stop_circleTerminated/Withdrawn

Stroke

Bayer Identifier:

16573

ClinicalTrials.gov Identifier:

NCT02313909

EudraCT Number:

2013-000768-27

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

All

Age

50 - N/A
  • - 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)
  • - 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

Trial summary

Enrollment Goal
7213
Trial Dates
December 2014 - February 2018
Phase
Phase 3
Could I Receive a placebo
Yes
Products
Xarelto (Rivaroxaban, BAY59-7939)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
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_encryption
    Safety Issue:
    No
  • 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_encryption
    Safety Issue:
    No

Secondary Outcome

  • Incidence Rate of Any of the Following: Cardiovascular Death, Recurrent Stroke, Systemic Embolism and Myocardial Infarction
    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.
    date_rangeTime Frame:
    From randomization until the efficacy cut-off date (median 326 days)
    enhanced_encryption
    Safety Issue:
    No
  • Incidence Rate of All-Cause Mortality
    All-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_encryption
    Safety Issue:
    No
  • Incidence Rate of the Following: Stroke, Ischemic Stroke, Disabling Stroke, Cardiovascular (CV) Death, Myocardial Infarction
    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.
    date_rangeTime Frame:
    From randomization until the efficacy cut-off date (median 326 days)
    enhanced_encryption
    Safety Issue:
    No
  • Incidence Rate of Life-Threatening Bleeding Events
    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.
    date_rangeTime Frame:
    From randomization until the efficacy cut-off date (median 326 days)
    enhanced_encryption
    Safety Issue:
    No
  • Incidence Rate of Clinically Relevant Non-Major Bleeding Events
    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.
    date_rangeTime Frame:
    From randomization until the efficacy cut-off date (median 326 days)
    enhanced_encryption
    Safety Issue:
    No
  • Incidence Rate of Intracranial Hemorrhage
    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.
    date_rangeTime Frame:
    From randomization until the efficacy cut-off date (median 326 days)
    enhanced_encryption
    Safety Issue:
    No

Trial design

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
Trial Type
Interventional
Intervention Type
Drug
Trial Purpose
Prevention
Allocation
Randomized
Blinding
Double Blind
Assignment
Parallel Assignment
Trial Arms
2

Additional Information

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