A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel (AXIOMATIC-SSP)

June 8, 2023 updated by: Bristol-Myers Squibb

A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study of BMS-986177, an Oral Factor XIa Inhibitor, for the Prevention of New Ischemic Stroke or New Covert Brain Infarction in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA)

The purpose of this clinical study is to determine whether the addition of an oral Factor XIa Inhibitor to Aspirin and Clopidogrel is more effective than standard therapy in secondary stroke prevention.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2366

Phase

  • Phase 2

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
      • Buenos Aires, Argentina, 1437
        • Local Institution
      • Buenos Aires, Argentina, C1425DND
        • Local Institution - 0068
      • Buenos Aires, Argentina, C1425
        • Local Institution
      • Santa Fe, Argentina, 3000
        • Local Institution
    • Buenos Aires
      • Adrogué, Buenos Aires, Argentina, B1846DSK
        • Local Institution - 0100
      • Caba, Buenos Aires, Argentina, C1199ABB
        • Local Institution - 0063
      • Caba, Buenos Aires, Argentina, C1428AQK
        • Local Institution - 0076
      • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1180AAX
        • Local Institution - 0067
      • Lomas de Zamora, Buenos Aires, Argentina, 1832
        • Local Institution - 0237
      • Recoleta, Buenos Aires, Argentina, C1115AAB
        • Local Institution - 0435
  • Australia
    • New South Wales
      • Randwick, New South Wales, Australia, 2031
        • Local Institution - 0329
      • Sydney, New South Wales, Australia, 2170
        • Local Institution - 0360
    • Queensland
      • Southport, Queensland, Australia, 4215
        • Local Institution - 0287
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Local Institution - 0399
    • Tasmania
      • Launceston, Tasmania, Australia, 7250
        • Local Institution - 0397
    • Victoria
      • Clayton, Victoria, Australia, 3168
        • Local Institution - 0358
      • Heidelberg, Victoria, Australia, 3084
        • Local Institution - 0281
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Local Institution - 0315
  • Austria
      • Klagenfurt Am Woerthersee, Austria, 9020
        • Local Institution - 0184
      • St. Pölten, Austria, 3100
        • Local Institution
      • Vocklabruck, Austria, 4840
        • Local Institution - 0106
      • Wien, Austria, 1160
        • Local Institution - 0273
  • Belgium
      • Brasschaat, Belgium, 2930
        • Local Institution
      • Bruges, Belgium, 8000
        • Local Institution - 0284
      • Brussels, Belgium, 1020
        • Local Institution - 0427
      • Brussels, Belgium, 1200
        • Local Institution - 0190
      • Bruxelles, Belgium, 1070
        • Local Institution - 0305
      • Gent, Belgium, 9000
        • Local Institution - 0199
      • Kortrijk, Belgium, 8500
        • Local Institution - 0103
      • Leuven, Belgium, 3000
        • Local Institution - 0098
      • Liege, Belgium, 4000
        • Local Institution - 0178
    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • Local Institution - 0122
    • Brussels
      • Brussel, Brussels, Belgium, 1090
        • Local Institution - 0196
    • Namur
      • Yvoir, Namur, Belgium, 5530
        • Local Institution - 0192
  • Brazil
    • Ceara
      • Fortaleza, Ceara, Brazil, 60175-295
        • Local Institution - 0072
    • Minas Gerais
      • Uberaba, Minas Gerais, Brazil, 38025-260
        • Local Institution - 0275
    • Parana
      • Curitiba, Parana, Brazil, 80060-900
        • Local Institution - 0314
    • Rio Grande Do Sul
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Local Institution - 0200
    • SAO Paulo
      • Botucatu, SAO Paulo, Brazil, 18618-686
        • Local Institution - 0245
      • Campinas, SAO Paulo, Brazil, 13083-970
        • Local Institution - 0065
      • Ribeirao Preto, SAO Paulo, Brazil, 14051-140
        • Local Institution
      • Santo Andre, SAO Paulo, Brazil, 09030-010
        • Local Institution - 0113
      • São Paulo, SAO Paulo, Brazil, 01221-020
        • Local Institution - 0234
      • São Paulo, SAO Paulo, Brazil, 04024-002
        • Local Institution - 0248
    • Santa Catarina
      • Joinville, Santa Catarina, Brazil, 89202 165
        • Local Institution - 0219
  • Canada
      • Quebec, Canada, G1J 1Z4
        • Local Institution - 0064
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • Local Institution - 0057
      • Edmonton, Alberta, Canada, T6G 2G3
        • Local Institution - 0061
      • Lethbridge, Alberta, Canada, T1J 0N9
        • Local Institution - 0059
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 0E3
        • Local Institution - 0369
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Local Institution - 0121
    • Ontario
      • Hamilton, Ontario, Canada, L8L 2X2
        • Local Institution - 0054
      • Kingston, Ontario, Canada, K7L 2V7
        • Local Institution
      • London, Ontario, Canada, N6A 5A5
        • Local Institution - 0227
      • Toronto, Ontario, Canada, M5B 1W8
        • Local Institution
      • Toronto, Ontario, Canada, M4N 3M5
        • Local Institution - 0124
    • Quebec
      • Chicoutimi, Quebec, Canada, G7H 5H6
        • Local Institution - 0326
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Local Institution - 0155
      • Montreal, Quebec, Canada, H4A3J1
        • Local Institution - 0066
  • Chile
      • Los Angeles, Chile, 441055
        • Local Institution
      • Valdivia, Chile, 5090145
        • Local Institution - 0131
      • Viña del Mar, Chile
        • Local Institution - 0167
    • Valparaiso
      • Viña del Mar, Valparaiso, Chile, 2520612
        • Local Institution - 0172
  • China
    • Beijing
      • Beijing, Beijing, China, 100070
        • Local Institution
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Local Institution
    • Hainan
      • Haikou, Hainan, China, 570311
        • Local Institution
    • Heilongjiang
      • Daqing, Heilongjiang, China, 163001
        • Local Institution
    • Henan
      • Zhengzhou, Henan, China, 450052
        • Local Institution
    • Jiangsu
      • Nantong, Jiangsu, China, 226001
        • Local Institution
      • Yangzhou, Jiangsu, China, 225001
        • Local Institution
    • Jilin
      • Changchun, Jilin, China, 130021
        • Local Institution
    • Liaoning
      • Shenyang, Liaoning, China, 110016
        • Local Institution
    • Shandong
      • Qingdao, Shandong, China, 266000
        • Local Institution
      • YanTai, Shandong, China, 264000
        • Local Institution
    • Zhejiang
      • Wenzhou, Zhejiang, China, 325000
        • Local Institution
  • Czechia
      • Brno, Czechia, 656 91
        • Local Institution
      • Ceske Budejovice, Czechia, 370 87
        • Local Institution
      • Ostrava, Czechia, 703 00
        • Local Institution - 0023
      • Praha 2, Czechia, 128 08
        • Local Institution - 0339
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • Local Institution - 0401
    • Vysocina
      • Jihlava, Vysocina, Czechia, 586 01
        • Local Institution - 0348
  • Denmark
      • Aalborg, Denmark, 9000
        • Local Institution - 0217
      • Aarhus N, Denmark, 8200
        • Local Institution - 0127
      • Copenhagen, Denmark, 2400
        • Local Institution - 0142
      • Glostrup, Denmark, 2600
        • Local Institution - 0110
    • Capital
      • Herlev, Capital, Denmark, 2730
        • Local Institution - 0117
  • Finland
      • Helsinki, Finland, 290
        • Local Institution - 0111
      • Lappeenranta, Finland, 53130
        • Local Institution - 0341
      • Turku, Finland, FI-20520
        • Local Institution - 0143
  • France
      • Bordeaux, France, 33000
        • Local Institution - 0051
      • Bourg-en-Bresse, France, 01012
        • Local Institution
      • Brest, France, 29200
        • Local Institution - 0165
      • Caen, France, 14033
        • Local Institution - 0174
      • Créteil, France, 94010
        • Local Institution
      • Limoges Cedex, France, 87042
        • Local Institution
      • Marseille, France, 13385
        • Local Institution - 0168
      • Nancy, France, 54035
        • Local Institution - 0297
      • Nimes, France, 30029
        • Local Institution - 0205
      • Paris, France, 75013
        • Local Institution
      • Paris, France, 75010
        • Local Institution - 0049
      • Paris, France, 75019
        • Local Institution - 0126
      • Paris, France, 75877
        • Local Institution - 0028
      • Rouen Cedex, France, 76031
        • Local Institution - 0107
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0355
    • Hérault
      • Montpellier, Hérault, France, 34295
        • Local Institution - 0442
    • Nord
      • Lille, Nord, France, 59037
        • Local Institution - 0048
  • Germany
      • Altenburg, Germany, 04600
        • Local Institution - 0011
      • Berlin, Germany, 12203
        • Local Institution - 0032
      • Berlin, Germany, 12351
        • Local Institution
      • Bielefeld, Germany, 33617
        • Local Institution
      • Bonn, Germany, 53127
        • Local Institution - 0250
      • Bremen, Germany, 28755
        • Local Institution - 0380
      • Dresden, Germany, 01307
        • Local Institution - 0144
      • Erlangen, Germany, 91054
        • Local Institution - 0097
      • Essen, Germany, 45131
        • Local Institution - 0053
      • Frankfurt am Main, Germany, 60528
        • Local Institution - 0291
      • Gießen, Germany, 35392
        • Local Institution - 0254
      • Hamburg, Germany, 20246
        • Local Institution - 0056
      • Hamburg, Germany, 22043
        • Local Institution - 0044
      • Hamburg, Germany, 22763
        • Local Institution - 0034
      • Hannover, Germany, D30625
        • Local Institution
      • Heidelberg, Germany, 69120
        • Local Institution - 0055
      • Magdeburg, Germany, 39120
        • Local Institution
      • Minden, Germany, 32429
        • Local Institution - 0036
      • Münster, Germany, 48149
        • Local Institution - 0256
      • Osnabruck, Germany, 49076
        • Local Institution - 0378
      • Regensburg, Germany, 93053
        • Local Institution - 0367
      • Sande, Germany, 26452
        • Local Institution - 0387
      • Siegen, Germany, 57076
        • Local Institution
      • Ulm, Germany, 89081
        • Local Institution - 0241
    • Baden-Württemberg
      • Sindelfingen, Baden-Württemberg, Germany, 71065
        • Local Institution - 0391
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Local Institution - 0045
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 65929
        • Local Institution - 0285
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Local Institution - 0090
    • Schleswig-Holstein
      • Lübeck, Schleswig-Holstein, Germany, 23538
        • Local Institution - 0258
  • Greece
      • Athens, Greece, 11527
        • Local Institution
      • Athens, Greece, 106 76
        • Local Institution - 0370
      • Athens, Greece, 11525
        • Local Institution - 0436
      • Athens, Greece, 11526
        • Local Institution - 0440
      • Athens, Greece, 11527
        • Local Institution - 0373
      • Athens, Greece, 11528
        • Local Institution - 0209
      • Athens, Greece, 11528
        • Local Institution - 0283
      • Athens, Greece, 12461
        • Local Institution - 0351
      • Crete, Greece, 71110
        • Local Institution - 0407
      • Ioannina, Greece, 45445
        • Local Institution
      • Larissa, Greece, 41110
        • Local Institution - 0161
      • Larissa, Greece, 41221
        • Local Institution - 0441
      • Loanniana, Greece, 45500
        • Local Institution - 0333
      • Loanniana, Greece, 45500
        • Local Institution - 0365
      • Neo Faliro, Greece, 18547
        • Local Institution - 0439
      • Patras, Greece, 26500
        • Local Institution - 0371
      • Pireaus, Greece, 18536
        • Local Institution - 0208
      • Thessaloniki, Greece, 54621
        • Local Institution - 0405
      • Thessaloniki, Greece, 54636
        • Local Institution - 0269
      • Thessaloniki, Greece, 54636
        • Local Institution - 0389
      • Thessaloniki, Greece, 54642
        • Local Institution - 0444
      • Thessaloniki, Greece, 56403
        • Local Institution - 0210
      • Thessaloniki, Greece, 57010
        • Local Institution - 0445
    • Attiki
      • Athina, Attiki, Greece, 115 21
        • Local Institution - 0438
    • Larisa
      • Larissa, Larisa, Greece, 41110
        • Local Institution - 0357
  • Hong Kong
      • Hong Kong, Hong Kong
        • Local Institution
  • Hungary
      • Budapest, Hungary, 1083
        • Local Institution - 0134
      • Budapest, Hungary, 1106
        • Local Institution - 0077
      • Budapest, Hungary, 1134
        • Local Institution - 0119
      • Budapest, Hungary, 1145
        • Local Institution - 0136
      • Debrecen, Hungary, 4032
        • Local Institution - 0154
      • Gyor, Hungary, 9024
        • Local Institution - 0079
      • Kistarcsa, Hungary, 02143
        • Local Institution - 0175
      • Kisvárda, Hungary, 4600
        • Local Institution - 0437
      • Nyíregyháza, Hungary, 4400
        • Local Institution - 0220
      • Pecs, Hungary, 7624
        • Local Institution - 0138
      • Szeged, Hungary, 6725
        • Local Institution - 0133
      • Zalaegerszeg, Hungary, 8900
        • Local Institution - 0137
    • BZ
      • Miskolc, BZ, Hungary, 3526
        • Local Institution - 0070
  • Israel
      • Beer-Sheva, Israel, 85025
        • Local Institution
      • Haifa, Israel, 3109601
        • Local Institution - 0139
      • Haifa, Israel, 34362
        • Local Institution - 0349
      • Jerusalem, Israel, 91031
        • Local Institution
      • Jerusalem, Israel, 9103102
        • Local Institution - 0193
      • Jerusalem, Israel, 91120
        • Local Institution - 0078
      • Nahariya, Israel, 22100
        • Local Institution - 0308
      • Petah Tikva, Israel, 49100
        • Local Institution - 0247
      • Ramat-Gan, Israel, 52621
        • Local Institution - 0204
      • Tel Aviv, Israel, 64239
        • Local Institution - 0086
  • Italy
      • Bologna, Italy, 40133
        • Local Institution - 0156
      • Cagliari, Italy, 09134
        • Local Institution - 0290
      • Milano, Italy, 20132
        • Local Institution - 0095
      • Modena, Italy, 1355-41126
        • Local Institution - 0104
      • Perugia, Italy, 06012
        • Local Institution - 0085
      • Perugia, Italy, 06129
        • Local Institution - 0114
      • Roma, Italy, 00152
        • Local Institution - 0108
      • Roma, Italy, 00161
        • Local Institution - 0129
      • Verona, Italy, 37126
        • Local Institution - 0083
      • Vibo Valentia, Italy, 89900
        • Local Institution - 0123
    • Liguria
      • Genova, Liguria, Italy, 16132
        • Local Institution - 0359
    • Lombardia
      • Pavia, Lombardia, Italy, 27100
        • Local Institution - 0084
    • Marche
      • Ancona, Marche, Italy, 60020
        • Local Institution - 0151
    • Veneto
      • Negrar, Veneto, Italy, 37024
        • Local Institution - 0149
  • Japan
      • Fukuoka, Japan, 810-0001
        • Local Institution - 0271
      • Fukuoka, Japan, 810-8563
        • Local Institution - 0243
      • Kyoto, Japan, 6008558
        • Local Institution - 0312
      • Osaka, Japan, 533-0024
        • Local Institution - 0327
      • Osaka, Japan, 540-0006
        • Local Institution - 0239
      • Osaka, Japan, 558-8558
        • Local Institution - 0313
      • Saga, Japan, 849-8501
        • Local Institution - 0301
    • Aichi
      • Kasugai, Aichi, Japan, 487-0016
        • Local Institution - 0335
      • Nagoya-shi, Aichi, Japan, 4600001
        • Local Institution - 0274
      • Toyoake Shi, Aichi, Japan, 4701192
        • Local Institution - 0331
      • Toyohashi-shi, Aichi, Japan, 440-8510
        • Local Institution - 0325
      • Toyota-shi, Aichi, Japan, 471-8513
        • Local Institution - 0317
    • Chiba
      • Sakura-shi, Chiba, Japan, 285-8741
        • Local Institution - 0336
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8516
        • Local Institution - 0320
      • Kasuga-shi, Fukuoka, Japan, 816-0864
        • Local Institution - 0259
      • Kitakyushu, Fukuoka, Japan, 800-0296
        • Local Institution - 0311
      • Kitakyushu-shi, Fukuoka, Japan, 802-8555
        • Local Institution - 0229
      • Kitakyushu-shi, Fukuoka, Japan, 8058508
        • Local Institution - 0270
      • Koga-shi, Fukuoka, Japan, 811-3113
        • Local Institution - 0230
      • Kurume City, Fukuoka, Japan, 830-8577
        • Local Institution - 0324
    • Fukushima
      • Aizuwakamatsu-shi, Fukushima, Japan, 9658585
        • Local Institution - 0257
    • Gifu
      • Takayama-shi, Gifu, Japan, 506-8550
        • Local Institution - 0309
    • Gunma
      • Isesaki-shi, Gunma, Japan, 372-0006
        • Local Institution - 0211
    • Hiroshima
      • Aki-gun, Hiroshima, Japan, 735-8585
        • Local Institution - 0337
      • Higashihiroshima-shi, Hiroshima, Japan, 739-0041
        • Local Institution - 0240
      • Hiroshima-shi, Hiroshima, Japan, 731-0293
        • Local Institution - 0328
    • Hyogo
      • Kobe-City, Hyogo, Japan, 650-0047
        • Local Institution - 0226
    • Ishikawa
      • Kanazawa, Ishikawa, Japan, 920-8650
        • Local Institution - 0323
      • Komatsu, Ishikawa, Japan, 923-8560
        • Local Institution - 0446
    • Kagoshima
      • Kagoshima-shi, Kagoshima, Japan, 890-8760
        • Local Institution - 0299
    • Kanagawa
      • Kawasaki, Kanagawa, Japan, 211-0063
        • Local Institution - 0310
      • Kawasaki-city, Kanagawa, Japan, 216-8511
        • Local Institution - 0228
    • Miyagi
      • Sendai, Miyagi, Japan, 9838520
        • Local Institution - 0278
      • Sendai-shi, Miyagi, Japan, 982-8523
        • Local Institution - 0296
    • Nagasaki
      • Nagasaki-shi, Nagasaki, Japan, 8528501
        • Local Institution - 0261
    • Osaka
      • Izumisano-shi, Osaka, Japan, 5988577
        • Local Institution - 0272
      • Kishiwada, Osaka, Japan, 596-8522
        • Local Institution
      • Matsubara, Osaka, Japan, 580-0032
        • Local Institution - 0279
      • Sakai-shi, Osaka, Japan, 590-0064
        • Local Institution - 0322
      • Suita, Osaka, Japan, 5648565
        • Local Institution - 0251
      • Suita-shi, Osaka, Japan, 565-0871
        • Local Institution - 0244
    • Saitama
      • Hidaka, Saitama, Japan, 858+6
        • Local Institution - 0263
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 3290498
        • Local Institution - 0334
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8603
        • Local Institution - 0232
      • Hachioji, Tokyo, Japan, 192-0032
        • Local Institution - 0343
      • Meguro-ku, Tokyo, Japan, 152-8902
        • Local Institution - 0255
      • Minato-ku, Tokyo, Japan, 1058471
        • Local Institution - 0338
      • Minato-ku, Tokyo, Japan, 108-0073
        • Local Institution - 0342
      • Mitaka-shi, Tokyo, Japan, 181-8611
        • Local Institution - 0295
      • Shinagawa-ku, Tokyo, Japan, 141-8625
        • Local Institution - 0298
      • Shinjuku-ku, Tokyo, Japan, 160-8582
        • Local Institution - 0316
      • Tachikawa-shi, Tokyo, Japan, 1900014
        • Local Institution - 0318
    • Yamaguchi
      • Shimonoseki-Shi, Yamaguchi, Japan, 752-8510
        • Local Institution - 0319
  • Korea, Republic of
      • Anyang, Korea, Republic of, 431-070
        • Local Institution - 0081
      • Busan, Korea, Republic of, 49241
        • Local Institution - 0166
      • Busan, Korea, Republic of, 49201
        • Local Institution - 0109
      • Daegu, Korea, Republic of, 700-712
        • Local Institution
      • Daegu, Korea, Republic of, 41944
        • Local Institution - 0179
      • Daegu, Korea, Republic of, 42415
        • Local Institution - 0102
      • Gwangju, Korea, Republic of, 61469
        • Local Institution - 0105
      • Incheon, Korea, Republic of, 22332
        • Local Institution - 0101
      • Seongnam-si, Korea, Republic of, 13620
        • Local Institution - 0153
      • Seoul, Korea, Republic of, 01830
        • Local Institution - 0087
      • Seoul, Korea, Republic of, 02447
        • Local Institution - 0185
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0071
      • Seoul, Korea, Republic of, 03722
        • Local Institution - 0080
      • Seoul, Korea, Republic of, 04763
        • Local Institution - 0120
      • Seoul, Korea, Republic of, 06273
        • Local Institution - 0145
      • Seoul, Korea, Republic of, 07061
        • Local Institution - 0152
      • Seoul, Korea, Republic of, 08308
        • Local Institution - 0112
      • Seoul, Korea, Republic of, 130-710
        • Local Institution - 0091
    • Gyeonggido
      • Goyang-si, Gyeonggido, Korea, Republic of, 10380
        • Local Institution - 0094
    • Seoul Teugbyeolsi
      • Seoul, Seoul Teugbyeolsi, Korea, Republic of, 05505
        • Local Institution - 0088
  • Mexico
      • Durango, Mexico, 34217
        • Local Institution - 0366
    • Distrito Federal
      • Ciudad de Mexico, Distrito Federal, Mexico, 14080
        • Local Institution
      • Mexico, Distrito Federal, Mexico, 14269
        • Local Institution - 0398
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
        • Local Institution - 0396
    • Nuevo LEON
      • Monterrey, Nuevo LEON, Mexico, 64460
        • Local Institution - 0404
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
        • Local Institution - 0394
  • Norway
      • Bergen, Norway, 5021
        • Local Institution - 0368
      • Grålum, Norway, 1714
        • Local Institution - 0383
      • Kristiansand, Norway, 4604
        • Local Institution
      • Lørenskog, Norway, 1478
        • Local Institution - 0130
      • Oslo, Norway, 0424
        • Local Institution - 0408
      • Stavanger, Norway, 4068
        • Local Institution - 0330
  • Poland
      • Bydgoszcz, Poland, 85-094
        • Local Institution - 0350
      • Chelm, Poland, 22-100
        • Local Institution - 0216
      • Gdansk, Poland, 80-803
        • Local Institution - 0206
      • Grodzisk Mazowieciki, Poland, 05-825
        • Local Institution - 0181
      • Katowice, Poland, 40-635
        • Local Institution - 0253
      • Konskie, Poland, 26-200
        • Local Institution
      • Lodz, Poland, 93-113
        • Local Institution - 0197
      • Olsztyn, Poland, 10-561
        • Local Institution - 0198
      • Sandomierz, Poland, 27-600
        • Local Institution - 0215
      • Skarzysko-Kamienna, Poland, 26-110
        • Local Institution - 0183
      • Walcz, Poland, 78-600
        • Local Institution - 0225
      • Warszawa, Poland, 02-097
        • Local Institution
      • Warszawa, Poland, 02-957
        • Local Institution - 0214
      • Wejherowo, Poland, 84-200
        • Local Institution - 0212
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 04-141
        • Local Institution - 0265
  • Russian Federation
      • Barnaul, Russian Federation, 656038
        • Local Institution - 0277
      • Kemerovo, Russian Federation, 650002
        • Local Institution - 0260
      • Moscow, Russian Federation, 125367
        • Local Institution
      • Moscow, Russian Federation, 117593
        • Local Institution - 0306
      • Novosibirsk, Russian Federation, 630087
        • Local Institution - 0268
      • Smolensk, Russian Federation, 214018
        • Local Institution - 0202
      • St. Petersburg, Russian Federation, 194354
        • Local Institution - 0356
      • Yaroslavl, Russian Federation, 150030
        • Local Institution
  • Spain
      • A Coruna, Spain, 15006
        • Local Institution - 0141
      • Albacete, Spain, 02006
        • Local Institution - 0026
      • Badalona, Spain, 08916
        • Local Institution - 0052
      • Barcelona, Spain, 08003
        • Local Institution - 0012
      • Barcelona, Spain, 08036
        • Local Institution - 0027
      • Barcelona, Spain, 08035
        • Local Institution - 0010
      • Córdoba, Spain, 14004
        • Local Institution - 0385
      • Girona, Spain, 17007
        • Local Institution - 0426
      • L'Hospitalet de Llobregat, Spain, 08907
        • Local Institution - 0176
      • Lleida, Spain, 25008
        • Local Institution - 0249
      • Madrid, Spain, 28007
        • Local Institution - 0238
      • Madrid, Spain, 28034
        • Local Institution - 0025
      • Madrid, Spain, 28041
        • Local Institution - 0413
      • Madrid, Spain, 28046
        • Local Institution - 0384
      • San Sebastian, Spain, 20014
        • Local Institution - 0400
      • Santiago de Compostela, Spain, 15706
        • Local Institution - 0425
      • Sevilla, Spain, 41009
        • Local Institution - 0158
      • Sevilla, Spain, 41013
        • Local Institution - 0177
      • Tarragona, Spain, 43005
        • Local Institution - 0164
      • Terrassa, Spain, 08222
        • Local Institution - 0150
      • Valencia, Spain, 46026
        • Local Institution - 0147
      • Valladolid, Spain, 47005
        • Local Institution - 0014
      • Vigo, Spain, 36312
        • Local Institution - 0418
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Local Institution - 0159
      • Sant Joan Despi, Barcelona, Spain, 08970
        • Local Institution - 0163
    • Castilla Y León
      • León, Castilla Y León, Spain, 24071
        • Local Institution - 0372
  • Sweden
      • Göteborg, Sweden, SE-43146
        • Local Institution - 0171
      • Hassleholm, Sweden, 28125
        • Local Institution - 0191
      • Umea, Sweden, 901 87
        • Local Institution - 0224
      • Uppsala, Sweden, SE-752 37
        • Local Institution - 0132
    • Skane Lan
      • Malmö, Skane Lan, Sweden, SE-205 02
        • Local Institution - 0128
  • Switzerland
      • Aarau, Switzerland, 5001
        • Local Institution - 0162
      • Geneve, Switzerland, 1205
        • Local Institution - 0203
      • Lausanne, Switzerland, 1011
        • Local Institution - 0201
      • Zurich, Switzerland, 8032
        • Local Institution
    • Basel-Stadt (de)
      • Basel, Basel-Stadt (de), Switzerland, 4031
        • Local Institution - 0118
    • Bern (de)
      • Bern, Bern (de), Switzerland, 3010
        • Local Institution - 0115
  • United Kingdom
      • Aberdeen, United Kingdom, AB25 2ZD
        • Local Institution - 0140
      • Ashford, United Kingdom, TN24 0LZ
        • Local Institution
      • Bath, United Kingdom, BA1 3NG
        • Local Institution - 0157
      • Chester, United Kingdom, CH2 1UL
        • Local Institution - 0089
      • Edinburgh, United Kingdom, EH16 4SA
        • Local Institution - 0221
      • Glasgow, United Kingdom, G51 4TF
        • Local Institution - 0096
      • Lancashire, United Kingdom, BL9 7TD
        • Local Institution - 0361
      • London, United Kingdom, SE5 9RF
        • Local Institution
      • London, United Kingdom, W1T 7HA
        • Local Institution
      • Luton, United Kingdom, LU4 0DZ
        • Local Institution - 0303
      • Nottingham, United Kingdom, NG5 1PB
        • Local Institution
      • Salford, United Kingdom, M6 8HD
        • Local Institution - 0431
      • Sheffield, United Kingdom, S10 2JF
        • Local Institution - 0414
      • Staffordshire, United Kingdom, ST4 6QG
        • Local Institution - 0307
    • Kent
      • Canterbury, Kent, United Kingdom, CT1 3NG
        • Local Institution - 0222
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Local Institution - 0029
    • California
      • Glendale, California, United States, 91206
        • Local Institution - 0007
      • Long Beach, California, United States, 90806
        • Local Institution - 0006
      • Los Angeles, California, United States, 90027
        • Kaiser Permanente Los Angeles Medical Center
      • Los Angeles, California, United States, 90095
        • Local Institution - 0231
      • Sacramento, California, United States, 95817
        • Local Institution - 0376
      • Stanford, California, United States, 94305
        • Local Institution - 0004
      • Torrance, California, United States, 90502
        • Local Institution - 0042
    • Delaware
      • Newark, Delaware, United States, 19713
        • Local Institution - 0340
    • Florida
      • Gainesville, Florida, United States, 32610
        • Local Institution - 0075
      • Sarasota, Florida, United States, 34239
        • Local Institution - 0013
      • Tampa, Florida, United States, 33606
        • Local Institution - 0024
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Local Institution - 0015
    • Hawaii
      • Honolulu, Hawaii, United States, 96813
        • Local Institution - 0428
    • Illinois
      • Chicago, Illinois, United States, 60612
        • University of Illinois Hospital & Health Sciences System
      • Chicago, Illinois, United States, 60612
        • Local Institution - 0293
      • Elk Grove Village, Illinois, United States, 60007
        • Local Institution - 0430
      • Rockford, Illinois, United States, 61114
        • Local Institution - 0382
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Local Institution - 0346
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Local Institution - 0047
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Local Institution - 0420
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Local Institution
      • Boston, Massachusetts, United States, 02215
        • Local Institution - 0236
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Local Institution
      • Detroit, Michigan, United States, 48202
        • Local Institution - 0434
      • Detroit, Michigan, United States, 48235
        • Local Institution
      • Farmington Hills, Michigan, United States, 48334
        • Local Institution - 0375
    • Minnesota
      • Minneapolis, Minnesota, United States, 55415
        • Local Institution
    • Missouri
      • Kansas City, Missouri, United States, 64111
        • Local Institution
      • Saint Louis, Missouri, United States, 63104
        • Local Institution
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0294
      • Saint Louis, Missouri, United States, 63110
        • Local Institution - 0352
    • Montana
      • Great Falls, Montana, United States, 59405
        • Advanced Neurology Specialists PLLC
    • New Jersey
      • Camden, New Jersey, United States, 08103
        • Local Institution - 0276
      • New Brunswick, New Jersey, United States, 08901
        • Local Institution - 0039
    • New York
      • Brooklyn, New York, United States, 11203
        • Local Institution - 0354
      • Buffalo, New York, United States, 14202
        • Local Institution
      • New York, New York, United States, 10016
        • Local Institution
      • New York, New York, United States, 10032
        • Local Institution - 0125
    • North Carolina
      • Butner, North Carolina, United States, 27509-1626
        • Duke University Medical Center
      • Chapel Hill, North Carolina, United States, 27599
        • Local Institution - 0043
      • Greensboro, North Carolina, United States, 27405
        • Local Institution - 0016
      • Winston-Salem, North Carolina, United States, 27157
        • Local Institution
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Local Institution - 0003
      • Cleveland, Ohio, United States, 44195
        • Local Institution - 0050
      • Columbus, Ohio, United States, 43210
        • Local Institution - 0419
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Local Institution - 0218
    • Oregon
      • Portland, Oregon, United States, 97239-3011
        • Local Institution - 0022
    • Pennsylvania
      • Abington, Pennsylvania, United States, 19001
        • Local Institution - 0302
      • Allentown, Pennsylvania, United States, 18103-6381
        • Local Institution
      • Camp Hill, Pennsylvania, United States, 17011
        • Local Institution
      • Erie, Pennsylvania, United States, 16550-0001
        • Local Institution - 0018
      • Philadelphia, Pennsylvania, United States, 19140
        • Temple University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Local Institution - 0020
      • York, Pennsylvania, United States, 17403
        • Local Institution - 0019
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Local Institution - 0041
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6307
        • Local Institution - 0009
    • Texas
      • Austin, Texas, United States, 78712
        • Local Institution - 0008
      • Dallas, Texas, United States, 75321
        • Neurology Consultants of Dallas, PA
      • Dallas, Texas, United States, 75390-88520
        • Local Institution
      • El Paso, Texas, United States, 79905
        • University Medical Center of El Paso
      • Houston, Texas, United States, 77030
        • Local Institution - 0040
      • Houston, Texas, United States, 77030
        • Local Institution - 0093
      • Temple, Texas, United States, 76508
        • Local Institution - 0187
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Local Institution
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Local Institution

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

38 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Male and Female ≥40 years of age
  • Acute Ischemic Stroke or Transient Ischemic Attack
  • Intracranial or Extracranial Atherosclerotic Plaque proximal to the affected brain area

Exclusion Criteria:

  • Predicted inability to swallow study medication
  • Any condition that, in the opinion of the Investigator, contraindicates anticoagulant therapy or would have an unacceptable risk of bleeding
  • Use of thrombolytic therapy or mechanical thrombectomy for treatment of index stroke

Other protocol defined inclusion/exclusion criteria could apply

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
Placebo Comparator: BMS-986177 Placebo
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Other: Placebo
Oral Administration
Drug: Clopidogrel
Oral administration
Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration
Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel
Specified Dose on Specified Days
Drug: Aspirin
Oral administration
Drug: Clopidogrel
Oral administration
Drug: BMS-986177
Oral administration

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Model Based Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
Time Frame: From randomization to up to 90 days after randomization
Model based assessment estimate for composite event is a customized statistical analysis called MCP-MOD (Multiple Comparison Procedures, MODel) estimation, which is used to check for dose-response relationship. 95% confidence interval (CI) for composite event based on bootstrap (10000 samples).
From randomization to up to 90 days after randomization

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Major Bleeding According to BARC Type 3 and 5
Time Frame: From first dose to up to 107 days after first dose

Percent of participants with major bleeding based on the Bleeding Academic Research Consortium (BARC) Types 3 and 5 definitions. BARC bleeding types:

3a = Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL transfusion with overt bleeding 3b = Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring IV vasoactive agents 3c = Intracranial hemorrhage, 5a = Probable fatal bleeding 5b = Definite fatal bleeding
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on BARC Types 1-5
Time Frame: From first dose to up to 107 days after first dose
Number of participants with bleeding based on Bleeding Academic Research Consortium (BARC) Type 1 to 5. BARC bleeding types: 0=No bleeding. 1=Not actionable bleeding. 2=Overt, actionable sign of hemorrhage requiring nonsurgical, medical intervention by a health-care professional, leading to hospitalization or increased level of care, or prompting evaluation. 3a=Overt bleeding plus hemoglobin drop of 3 to < 5 g/dL. 3b=Overt bleeding plus hemoglobin drop ≥5 g/dL; cardiac tamponade; bleeding requiring surgical intervention; bleeding requiring IV vasoactive agents. 3c=Intracranial hemorrhage; intraocular bleed compromising vision. 4=CABG-related bleeding, perioperative intracranial bleeding within 48 hours, reoperation after closure of sternotomy to control bleeding, transfusion of ≥5 U whole blood or packed red blood cells within a 48-hour period, chest tube output more than or equal to 2L within a 24-hour period. 5a=Probable fatal bleeding. 5b=Definite fatal bleeding.
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on ISTH-Defined Criteria
Time Frame: From first dose to up to 107 days after first dose
Number of participants with bleeding based on International Society on Thrombosis and Hemostasis (ISTH). ISTH Bleeding Types: 1) Fatal bleeding and/or 2) Symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intraarticular or pericardial, or intramuscular with compartment syndrome and/or 3) Bleeding causing a fall in hemoglobin level of ≥2 g/dL, or leading to transfusion of ≥2 units of whole blood or red cells.
From first dose to up to 107 days after first dose
Number of Participants With Bleeding Based on PLATO-Defined Criteria
Time Frame: From first dose to up to 107 days after first dose

Number of participants with bleeding based on Platelet Inhibition and Patient Outcomes (PLATO) defined criteria. PLATO bleeding definitions:

  1. Major Life-threatening: Fatal, Intracranial, Intrapericardial with cardiac tamponade, Resulting in hypovolemic shock or severe hypotension that requires pressors or surgery, Clinically overt or apparent bleeding associated with decrease in hemoglobin >5 g/dL, Requiring transfusion of ≥4 U whole blood or packed red blood cells (PRBCs)
  2. Other Major: Significantly disabling (eg, intraocular with permanent vision loss), Associated drop in hemoglobin of 3 to 5 g/dL, Requiring transfusion of 2 to 3 U whole blood or PRBCs
  3. Any Major: Any one of the above criteria
  4. Minor: Bleeding that does not meet criteria for PLATO Major bleeding, and requiring medical intervention
From first dose to up to 107 days after first dose
Percent of Participants With Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90
Time Frame: From randomization to up to 90 days after randomization
Descriptive Assessment of Composite of New Ischemic Stroke During Treatment and New Covert Brain Infarction (FLAIR + DWI) Detected by MRI by Day 90.
From randomization to up to 90 days after randomization
Composite of Percent of Participants With New Ischemic Stroke, MI and All Cause Death
Time Frame: From randomization to up to 90 days after randomization
Composite of percent of participants of new ischemic stroke, (Myocardial Infarction) MI and all cause death.
From randomization to up to 90 days after randomization
National Institutes of Health Stroke Scale (NIHSS)
Time Frame: At baseline, on Days 21 and 90, and at the time of a new stroke event
The NIHSS is an 11-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. The score for each ability is a number between 0 and 4, 0 being normal functioning and 4 being completely impaired. The patient's NIHSS score is calculated by adding the number for each element of the scale; 42 is the highest score possible. In the NIHSS, the higher the score, the more impaired a stroke participant is.
At baseline, on Days 21 and 90, and at the time of a new stroke event
Modified Rankin Scale (mRS)
Time Frame: At baseline, on Days 21 and 90, and at the time of a new stroke event

The Modified Rankin Score (mRS) is a 6-point disability scale with possible scores ranging from 0 to 6.

0 = No symptoms at all

  1. = No significant disability despite symptoms; able to carry out all usual duties and activities
  2. = Slight disability; unable to carry out all previous activities, but able to look after own affairs without assistance
  3. = Moderate disability; requiring some help, but able to walk without assistance
  4. = Moderately severe disability; unable to walk and attend to bodily needs without assistance
  5. = Severe disability; bedridden, incontinent and requiring constant nursing care and attention
  6. = Dead
At baseline, on Days 21 and 90, and at the time of a new stroke event
Montreal Cognitive Assessment (MoCA)
Time Frame: At baseline, on Days 21 and 90, and at the time of a new stroke event

The Montreal Cognitive Assessment (MoCA) is a survey with a summed score. MoCA score ranges between a lowest score of 0 to a highest score of 30. A score of:

  • ≥26 points: indicates normal cognitive function
  • 18-25 points: Mild cognitive impairment
  • 10-17 points: Moderate cognitive impairment
  • fewer than 10 points: Severe cognitive impairment
At baseline, on Days 21 and 90, and at the time of a new stroke event
Digit Symbol Substitution Test (DSST)
Time Frame: At baseline, on Days 21 and 90, and at the time of a new stroke event
The Descriptive Summary of the Digit Symbol Substitution Test (DSST) is a scale item, with a lowest score of 0 and highest total score of 135. Higher score indicates better cognitive functioning.
At baseline, on Days 21 and 90, and at the time of a new stroke event
Number of Participants With Adverse Events (AEs)
Time Frame: From first dose to 2 days after last dose of study therapy (up to approximately 107 days)
AE: include all non-serious adverse events with onset on or after first dose date and within 2 days after the last dose of study treatment.
From first dose to 2 days after last dose of study therapy (up to approximately 107 days)
Number of Participants With Clinically Significant Vital Sign Abnormalities
Time Frame: From first dose to up to 90 days after first dose
Number of participants with clinically significant vital sign abnormalities. Vital signs included heart rate and diastolic and systolic blood pressure.
From first dose to up to 90 days after first dose
Number of Participants With Clinically Significant Physical Examination Abnormalities
Time Frame: From first dose to up to 90 days after first dose
Number of participants with clinically significant physical examination abnormalities.
From first dose to up to 90 days after first dose
Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities
Time Frame: From first dose to up to 90 days after first dose
Number of participants with clinically significant ECG abnormalities.
From first dose to up to 90 days after first dose
Number of Participants With Clinically Significant Laboratory Abnormalities - Liver
Time Frame: From first dose to up to approximately 38 months

The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study.

Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
From first dose to up to approximately 38 months
Percent Change From Baseline in aPTT Activity
Time Frame: Baseline and day 90
Percent change from baseline in activated partial thromboplastin time (aPTT) activity via exposure response.
Baseline and day 90
Percent Change From Baseline in Factor XI Clotting Activity
Time Frame: Baseline and day 90
Percent change from baseline in factor XI clotting activity via exposure response.
Baseline and day 90
Pharmacokinetic Parameter - Estimated Clearance (CL)
Time Frame: From first dose to up to 90 days after first dose
Pharmacokinetic Parameter - Estimated Clearance (CL). CL is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.
From first dose to up to 90 days after first dose
Pharmacokinetic Parameter - Volume of the Central Compartment (VC)
Time Frame: From first dose to up to 90 days after first dose
Pharmacokinetic Parameter - Volume of the Central Compartment (VC). VC is derived from plasma concentration versus time data. PK parameters were generated using a Population Pharmacokinetics (PPK) model. Summary statistics for these individual predicted PK parameters and exposures were stratified by dose. The PPK model analysis was based on combined PK data collected on days 1, 21, and 90.
From first dose to up to 90 days after first dose
Volume of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
Time Frame: At day 90
Total volume of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.
At day 90
Number of Incident Infarcts (New DWI+ or DWI- Lesions) by Participant on Day 90 MRI
Time Frame: At day 90
Number of diffusion-weighted imaging (DWI) magnetic resonance imaging (MRI) infarcts on the DWI Sequence on day 90 MRI.
At day 90

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent of Participants With Ischemic Stroke Events
Time Frame: From randomization to up to 90 days after randomization
Secondary analysis of symptomatic ischemic stroke events. Clinical events are included up to day 90. Wald 95% CI within group. Undetermined stroke is included.
From randomization to up to 90 days after randomization

Collaborators and Investigators

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

Sponsor

Bristol-Myers Squibb

Collaborators

Janssen, LP

Investigators

  • Study Director: Bristol-Myers Squibb, Bristol-Myers Squibb

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.

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)

January 27, 2019

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

November 13, 2018

First Submitted That Met QC Criteria

December 5, 2018

First Posted (Actual)

December 6, 2018

Study Record Updates

Last Update Posted (Actual)

June 12, 2023

Last Update Submitted That Met QC Criteria

June 8, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CV010-031

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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