, 37232-5400
    • Texas
      • Austin, Texas, United States, 78701
      • Dallas, Texas, United States, 75390
      • El Paso, Texas, United States, 79905-2709
      • Houston, Texas, United States, 77030
      • San Antonio, Texas, United States, 78229
      • Temple, Texas, United States, 76504
    • Utah
      • Salt Lake City, Utah, United States, 84312
    • Washington
      • Seattle, Washington, United States, 98102

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Recent ESUS (between 7 days and 6 months), defined as:
  • 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:

  • Severely disabling stroke (modified Rankin score ≥4)
  • Indication for chronic anticoagulation or antiplatelet therapy
  • Estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m^2

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rivaroxaban
Rivaroxaban 15 mg orally once daily
Drug: Rivaroxaban (Xarelto, BAY59-7939)
15 mg, once daily, orally, tablet
Other: Rivaroxaban-Placebo
Matching placebo, once daily, orally, tablet
Active Comparator: Aspirin
Aspirin 100 mg orally once daily
Drug: Acetylsalicylic acid (Aspirin, BAY1019036)
100 mg, once daily, orally, tablet
Other: Aspirin-Placebo
Matching placebo, once daily, orally, tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of the Composite Efficacy Outcome (Adjudicated)
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Components of composite efficacy outcome (adjudicated) includes stroke (ischemic, hemorrhagic, and undefined stroke, TIA with positive neuroimaging) and systemic embolism. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Major bleeding event (as per ISTH), defined as bleeding event that met at least one of following: fatal bleeding; symptomatic bleeding in a critical area or organ (intraarticular, intramuscular with compartment syndrome, intraocular, intraspinal, pericardial, or retroperitoneal); symptomatic intracranial haemorrhage; clinically overt bleeding associated with a recent decrease in the hemoglobin level of greater than or equal to (>=) 2 grams per decilitre (g/dL) (20 grams per liter [g/L]; 1.24 millimoles per liter [mmol/L]) compared to the most recent hemoglobin value available before the event; clinically overt bleeding leading to transfusion of 2 or more units of packed red blood cells or whole blood. The results were based on classification of events that have been positively adjudicated as major bleeding events. Incidence rate estimated as number of subjects with incident events divided by cumulative at-risk time, where subject is no longer at risk once an incident event occurred.
From randomization until the efficacy cut-off date (median 326 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred. Cardiovascular death includes death due to hemorrhage and death with undetermined/unknown cause. Systemic embolism is defined as abrupt vascular insufficiency associated with clinical or radiological evidence of arterial occlusion in the absence of other likely mechanisms. The diagnosis of myocardial infarction requires the combination of: 1)evidence of myocardial necrosis (either changes in cardiac biomarkers or post-mortem pathological findings); and 2)supporting information derived from the clinical presentation, electrocardiographic changes, or the results of myocardial or coronary artery imaging.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of All-Cause Mortality
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
All-cause mortality includes all deaths of participants due to any cause.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Disabling stroke is defined as stroke with modified Rankin score (mRS) greater than or equal to (>=) 4 as assessed by investigator. mRS spans 0-6, running from perfect health to death. A score of 0-3 indicates functional status ranging from no symptoms to "moderate disability" (defined in the mRS as requiring some help, but able to walk without assistance); mRS 4-6 indicates functional status ranging from "moderately severe disability" (unable to walk or to attend to own bodily needs without assistance)through to death. CV death includes death due to hemorrhage and death with undetermined/unknown cause. Diagnosis of myocardial infarction requires combination of: 1) evidence of myocardial necrosis either changes in cardiac biomarkers or post-mortem pathological findings); 2) supporting information derived from clinical presentation, electrocardiographic changes, or results of myocardial or coronary artery imaging.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of Life-Threatening Bleeding Events
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Life-threatening bleeding was defined as a subset of major bleeding that met at least one of the following criteria: 1) fatal bleeding; 2) symptomatic intracranial haemorrhage; 3) reduction in hemoglobin of at least 5 g/dl (50 g/l; 3.10 mmol/L); 4) transfusion of at least 4 units of packed red cells or whole blood; 5) associated with hypotension requiring the use of intravenous inotropic agents; 6) necessitated surgical intervention. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of Clinically Relevant Non-Major Bleeding Events
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Non-major clinically relevant bleeding was defined as non-major overt bleeding but required medical attention (example: hospitalization, medical treatment for bleeding), and/or was associated with the study drug interruption of more than 14 days. The results were based on the outcome events at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
From randomization until the efficacy cut-off date (median 326 days)
Incidence Rate of Intracranial Hemorrhage
Time Frame: From randomization until the efficacy cut-off date (median 326 days)
Intracranial hemorrhage included all bleeding events that occurred in intracerebral, sub arachnoidal as well as subdural or epidural sites. The below table displays results for all randomized participants and the outcomes at or after randomization until the efficacy cut-off date. Incidence rate estimated as number of participants with incident events divided by cumulative at-risk time, where participant is no longer at risk once an incident event occurred.
From randomization until the efficacy cut-off date (median 326 days)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Collaborators

Janssen Research & Development, LLC
Population Health Research Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 23, 2014

Primary Completion (Actual)

February 15, 2018

Study Completion (Actual)

February 15, 2018

Study Registration Dates

First Submitted

December 8, 2014

First Submitted That Met QC Criteria

December 9, 2014

First Posted (Estimate)

December 10, 2014

Study Record Updates

Last Update Posted (Actual)

January 9, 2019

Last Update Submitted That Met QC Criteria

December 20, 2018

Last Verified

December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16573
  • 2013-000768-27 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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