stop_circleTerminated/Withdrawn
Stroke
Bayer Identifier:
16573
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Rivaroxaban versus Aspirin in secondary prevention of stroke and prevention of systemic embolism in patients with recent embolic stroke of undetermined source (ESUS)
Trial purpose
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.
Key Participants Requirements
Sex
AllAge
50 - N/ATrial summary
Enrollment Goal
7213Trial Dates
December 2014 - February 2018Phase
Phase 3Could I Receive a placebo
YesProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Roma, 00161, Italy | |
Completed | São Paulo, 01228-000, Brazil | |
Completed | Basel, 4056, Switzerland | |
Completed | Hamilton, L8L 2X2, Canada | |
Completed | Brussel, 1090, Belgium | |
Completed | Lund, 221 85, Sweden | |
Completed | Buenos Aires, 1428, Argentina | |
Completed | Moscow, 117997, Russia | |
Completed | Helsinki, 00029, Finland | |
Completed | México D.F., Mexico | |
Completed | Santiago, 7650567, Chile | |
Completed | Seoul, 110-744, Korea, Republic Of | |
Completed | Philadelphia, 19104, United States | |
Completed | San Antonio, 78229, United States | |
Completed | Tucson, 85724, United States | |
Completed | Glasgow, G51 4TF, United Kingdom | |
Completed | London, W6 8RP, United Kingdom | |
Completed | Badalona, 08916, Spain | |
Completed | Nedlands, 6009, Australia | |
Completed | Berlin, 12200, Germany | |
Completed | Milano, 20132, Italy | |
Completed | Perugia, 06012, Italy | |
Completed | Perugia, 06156, Italy | |
Completed | Mar del Plata, B7602CBM, Argentina | |
Completed | Buenos Aires, C1437JCP, Argentina | |
Completed | Wermsdorf, 04779, Germany | |
Withdrawn | Tübingen, 72076, Germany | |
Completed | Regensburg, 93053, Germany | |
Completed | Hamburg, 22417, Germany | |
Completed | Hannover, 30625, Germany | |
Completed | Warszawa, 02957, Poland | |
Completed | Skarzysko-Kamienna, 26-110, Poland | |
Completed | ANTWERPEN, 2020, Belgium | |
Completed | BRUXELLES - BRUSSEL, 1070, Belgium | |
Completed | Coimbra, 3030-075, Portugal | |
Completed | Altenburg, 04600, Germany | |
Completed | Exeter, EX2 5DW, United Kingdom | |
Withdrawn | Worcester, WR5 1DD, United Kingdom | |
Completed | London, WC1N 3BG, United Kingdom | |
Completed | Harrow, HA1 3UJ, United Kingdom | |
Completed | Edinburgh, EH16 4SA, United Kingdom | |
Completed | Boston, 02118, United States | |
Completed | Portland, 97239-3011, United States | |
Completed | Brno, 656 91, Czech Republic | |
Completed | Ostrava-Poruba, 708 52, Czech Republic | |
Completed | Jihlava, 58633, Czech Republic | |
Completed | Vilanova de Gaia, 4434-502, Portugal | |
Completed | Würzburg, 97080, Germany | |
Completed | Freiburg, 79106, Germany | |
Completed | Düsseldorf, 40225, Germany | |
Withdrawn | München, 81545, Germany | |
Completed | Dresden, 01307, Germany | |
Completed | München, 81675, Germany | |
Completed | Gloucester, GL1 3NN, United Kingdom | |
Completed | Gateshead, NE9 6SX, United Kingdom | |
Completed | Watford, WD1 8HB, United Kingdom | |
Completed | High Wycombe, HP11 2TT, United Kingdom | |
Completed | Stoke-On-Trent, ST4 6QG, United Kingdom | |
Completed | Westcliff-on-Sea, SS0 0RY, United Kingdom | |
Completed | Baltimore, 21210, United States | |
Completed | Columbia, 29203-8004, United States | |
Completed | Boston, 02111, United States | |
Completed | PARIS, 75018, France | |
Completed | PARIS, 75634, France | |
Completed | Konskie, 26-200, Poland | |
Completed | Bialystok, 15-276, Poland | |
Completed | Siedlce, 08-110, Poland | |
Completed | Warszawa, 00-146, Poland | |
Completed | Milano, 20122, Italy | |
Completed | Verona, 37126, Italy | |
Completed | Vibo Valentia, 89900, Italy | |
Completed | Ancona, 60126, Italy | |
Completed | Pavia, 27100, Italy | |
Withdrawn | Modena, 41100, Italy | |
Completed | Madrid, 28046, Spain | |
Completed | Madrid, 28006, Spain | |
Completed | Valencia, 46026, Spain | |
Completed | Barcelona, 08041, Spain | |
Withdrawn | Albacete, 02006, Spain | |
Completed | Santiago de Compostela, 15706, Spain | |
Completed | Barcelona, 08036, Spain | |
Completed | HASSELT, 3500, Belgium | |
Completed | EDEGEM, 2650, Belgium | |
Completed | México, D.F., 14080, Mexico | |
Withdrawn | Villahermosa, 86126, Mexico | |
Completed | México D.F., 06720, Mexico | |
Completed | Malmö, 205 02, Sweden | |
Completed | Glostrup, 2600, Denmark | |
Completed | Aarhus C, 8000, Denmark | |
Withdrawn | Cape Town, 7935, South Africa | |
Completed | Cape Town, 7531, South Africa | |
Completed | Durban, 4100, South Africa | |
Completed | Somerset West, 7130, South Africa | |
Completed | Somerset West, 7130, South Africa | |
Completed | Olomouc, 775 20, Czech Republic | |
Completed | Praha 3, 10034, Czech Republic | |
Completed | Ostrava Vitkovice, Czech Republic | |
Completed | Porto, 4200-319, Portugal | |
Completed | Porto, 4099-001, Portugal | |
Completed | Buenos Aires, C1039AAO, Argentina | |
Completed | Rosario, S2000DSV, Argentina | |
Completed | Banfield, 1828, Argentina | |
Terminated (Halted Prematurely) | Ciudad Auton. de Buenos Aires, C1405CNF, Argentina | |
Withdrawn | Salta, A4402AYT, Argentina | |
Completed | Buenos Aires, 1078, Argentina | |
Completed | Viña del Mar, Chile | |
Completed | Porto Alegre, 90110-270, Brazil | |
Completed | Matão, 15990-060, Brazil | |
Completed | Joinville, 89202-165, Brazil | |
Completed | Seoul, 120-752, Korea, Republic Of | |
Completed | Incheon, Korea, Republic Of | |
Completed | SEOUL,, 139-872, Korea, Republic Of | |
Completed | Donggu,, 61469, Korea, Republic Of | |
Withdrawn | Jung-gu Daejeon, 301-721, Korea, Republic Of | |
Completed | Goyang, 411-706, Korea, Republic Of | |
Completed | Seoul, 152-703, Korea, Republic Of | |
Completed | Anyang-si, 431-070, Korea, Republic Of | |
Completed | Seongnam-si, 463-707, Korea, Republic Of | |
Completed | Galway, Ireland | |
Completed | Dublin, DUBLIN 7, Ireland | |
Completed | Edmonton, T6G 2B7, Canada | |
Completed | NANTES, 44035, France | |
Completed | PARIS, 75475, France | |
Completed | Cagliari, 09134, Italy | |
Completed | Busan, 49201, Korea, Republic Of | |
Completed | Kitakyushu, 805-0050, Japan | |
Terminated | Asahikawa, 070-8530, Japan | |
Completed | Fukuoka, 810-8563, Japan | |
Completed | Nagoya, 454-8502, Japan | |
Completed | Fukuyama, 720-0825, Japan | |
Completed | Kobe, 650-0047, Japan | |
Completed | Hidaka, 350-1298, Japan | |
Completed | Sumida-ku, 130-8575, Japan | |
Completed | Almada, 2801-951, Portugal | |
Withdrawn | Aomori, 030-8553, Japan | |
Completed | Koriyama, 963-8052, Japan | |
Withdrawn | Zürich, 8091, Switzerland | |
Completed | Aarau, 5001, Switzerland | |
Completed | Lugano, 6900, Switzerland | |
Completed | BORDEAUX, 33000, France | |
Completed | Buenos Aires, C1431FWO, Argentina | |
Completed | San Martín, 1650, Argentina | |
Completed | Córdoba, X5000JHQ, Argentina | |
Completed | Parma, 43126, Italy | |
Completed | Perugia, 06024, Italy | |
Completed | Aalborg, 9100, Denmark | |
Completed | Budapest, 1083, Hungary | |
Completed | Nyiregyhaza, H-4400, Hungary | |
Withdrawn | Szekszard, 7100, Hungary | |
Completed | Eger, 3300, Hungary | |
Completed | Miskolc, 35-26, Hungary | |
Completed | Szeged, 6720, Hungary | |
Completed | Budapest, 1134, Hungary | |
Completed | Debrecen, 4012, Hungary | |
Completed | Sopron, 9400, Hungary | |
Withdrawn | Morelia, 58070, Mexico | |
Completed | Turku, 20520, Finland | |
Withdrawn | Katowice, 40-752, Poland | |
Completed | Gdansk, 80-803, Poland | |
Completed | Buenos Aires, C1221 ADC, Argentina | |
Completed | Seoul, 05505, Korea, Republic Of | |
Completed | Amadora, 2720-276, Portugal | |
Completed | St. Petersburg, 196247, Russia | |
Completed | St. Petersburg, 190068, Russia | |
Completed | Moscow, 117997, Russia | |
Completed | Kakogawa, 675-0122, Japan | |
Completed | Sendai, 982-8523, Japan | |
Completed | Okazaki, 444-8553, Japan | |
Completed | Kyoto, 602-8026, Japan | |
Completed | Kurashiki, 710-8602, Japan | |
Completed | Quebec, G1J 1Z4, Canada | |
Completed | Halifax, B3H 2Y5, Canada | |
Completed | Ribeirão Preto, 14015-130, Brazil | |
Completed | São Paulo, 08270-070, Brazil | |
Completed | OYS, 90029, Finland | |
Completed | Granada, 18014, Spain | |
Completed | Girona, 17007, Spain | |
Completed | Barcelona, 08003, Spain | |
Completed | Madrid, 28007, Spain | |
Completed | Shinjuku-ku, 162-8666, Japan | |
Completed | Copenhagen, 2400, Denmark | |
Withdrawn | Temuco, 4781151, Chile | |
Withdrawn | Dublin, 9, Ireland | |
Completed | Roma, 00168, Italy | |
Completed | Isernia, 86077, Italy | |
Completed | L'Aquila, 67100, Italy | |
Completed | Gyor, 9002, Hungary | |
Completed | Salt Lake City, 84312, United States | |
Withdrawn | New York, 10065, United States | |
Completed | Pittsburgh, 15212, United States | |
Completed | Seattle, 98102, United States | |
Withdrawn | St. Louis, 63110, United States | |
Completed | Gainesville, 32611, United States | |
Completed | New Orleans, 70121, United States | |
Completed | London, SE5 8AF, United Kingdom | |
Completed | Norwich, NR4 7UY, United Kingdom | |
Completed | Barcelona, 08035, Spain | |
Completed | Kazan, 420012, Russia | |
Withdrawn | Kazan, 420101, Russia | |
Completed | Montreal, H3G 1A4, Canada | |
Withdrawn | Adelaide, 5042, Australia | |
Terminated | Lisboa, 1198, Portugal | |
Withdrawn | Punta Arenas, 6210005, Chile | |
Completed | Zalaegerszeg, 8900, Hungary | |
Completed | Seoul, 06351, Korea, Republic Of | |
Completed | Salvador, 41253-190, Brazil | |
Completed | Rio de Janeiro, 22281-100, Brazil | |
Withdrawn | Salvador, 40296-710, Brazil | |
Completed | Campinas, 13081-000, Brazil | |
Completed | Sandomierz, Poland | |
Completed | Cáceres, 10003, Spain | |
Completed | Aguascalientes, 20127, Mexico | |
Completed | Kawasaki, 216-8511, Japan | |
Completed | Kochi, 780-8522, Japan | |
Completed | Bunkyo-ku, 113-8603, Japan | |
Completed | Beijing, 100050, China | |
Completed | Okayama, 700-8557, Japan | |
Completed | Suita, 565-8565, Japan | |
Completed | Kitakyushu, 802-8555, Japan | |
Withdrawn | Kumamoto, 861-8520, Japan | |
Completed | Calgary, T2N 2T9, Canada | |
Completed | Toronto, M4N 3M5, Canada | |
Completed | Ottawa, K1Y 4E9, Canada | |
Completed | Osorno, Chile | |
Completed | Edmonton, T6L 5X8, Canada | |
Withdrawn | Toronto, M5B 1W8, Canada | |
Completed | Brugge, 8310, Belgium | |
Completed | Footscray, 3011, Australia | |
Completed | Elizabeth Vale, 5112, Australia | |
Completed | Clayton, 3168, Australia | |
Completed | Camperdown, 2050, Australia | |
Withdrawn | Chihuahua, 31238, Mexico | |
Completed | Praha 2, 128 21, Czech Republic | |
Completed | Valladolid, 47011, Spain | |
Withdrawn | Sydney, 2010, Australia | |
Completed | Budapest, 1204, Hungary | |
Completed | Luton, LU4 0DZ, United Kingdom | |
Terminated | Salisbury, SP2 8BJ, United Kingdom | |
Completed | Aberdeen, AB25 2ZN, United Kingdom | |
Completed | Cambridge, CB2 0QQ, United Kingdom | |
Withdrawn | Poole, BH15 2JB, United Kingdom | |
Completed | Monterrey, 64460, Mexico | |
Completed | Lodz, 90-549, Poland | |
Withdrawn | Pila, 64- 920, Poland | |
Completed | Niigata, 950-1197, Japan | |
Completed | Tenri, 632-8552, Japan | |
Completed | Isehara, 259-1193, Japan | |
Withdrawn | Matsudo, 270-2251, Japan | |
Completed | Matsubara, 580-0032, Japan | |
Completed | Kobe, 654-0048, Japan | |
Completed | Seto, 489-8642, Japan | |
Completed | Kobe, 652-0803, Japan | |
Completed | Nagoya, 457-8511, Japan | |
Completed | Kyoto, 600-8558, Japan | |
Completed | Musashino, 180-8610, Japan | |
Completed | Kodaira, 187-8510, Japan | |
Completed | Chicoutimi, G7H 5H6, Canada | |
Withdrawn | Montreal, H3T 1E2, Canada | |
Completed | London, N6A 5A5, Canada | |
Withdrawn | Toronto, M5T 2S8, Canada | |
Completed | Saint John, E2L 4L2, Canada | |
Completed | St. Jerome, J7Z 5T3, Canada | |
Completed | Vancouver, V5Z 1M9, Canada | |
Completed | Victoria, V8R 1J8, Canada | |
Completed | Kistarcsa, 2143, Hungary | |
Completed | Ekaterinburg, 620017, Russia | |
Completed | Chelyabinsk, 454021, Russia | |
Completed | Moscow, 117997, Russia | |
Completed | LE CHESNAY, 78150, France | |
Completed | Rosario, Argentina | |
Completed | Valdivia, Chile | |
Withdrawn | Buenos Aires, C1209AAB, Argentina | |
Completed | Ann Arbor, 48109-0330, United States | |
Withdrawn | Minneapolis, 55455, United States | |
Completed | New Brunswick, 08901, United States | |
Withdrawn | Birmingham, B15 2GW, United Kingdom | |
Completed | Wolverhampton, WV10 0QP, United Kingdom | |
Completed | Great Yarmouth, NR31 6LA, United Kingdom | |
Withdrawn | Decatur, 30033, United States | |
Completed | Milano, 20162, Italy | |
Withdrawn | Buenos Aires, C1115AAB, Argentina | |
Completed | Badajoz, 06080, Spain | |
Completed | Sairaalamäki, 45750, Finland | |
Completed | Tampere, FIN-33520, Finland | |
Completed | Yekaterinburg, 620102, Russia | |
Withdrawn | Campinas, 13060-646, Brazil | |
Completed | Porto Alegre, Brazil | |
Completed | Ribeirão Preto, 14048-900, Brazil | |
Completed | Nagoya, 460-0001, Japan | |
Withdrawn | Kuki, 349-1105, Japan | |
Completed | New Haven, 06520-8064, United States | |
Completed | New York, 10016-4576, United States | |
Completed | Iowa City, 52242-1089, United States | |
Withdrawn | Erlangen, 91054, Germany | |
Withdrawn | Aachen, 52074, Germany | |
Completed | Sasebo, 857-0134, Japan | |
Withdrawn | Ciudad de México, 06729, Mexico | |
Completed | DENDERMONDE, 9200, Belgium | |
Completed | Umeå, 901 85, Sweden | |
Completed | L'Hospitalet de Llobregat, 08907, Spain | |
Completed | Castellón de la Plana, 12004, Spain | |
Completed | Kaluga, 248010, Russia | |
Completed | Brno, 625 00, Czech Republic | |
Withdrawn | CLERMONT FERRAND, 63000, France | |
Completed | DIJON, 21033, France | |
Completed | PARIS, 75012, France | |
Withdrawn | ANNECY, 74000, France | |
Completed | Wuppertal, 42283, Germany | |
Completed | Murdoch, 6150, Australia | |
Completed | Viña del Mar, Chile | |
Completed | Los Angeles, Chile | |
Completed | Brisbane, 4029, Australia | |
Completed | Lethbridge, T1K 0C9, Canada | |
Completed | Nagykanizsa, 8800, Hungary | |
Completed | Yaroslavl, 150000, Russia | |
Completed | Ashford, TN24 0LZ, United Kingdom | |
Completed | León, 24008, Spain | |
Completed | Mississauga, L5B 2V2, Canada | |
Completed | Goteborg, 413 45, Sweden | |
Completed | Hässleholm, 281 25, Sweden | |
Completed | SAINT PRIEST EN JAREZ, 42270, France | |
Withdrawn | Córdoba, X5004BAL, Argentina | |
Completed | Santa Fe, 3000, Argentina | |
Completed | Worcester, 01655, United States | |
Completed | STRASBOURG, 67091, France | |
Completed | Charleston, 29425, United States | |
Completed | Joliet, 60435, United States | |
Completed | Cleveland, 44106-2602, United States | |
Completed | Blansko, 67801, Czech Republic | |
Withdrawn | Pamplona, 31008, Spain | |
Completed | Kushiro, 085-0061, Japan | |
Terminated (Halted Prematurely) | Southport, 4215, Australia | |
Completed | Halle, 06120, Germany | |
Completed | Porto Alegre, 90035-001, Brazil | |
Completed | Botucatu, 18618 970, Brazil | |
Withdrawn | Sao Paulo, 05403-900, Brazil | |
Completed | Sevilla, 41009, Spain | |
Completed | Waratah, 2298, Australia | |
Completed | Daegu, 41931, Korea, Republic Of | |
Completed | Zürich, 8032, Switzerland | |
Completed | Olsztyn, 10-561, Poland | |
Completed | Chelm, 22-100, Poland | |
Completed | Katowice, 40-635, Poland | |
Withdrawn | Breclav, 690 74, Czech Republic | |
Completed | Changchun, 130021, China | |
Withdrawn | Pittsburgh, 15213-2592, United States | |
Completed | Houston, 77030, United States | |
Completed | Montreal, H2L 4M1, Canada | |
Completed | Thunder Bay, P7K 0A4, Canada | |
Completed | Herlev, 2730, Denmark | |
Completed | Meerbusch, 40670, Germany | |
Completed | Krasnoyarsk, 660022, Russia | |
Completed | Colchester, CO4 5JR, United Kingdom | |
Completed | Yeovil, BA21 4AT, United Kingdom | |
Completed | Sunderland, SR4 7TP, United Kingdom | |
Completed | Leicester, LE2 7LX, United Kingdom | |
Completed | El Palmar (Murcia), 30120, Spain | |
Terminated (Halted Prematurely) | Ciudad Auton. de Buenos Aires, C1425DND, Argentina | |
Completed | London, N6G 2V4, Canada | |
Completed | Wien, 1020, Austria | |
Completed | Feldbach, 8330, Austria | |
Completed | Sheffield, S10 2JF, United Kingdom | |
Withdrawn | Bristol, BS10 5NB, United Kingdom | |
Completed | Taunton, TA1 5DA, United Kingdom | |
Completed | Durham, DH1 5TW, United Kingdom | |
Withdrawn | BONHEIDEN, 2820, Belgium | |
Completed | Tel Aviv, 6423906, Israel | |
Completed | Haifa, 3339419, Israel | |
Completed | Ashkelon, 7827804, Israel | |
Completed | Jerusalem, Israel | |
Completed | Ramat Gan, 5262000, Israel | |
Completed | Salzburg, 5020, Austria | |
Withdrawn | Nanjing, 210002, China | |
Withdrawn | Beijing, 100038, China | |
Completed | Shanghai, 200032, China | |
Completed | Shijiazhuang, 050000, China | |
Completed | Changsha, 410008, China | |
Completed | Tianjin, 300052, China | |
Withdrawn | Wuhan, 430030, China | |
Withdrawn | Xi'an, 710032, China | |
Withdrawn | Wuhan, 430022, China | |
Completed | Nantong, 226001, China | |
Completed | Guangzhou, 510080, China | |
Withdrawn | Dalian, 116027, China | |
Completed | Harbin, China | |
Completed | Milton Keynes, MK6 5LD, United Kingdom | |
Completed | St. Petersburg, 194354, Russia | |
Completed | Tomsk, 634063, Russia | |
Completed | Bern, 3010, Switzerland | |
Completed | Genève, 1205, Switzerland | |
Completed | Baden, 5404, Switzerland | |
Completed | Vaasa, 65130, Finland | |
Completed | Konya, 42075, Turkey | |
Completed | Seoul, 130-872, Korea, Republic Of | |
Completed | Daegu, 42415, Korea, Republic Of | |
Completed | PARIS cedex 14, 75674, France | |
Completed | CAEN CEDEX, 14033, France | |
Completed | LIMOGES, 87042, France | |
Completed | Ankara, 06500, Turkey | |
Completed | Istanbul, 34098, Turkey | |
Completed | Mannheim, 68167, Germany | |
Completed | Gdansk, 80-952, Poland | |
Completed | Morelia, 58000, Mexico | |
Withdrawn | Exeter, EX2 5DW, United Kingdom | |
Withdrawn | Eskisehir, 26480, Turkey | |
Completed | Vyskov, 682 01, Czech Republic | |
Completed | Hradec Kralove, 500 05, Czech Republic | |
Withdrawn | Middlesborough, TS4 3BW, United Kingdom | |
Withdrawn | Glasgow, G51 4TG, United Kingdom | |
Completed | Verona, 37024, Italy | |
Completed | Sevilla, 41013, Spain | |
Withdrawn | Jönköping, 551 85, Sweden | |
Completed | Beer Sheva, 8410101, Israel | |
Completed | Haifa, 3436212, Israel | |
Completed | Petah Tikva, 4941492, Israel | |
Completed | Wien, 1090, Austria | |
Withdrawn | Hangzhou, 310003, China | |
Completed | Beijing, 100730, China | |
Withdrawn | Jinan, 250021, China | |
Completed | Zhengzhou, 450052, China | |
Withdrawn | York, YO318HE, United Kingdom | |
Withdrawn | CRETEIL, 94010, France | |
Completed | ANTONY CEDEX, 92166, France | |
Completed | Larissa, 41100, Greece | |
Completed | Thessaloniki, 546 36, Greece | |
Completed | Ioannina, 45500, Greece | |
Completed | Athens, 11528, Greece | |
Withdrawn | Ioannina, 45500, Greece | |
Withdrawn | Athens, 11525, Greece | |
Completed | El Paso, 79905-2709, United States | |
Completed | Cleveland, 44195, United States | |
Withdrawn | Brooklyn, 11203, United States | |
Withdrawn | Cleveland, 44109-1998, United States | |
Completed | Portland, 97225, United States | |
Completed | Stanford, 94305-5119, United States | |
Withdrawn | Ankara, 06100, Turkey | |
Completed | Konya, 42080, Turkey | |
Terminated (Halted Prematurely) | Istanbul, Turkey | |
Completed | Kingston, K7L 2V7, Canada | |
Completed | Antakya, 31000, Turkey | |
Completed | Kahramanmaras, 46000, Turkey | |
Completed | Ankara, 6100, Turkey | |
Completed | Trieste, 34100, Italy | |
Completed | Roma, 00152, Italy | |
Completed | Roma, 00133, Italy | |
Completed | Belo Horizonte, 30150-221, Brazil | |
Completed | Markkleeberg, 04416, Germany | |
Completed | Merida, 97070, Mexico | |
Withdrawn | ANTWERPEN, 2020, Belgium | |
Withdrawn | Athens, 11521, Greece | |
Withdrawn | Athens, 11527, Greece | |
Completed | Athens, 11528, Greece | |
Completed | Athens, 11528, Greece | |
Completed | Athens, 11521, Greece | |
Completed | Torrance, 90502, United States | |
Completed | Dallas, 75390, United States | |
Completed | Cincinnati, 45219, United States | |
Withdrawn | Phoenix, 85028, United States | |
Withdrawn | New York, 10029, United States | |
Completed | Nashville, 37232-5400, United States | |
Withdrawn | Buenos Aires, C1280AEB, Argentina | |
Completed | Margate, CT9 4AN, United Kingdom | |
Withdrawn | Phoenix, 85054, United States | |
Completed | Buffalo, 14203, United States | |
Completed | Long Beach, 90806, United States | |
Completed | Lexington, 40536, United States | |
Completed | Hachioji, 192-0032, Japan | |
Completed | Villach, 9500, Austria | |
Completed | Vöcklabruck, 4840, Austria | |
Completed | St. Pölten, 3100, Austria | |
Completed | Bad Pirawarth, 2222, Austria | |
Withdrawn | Narashino, 275-0026, Japan | |
Completed | Brandon, R7A 2B3, Canada | |
Completed | Belo Horizonte, 30130-100, Brazil | |
Withdrawn | Chapel Hill, 27599-7025, United States | |
Completed | Warszawa, 03-242, Poland | |
Completed | Delegación Gustavo A. Madero, 07760, Mexico | |
Completed | Vila Franca de Xira, P 2600-178, Portugal | |
Completed | Klagenfurt, 9020, Austria | |
Completed | NIMES cedex 9, 30029, France | |
Withdrawn | SAINT-DENIS, 93200, France | |
Completed | BREST CEDEX, 29609, France | |
Withdrawn | Taiyuan, 030001, China | |
Withdrawn | Chongqing, 400010, China | |
Withdrawn | Chengdu, 610041, China | |
Completed | Lappeenranta, FIN-53130, Finland | |
Completed | London, N18 1QX, United Kingdom | |
Withdrawn | Belfast, BT16 1RH, United Kingdom | |
Completed | Boston, PE21 9QS, United Kingdom | |
Completed | Hillerød, 3400, Denmark | |
Completed | Foshan, 528000, China | |
Completed | Kunming, 650032, China | |
Completed | Shenyang, 110016, China | |
Completed | Fuzhou, 350005, China | |
Completed | Chongqing, China | |
Completed | Hangzhou, 310009, China | |
Completed | A Coruña, 15006, Spain | |
Completed | Hakodate, 041-0802, Japan | |
Completed | Nishinomiya, 663-8211, Japan | |
Completed | Hiroshima, 730-8518, Japan | |
Completed | Dresden, 01129, Germany | |
Completed | Santiago, 8420524, Chile | |
Completed | Fribourg, 1700, Switzerland | |
Completed | Taizhou, 317000, China | |
Completed | Baotou, 014010, China | |
Withdrawn | Guangzhou, 510630, China | |
Completed | Wenzhou, 325000, China | |
Completed | Tianjin, 300000, China | |
Completed | Haikou, 570311, China | |
Completed | Xi'an, 710038, China | |
Completed | Guangzhou, 510080, China | |
Completed | Burlington, L7M 4Y1, Canada | |
Completed | Lleida, 25198, Spain | |
Completed | Bilbao, 48013, Spain | |
Completed | Austin, 78701, United States | |
Withdrawn | Athens, 10676, Greece | |
Completed | Qingdao, 266003, China | |
Completed | Wuhan, 430060, China | |
Completed | Feldkirch, 6807, Austria | |
Completed | Sakai, 590-0064, Japan | |
Completed | Fukuoka, 810-0001, Japan | |
Completed | Fukuoka, 811-0213, Japan | |
Completed | Lodz, 90-153, Poland | |
Completed | Volgograd, 400131, Russia | |
Completed | Nizhny Novgorod, 603005, Russia | |
Completed | Kyoto, 601-1495, Japan | |
Completed | Sant Joan Despi, 08970, Spain | |
Completed | Toyota, 471-8513, Japan | |
Completed | St. Petersburg, 191186, Russia | |
Completed | Moscow, 119049, Russia | |
Withdrawn | Penza, 440026, Russia | |
Completed | Wuhan, 430014, China | |
Withdrawn | Shuzhou, 215031, China | |
Completed | Wuhan, 430034, China | |
Completed | Nanchang, 330006, China | |
Completed | Baoji, 721008, China | |
Completed | Zaragoza, 50009, Spain | |
Completed | Launceston, 7250, Australia | |
Completed | Ulyanovsk, 432063, Russia | |
Completed | Leeds, LS1 3EX, United Kingdom | |
Withdrawn | Camberley, GU16 7UJ, United Kingdom | |
Completed | Lanzhou, 730000, China | |
Withdrawn | Changchun, 130000, China | |
Completed | Fuzhou, 350001, China | |
Completed | Guangzhou, China | |
Completed | Temple, 76504, United States | |
Completed | Erie, 16550, United States | |
Withdrawn | Houston, 77030-2707, United States | |
Completed | Yantai, 264000, China | |
Completed | Mount Clemens, 48043, United States | |
Completed | Puerto Montt, 5506667, Chile |
Primary Outcome
- Incidence Rate of the Composite Efficacy Outcome (Adjudicated)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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of a Major Bleeding Event According to the International Society on Thrombosis and Haemostasis (ISTH) Criteria (Adjudicated)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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
Secondary Outcome
- Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial InfarctionIncidence 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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of All-Cause MortalityAll-cause mortality includes all deaths of participants due to any cause.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial InfarctionDisabling 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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of Life-Threatening Bleeding EventsLife-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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of Clinically Relevant Non-Major Bleeding EventsNon-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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
- Incidence Rate of Intracranial HemorrhageIntracranial 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.date_rangeTime Frame:From randomization until the efficacy cut-off date (median 326 days)enhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
2