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

Sponsor
Bristol-Myers Squibb (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03766581
Collaborator
Janssen, LP (Industry)
2,366
419
8
38.6
5.6
0.1

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 2

Study Design

Study Type:
Interventional
Actual Enrollment :
2366 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
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)
Actual Study Start Date :
Jan 27, 2019
Anticipated Primary Completion Date :
Apr 9, 2022
Anticipated Study Completion Date :
Apr 16, 2022

Arms and Interventions

Arm Intervention/Treatment
Placebo Comparator: BMS-986177 Placebo

Specified Dose on Specified Days

Other: Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel

Specified Dose on Specified Days

Drug: BMS-986177
Oral administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Outcome Measures

Primary Outcome Measures

  1. Composite of new ischemic stroke during the treatment period and new covert brain infarction (FLAIR + DWI) detected by MRI [Up to 90 days]

Secondary Outcome Measures

  1. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [Up to 90 days]

  2. Event rate based on BARC, International Society on Thrombosis and Hemostasis (ISTH) and Platelet Inhibition and Patient Outcomes (PLATO)-defined criteria [Up to 90 days]

  3. Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [Up to 90 days]

  4. Location of new FLAIR + DWI lesions [Up to 90 days]

  5. Number of new FLAIR + DWI lesions [Up to 90 days]

  6. Volume of new FLAIR + DWI lesions [Up to 90 days]

  7. Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction and all-cause death during the treatment period [Up to 90 days]

  8. Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [Day 21 and Day 90]

  9. Assessment of Neurological function by the modified Rankin Scale (mRS) [Day 21 and Day 90]

  10. Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [Day 21 and Day 90]

  11. Incidence of Adverse Events (AEs) [First dose up to 97 days]

  12. Incidence of Serious Adverse Events (SAEs) [First dose up to 97 days]

  13. Change from Baseline in Heart Rate [Up to 90 Days]

  14. Change from Baseline in Blood Pressure [Up to 90 Days]

  15. Change from Baseline in Respiratory Rate [Up to 90 Days]

  16. Change from Baseline in Body Temperature [Up to 90 Days]

  17. Incidence of Abnormalities in Physical Examination [Up to 90 days]

  18. Incidence of Electrocardiogram (ECG) abnormalities [Up to 90 Days]

  19. Change from baseline in Clinical Laboratory Value of blood [Up to 90 Days]

  20. Change from baseline in Clinical Laboratory Value of Urine [Up to 90 Days]

  21. Change from baseline in Clinical Laboratory Value of Blood Serum [Up to 90 Days]

  22. Change from Baseline in Estimated Clearance (CL) [Up to 90 Days]

  23. Change from Baseline in Volume of Distribution (Vd) [Up to 90 days]

  24. Percent change from baseline in aPTT clotting activity during treatment [Up to 90 Days]

  25. Percent change from baseline in Factor XI clotting activity during treatment [Up to 90 Days]

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham: The Kirklin Clinic Birmingham Alabama United States 35233
2 Glendale Adventist Medical Center Glendale California United States 91206
3 Long Beach Memorial Medical Center Long Beach California United States 90806
4 Kaiser Permanente Los Angeles Medical Center Los Angeles California United States 90027
5 UCLA Ronald Reagan University of California Los Angeles Medical Center Los Angeles California United States 90095
6 UC Davis Health Sacramento California United States 95817
7 Stanford Stroke Center Stanford California United States 94305
8 Harbor UCLA Medical Center Torrance California United States 90502
9 Christiana Care Health System Newark Delaware United States 19718
10 UF Health Neurovascular Hospital Gainesville Florida United States 32610
11 Sarasota Memorial Hospital Sarasota Florida United States 34239
12 University of South Florida Tampa Florida United States 33606
13 Augusta University Augusta Georgia United States 30912
14 The Queens Medical Center Honolulu Hawaii United States 96813
15 University of Illinois at Chicago Chicago Illinois United States 60612
16 University of Illinois Hospital & Health Sciences System Chicago Illinois United States 60612
17 Alexian Brothers Health System Elk Grove Village Illinois United States 60007
18 Mercyhealth Javon Bea Hospital- Riverside Rockford Illinois United States 61114
19 University of Louisville Hospital Louisville Kentucky United States 40202
20 Ochsner Clinic Foundation New Orleans Louisiana United States 70121
21 Sinai Hospital of Baltimore Baltimore Maryland United States 21215
22 Local Institution Boston Massachusetts United States 02118
23 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
24 Local Institution Detroit Michigan United States 48201
25 Henry Ford Hospital Detroit Michigan United States 48202
26 Local Institution Detroit Michigan United States 48235
27 Ascension Providence Hospital - Novi Campus Farmington Hills Michigan United States 48334
28 Local Institution Minneapolis Minnesota United States 55415
29 Local Institution Kansas City Missouri United States 64111
30 Local Institution Saint Louis Missouri United States 63104
31 Barnes Jewish Hospital Saint Louis Missouri United States 63110
32 Washington University School Of Medicine Saint Louis Missouri United States 63110
33 Advanced Neurology Specialists PLLC Great Falls Montana United States 59405
34 Cooper University Hospital Camden New Jersey United States 08103
35 Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
36 SUNY Downstate Health Science University Brooklyn New York United States 11203
37 Local Institution Buffalo New York United States 14202
38 Local Institution New York New York United States 10016
39 Columbia University Medical Center New York New York United States 10032
40 Duke University Medical Center Butner North Carolina United States 27509-1626
41 University of North Carolina at Chapel Hill Chapel Hill North Carolina United States 27599
42 Guilford Neurologic Research, PA Greensboro North Carolina United States 27405
43 Local Institution Winston-Salem North Carolina United States 27157
44 University Hospitals Cleveland Medical Center Cleveland Ohio United States 44106-5055
45 The Cleveland Clinic Foundation Cleveland Ohio United States 44195
46 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
47 INTEGRIS Baptist Medical Center Oklahoma City Oklahoma United States 73112
48 Oregon Health and Science University Portland Oregon United States 97239
49 Abington Memorial Hospital Abington Pennsylvania United States 19001
50 Local Institution Allentown Pennsylvania United States 18103-6381
51 Local Institution Camp Hill Pennsylvania United States 17011
52 UPMC Hamot Erie Pennsylvania United States 16550-0001
53 Hospital of The University of Pennsylvania Philadelphia Pennsylvania United States 19104
54 Temple University Hospital Philadelphia Pennsylvania United States 19140
55 WellSpan York Hospital York Pennsylvania United States 17403
56 Prisma Health-Midlands Columbia South Carolina United States 29203
57 Vanderbilt University Medical Center Nashville Tennessee United States 37232
58 Dell Seton Medical School at The University of Texas - Stroke Institute Austin Texas United States 78701
59 Neurology Consultants of Dallas, PA Dallas Texas United States 75321
60 Local Institution Dallas Texas United States 75390-88520
61 University Medical center of El Paso El Paso Texas United States 79905
62 Methodist Neurological Institute Houston Texas United States 77030
63 University of Texas Health Science Center at Houston Houston Texas United States 77030
64 Baylor Scott and White Research Institute Temple Texas United States 76508
65 Local Institution Richmond Virginia United States 23298
66 Local Institution Milwaukee Wisconsin United States 53226
67 Local Institution Caba Buenos Aires Argentina 1115
68 Local Institution Caba Buenos Aires Argentina C1199ABB
69 Local Institution Caba Buenos Aires Argentina C1428AQK
70 Local Institution Ciudad Autonoma de Buenos Aires Buenos Aires Argentina C1180AAX
71 Local Institution Lomas de Zamora Buenos Aires Argentina 1832
72 Local Institution Buenos Aires Argentina 1437
73 Local Institution Buenos Aires Argentina C1425DND
74 Local Institution Buenos Aires Argentina C1425
75 Local Institution Santa Fe Argentina 3000
76 Local Institution Randwick New South Wales Australia 2031
77 Local Institution Sydney New South Wales Australia 2170
78 Local Institution Southport Queensland Australia 4215
79 Local Institution Adelaide South Australia Australia 5000
80 Local Institution Launceston Tasmania Australia 7250
81 Local Institution Clayton Victoria Australia 3168
82 Local Institution Heidelberg Victoria Australia 3084
83 Local Institution Murdoch Western Australia Australia 6150
84 Local Institution Klagenfurt Am Woerthersee Austria 9020
85 Local Institution St. Pölten Austria 3100
86 Local Institution Vocklabruck Austria 4840
87 Local Institution Wien Austria 1160
88 Local Institution - 0192 Yvoir Namur Belgium 5530
89 Local Institution Brasschaat Belgium 2930
90 Local Institution Bruges Belgium 8000
91 Local Institution Brussels Belgium 1020
92 Local Institution Brussels Belgium 1200
93 Local Institution Brussel Belgium 1090
94 Local Institution Bruxelles Belgium 1070
95 Local Institution Edegem Belgium 2650
96 Local Institution Gent Belgium 9000
97 Local Institution Kortrijk Belgium 8500
98 Local Institution Leuven Belgium 3000
99 Local Institution Liege Belgium 4000
100 Local Institution Fortaleza Ceara Brazil 60175-295
101 Local Institution Uberaba Minas Gerais Brazil 38025-260
102 Local Institution Curitiba Parana Brazil 80060-900
103 Local Institution Porto Alegre Rio Grande Do Sul Brazil 90035-903
104 Local Institution Joinville Santa Catarina Brazil 89202 165
105 Local Institution Botucatu SAO Paulo Brazil 18618-686
106 Local Institution Campinas SAO Paulo Brazil 13083-970
107 Local Institution Ribeirao Preto SAO Paulo Brazil 14051-140
108 Local Institution Santo Andre SAO Paulo Brazil 09030-010
109 Local Institution São Paulo SAO Paulo Brazil 01221-020
110 Local Institution São Paulo SAO Paulo Brazil 04024-002
111 Local Institution Calgary Alberta Canada T2N 4N1
112 Local Institution Edmonton Alberta Canada T6G 2G3
113 Local Institution Lethbridge Alberta Canada T1J 0N9
114 Local Institution New Westminster British Columbia Canada V3L 0E3
115 Local Institution Vancouver British Columbia Canada V5Z 1M9
116 Local Institution Hamilton Ontario Canada L8L 2X2
117 Local Institution Kingston Ontario Canada K7L 2V7
118 Local Institution London Ontario Canada N6A 5A5
119 Local Institution Toronto Ontario Canada M4N 3M5
120 Local Institution Toronto Ontario Canada M5B 1W8
121 Local Institution Chicoutimi Quebec Canada G7H 5H6
122 Local Institution Greenfield Park Quebec Canada J4V 2H1
123 Local Institution Montreal Quebec Canada H4A3J1
124 Local Institution Quebec Canada G1J 1Z4
125 Local Institution Valdivia Los Rios Chile 5090145
126 Local Institution Vina del Mar Valparaiso Chile 2520997
127 Local Institution Los Angeles Chile 441055
128 Local Institution Beijing Beijing China 100070
129 Local Institution Guangzhou Guangdong China 510080
130 Local Institution Haikou Hainan China 570311
131 Local Institution Daqing Heilongjiang China 163001
132 Local Institution Zhengzhou Henan China 450052
133 Local Institution Nantong Jiangsu China 226001
134 Local Institution Yangzhou Jiangsu China 225001
135 Local Institution Changchun Jilin China 130021
136 Local Institution Shenyang Liaoning China 110016
137 Local Institution Qingdao Shandong China 266000
138 Local Institution YanTai Shandong China 264000
139 Local Institution Wenzhou Zhejiang China 325000
140 Local Institution Brno Czechia 656 91
141 Local Institution Ceske Budejovice Czechia 370 87
142 Local Institution Jihlava Czechia 586 33
143 Local Institution Olomouc Czechia 77520
144 Local Institution Ostrava Czechia 703 00
145 Local Institution Praha 2 Czechia 128 21
146 Local Institution Aalborg Denmark 9000
147 Local Institution Aarhus N Denmark 8200
148 Local Institution Copenhagen Denmark 2400
149 Local Institution Glostrup Denmark 2600
150 Local Institution Herlev Denmark 2730
151 Local Institution - 0111 Helsinki Etelä-Suomen Lääni Finland 00290
152 Local Institution Lappeenranta Finland 53130
153 Local Institution Turku Finland FI-20520
154 Local Institution Bordeaux France 33000
155 Local Institution Bourg-en-Bresse France 01012
156 Local Institution Brest France 29200
157 Local Institution Caen France 14033
158 Local Institution Créteil France 94010
159 Local Institution Lille France 59037
160 Local Institution Limoges Cedex France 87042
161 Local Institution Marseille France 13385
162 Local Institution Montpellier Cedex 5 France 34295
163 Local Institution Nancy France 54035
164 Local Institution Nimes France 30029
165 Local Institution Paris cedex 10 France 75475
166 Local Institution Paris France 75013
167 Local Institution Paris France 75018
168 Local Institution Paris France 75019
169 Local Institution Rouen Cedex France 76031
170 Local Institution Toulouse Cedex 9 France 31059
171 Local Institution Altenburg Germany 04600
172 Local Institution Berlin Germany 12203
173 Local Institution Berlin Germany 12351
174 Local Institution Bielefeld Germany 33617
175 Local Institution Bonn Germany 53127
176 Local Institution Bremen Germany 28755
177 Local Institution Dresden Germany 01307
178 Local Institution Erlangen Germany 91054
179 Local Institution Essen Germany 45131
180 Local Institution Frankfurt Am Maim Germany 65929
181 Local Institution Frankfurt am Main Germany 60528
182 Local Institution Gießen Germany 35392
183 Local Institution - 0056 Hamburg Germany 20246
184 Local Institution Hamburg Germany 22043
185 Local Institution Hamburg Germany 22763
186 Local Institution Hannover Germany D30625
187 Local Institution Heidelberg Germany 69120
188 Local Institution Leipzig Germany 04103
189 Local Institution Lübeck Germany 23538
190 Local Institution Magdeburg Germany 39120
191 Local Institution Minden Germany 32429
192 Local Institution Munster Germany 48149
193 Local Institution Osnabruck Germany 49076
194 Local Institution Regensburg Germany 93053
195 Local Institution Sande Germany 26452
196 Local Institution Siegen Germany 57076
197 Local Institution Sindelfingen Germany 71065
198 Local Institution Tubingen Germany 72076
199 Local Institution Ulm Germany 89081
200 Local Institution - 0438 Athina Attiki Greece 115 21
201 Local Institution Athens Greece 106 76
202 Local Institution Athens Greece 11525
203 Local Institution Athens Greece 11526
204 Local Institution - 0373 Athens Greece 11527
205 Local Institution Athens Greece 11527
206 Local Institution Athens Greece 11528
207 Local Institution Athens Greece 12461
208 Local Institution Crete Greece 71110
209 Local Institution - 0333 Ioannina Greece 45110
210 Local Institution - 0365 Ioannina Greece 45110
211 Local Institution Ioannina Greece 45445
212 Local Institution Larissa, Greece 41110
213 Local Institution Larissa Greece 41110
214 Local Institution Larissa Greece 41221
215 Local Institution Neo Faliro Greece 18547
216 Local Institution Patras Greece 26500
217 Local Institution Pireaus Greece 18536
218 Local Institution Thessaloniki Greece 54621
219 Local Institution Thessaloniki Greece 54636
220 Local Institution Thessaloniki Greece 54642
221 Local Institution Thessaloniki Greece 56403
222 Local Institution Thessaloniki Greece 57010
223 Local Institution Hong Kong Hong Kong
224 Local Institution Budapest Hungary 1083
225 Local Institution Budapest Hungary 1106
226 Local Institution Budapest Hungary 1134
227 Local Institution Budapest Hungary 1145
228 Local Institution Debrecen Hungary 4032
229 Local Institution Gyor Hungary 9024
230 Local Institution Kistarcsa Hungary 02143
231 Local Institution Kisvárda Hungary 4600
232 Local Institution Miskolc Hungary 3526
233 Local Institution Nyíregyháza Hungary 4400
234 Local Institution Pecs Hungary 7624
235 Local Institution - 0133 Szeged Hungary 6725
236 Local Institution Zalaegerszeg Hungary 8900
237 Local Institution Beer-Sheva Israel 85025
238 Local Institution Haifa Israel 31096
239 Local Institution Haifa Israel 34362
240 Local Institution Jerusalem Israel 91031
241 Local Institution Jerusalem Israel 91120
242 Local Institution Nahariya Israel 22100
243 Local Institution Petach Tikva Israel 4941492
244 Local Institution Ramat-Gan Israel 52621
245 Local Institution Tel Aviv Israel 64239
246 Local Institution - 0151 Ancona Marche Italy 60020
247 Local Institution Bologna Italy 40133
248 Local Institution Cagliari Italy 09134
249 Local Institution Genova Italy 16132
250 Local Institution Milano Italy 20132
251 Local Institution Modena Italy 1355-41126
252 Local Institution Negrar Italy 37024
253 Local Institution Pavia Italy 27100
254 Local Institution Perugia Italy 06012
255 Local Institution Perugia Italy 06129
256 Local Institution Roma Italy 00161
257 Local Institution Rome Italy 00152
258 Local Institution Verona Italy 37126
259 Local Institution Vibo Valentia Italy 89900
260 Local Institution Kasugai Aichi Japan 487-0016
261 Local Institution Nagoya-shi Aichi Japan 4600001
262 Local Institution Toyoake Shi Aichi Japan 4701192
263 Local Institution Toyohashi-shi Aichi Japan 440-8510
264 Local Institution Toyota-shi Aichi Japan 471-8513
265 Local Institution Sakura-shi Chiba Japan 285-8741
266 Local Institution Chikushino-shi Fukuoka Japan 818-8516
267 Local Institution Kasuga-shi Fukuoka Japan 816-0864
268 Local Institution Kitakyushu-shi Fukuoka Japan 802-8555
269 Local Institution Kitakyushu-shi Fukuoka Japan 8058508
270 Local Institution Kitakyushu Fukuoka Japan 800-0296
271 Local Institution Koga-shi Fukuoka Japan 811-3113
272 Local Institution Kurume City Fukuoka Japan 830-8577
273 Local Institution Aizuwakamatsu-shi Fukushima Japan 9658585
274 Local Institution Takayama-shi Gifu Japan 506-8550
275 Local Institution Isesaki-shi Gunma Japan 3720006
276 Local Institution Aki-gun Hiroshima Japan 735-8585
277 Local Institution Higashihiroshima-shi Hiroshima Japan 739-0041
278 Local Institution Hiroshima-shi Hiroshima Japan 731-0293
279 Local Institution Kobe-City Hyogo Japan 650-0047
280 Local Institution Kanazawa Ishikawa Japan 920-8650
281 Local Institution Komatsu Ishikawa Japan 923-8560
282 Local Institution Kagoshima-shi Kagoshima Japan 890-8760
283 Local Institution Kawasaki-city Kanagawa Japan 216-8511
284 Local Institution Kawasaki Kanagawa Japan 211-0063
285 Local Institution Sendai-shi Miyagi Japan 982-8523
286 Local Institution Sendai Miyagi Japan 9838520
287 Local Institution Nagasaki-shi Nagasaki Japan 8528501
288 Local Institution Izumisano-shi Osaka Japan 5988577
289 Local Institution Kishiwada Osaka Japan 596-8522
290 Local Institution Matsubara Osaka Japan 580-0032
291 Local Institution Sakai-shi Osaka Japan 590-0064
292 Local Institution Suita-shi Osaka Japan 5650871
293 Local Institution Suita Osaka Japan 5648565
294 Local Institution Hidaka Saitama Japan 858+6
295 Local Institution Shimotsuke-shi Tochigi Japan 3290498
296 Local Institution Bunkyo-ku Tokyo Japan 113-8603
297 Local Institution Hachioji Tokyo Japan 192-0032
298 Local Institution Meguro-ku Tokyo Japan 1528902
299 Local Institution Minato-ku Tokyo Japan 1058471
300 Local Institution Minato-ku Tokyo Japan 108-0073
301 Local Institution Mitaka-shi Tokyo Japan 181-8611
302 Local Institution - 0298 Shinagawa-ku Tokyo Japan 141-8625
303 Local Institution Shinjuku-Ku Tokyo Japan 1608582
304 Local Institution Tachikawa-shi Tokyo Japan 1900014
305 Local Institution Shimonoseki-Shi Yamaguchi Japan 752-8510
306 Local Institution Fukuoka Japan 810-0001
307 Local Institution Fukuoka Japan 810-8563
308 Local Institution Kyoto Japan 6008558
309 Local Institution Osaka Japan 533-0024
310 Local Institution Osaka Japan 540-0006
311 Local Institution Osaka Japan 558-8558
312 Local Institution Saga Japan 849-8501
313 Local Institution - 0094 Goyang-si Gyeonggido Korea, Republic of 10380
314 Local Institution Anyang Korea, Republic of 431-070
315 Local Institution Busan Korea, Republic of 49201
316 Local Institution Busan Korea, Republic of 49241
317 Local Institution Daegu Korea, Republic of 41944
318 Local Institution Daegu Korea, Republic of 42415
319 Local Institution Daegu Korea, Republic of 700-712
320 Local Institution Gwangju Korea, Republic of 61469
321 Local Institution Incheon Korea, Republic of 22332
322 Local Institution Seongnam-si Korea, Republic of 13620
323 Local Institution Seoul Korea, Republic of 01830
324 Local Institution Seoul Korea, Republic of 02447
325 Local Institution Seoul Korea, Republic of 03080
326 Local Institution Seoul Korea, Republic of 03722
327 Local Institution Seoul Korea, Republic of 04763
328 Local Institution Seoul Korea, Republic of 05505
329 Local Institution Seoul Korea, Republic of 06273
330 Local Institution Seoul Korea, Republic of 06351
331 Local Institution Seoul Korea, Republic of 07061
332 Local Institution Seoul Korea, Republic of 08308
333 Local Institution Ciudad de Mexico Distrito Federal Mexico 14080
334 Local Institution Mexico Distrito Federal Mexico 14269
335 Local Institution Guadalajara Jalisco Mexico 44670
336 Local Institution Monterrey Nuevo LEON Mexico 64460
337 Local Institution Culiacan Sinaloa Mexico 80020
338 Local Institution Durango Mexico 34217
339 Local Institution Bergen Norway 5021
340 Local Institution Grålum Norway 1714
341 Local Institution Kristiansand Norway 4604
342 Local Institution Lørenskog Norway 1478
343 Local Institution Oslo Norway 0424
344 Local Institution Stavanger Norway 4011
345 Local Institution Bydgoszcz Poland 85-094
346 Local Institution Chelm Poland 22-100
347 Local Institution Gdansk Poland 80-803
348 Local Institution Grodzisk Mazowieciki Poland 05-825
349 Local Institution Katowice Poland 40-635
350 Local Institution Konskie Poland 26-200
351 Local Institution Lodz Poland 93-113
352 Local Institution Olsztyn Poland 10-561
353 Local Institution Sandomierz Poland 27-600
354 Local Institution Skarzysko-Kamienna Poland 26-110
355 Local Institution Walcz Poland 78-600
356 Local Institution Warszawa Poland 02-097
357 Local Institution Warszawa Poland 02-957
358 Local Institution Warszawa Poland 04-141
359 Local Institution Wejherowo Poland 84-200
360 Local Institution Barnaul Russian Federation 656024
361 Local Institution Kemerovo Russian Federation 650002
362 Local Institution Moscow Russian Federation 117593
363 Local Institution Moscow Russian Federation 125367
364 Local Institution Novosibirsk Russian Federation 630087
365 Local Institution Smolensk Russian Federation 214018
366 Local Institution St. Petersburg Russian Federation 194354
367 Local Institution Yaroslavl Russian Federation 150030
368 Local Institution - 0372 León Castilla Y León Spain 24071
369 Local Institution A Coruna Spain 15006
370 Local Institution Albacete Spain 02006
371 Local Institution Badalona Spain 8916
372 Local Institution Barcelona Spain 08003
373 Local Institution Barcelona Spain 08035
374 Local Institution Barcelona Spain 08036
375 Local Institution Córdoba Spain 14004
376 Local Institution Girona Spain 17007
377 Local Institution L'Hospitalet de Llobregat Spain 08907
378 Local Institution Lleida Spain 25008
379 Local Institution Madrid Spain 28007
380 Local Institution Madrid Spain 28034
381 Local Institution Madrid Spain 28041
382 Local Institution Madrid Spain 28046
383 Local Institution Sabadell, Barcelona Spain 08208
384 Local Institution San Sebastian Spain 20014
385 Local Institution Sant Joan Despi Spain 08970
386 Local Institution Santiago de Compostela Spain 15706
387 Local Institution Sevilla Spain 41009
388 Local Institution Sevilla Spain 41013
389 Local Institution Tarragona Spain 43005
390 Local Institution Terrassa Spain 08222
391 Local Institution Valencia Spain 46026
392 Local Institution Valladolid Spain 47005
393 Local Institution Vigo Spain 36312
394 Local Institution - 0128 Malmö Skane Lan Sweden SE-205 02
395 Local Institution Göteborg Sweden SE-43146
396 Local Institution Hassleholm Sweden 28125
397 Local Institution Umea Sweden 901 87
398 Local Institution Uppsala Sweden 751 85
399 Local Institution Aarau Switzerland 5001
400 Local Institution Basel Switzerland 4031
401 Local Institution Bern Switzerland 3010
402 Local Institution Geneve Switzerland 1205
403 Local Institution Lausanne Switzerland 1011
404 Local Institution Zurich Switzerland 8032
405 Local Institution Canterbury Kent United Kingdom CT1 3NG
406 Local Institution Aberdeen United Kingdom AB25 2ZD
407 Local Institution Ashford United Kingdom TN24 0LZ
408 Local Institution Bath United Kingdom BA1 3NG
409 Local Institution Chester United Kingdom CH2 1UL
410 Local Institution Edinburgh United Kingdom EH16 4SA
411 Local Institution Glasgow United Kingdom G51 4TF
412 Local Institution Lancashire United Kingdom BL9 7TD
413 Local Institution London United Kingdom SE5 9RF
414 Local Institution London United Kingdom W1T 7HA
415 Local Institution Luton United Kingdom LU4 0DZ
416 Local Institution Manchester United Kingdom M6 8HD
417 Local Institution Nottingham United Kingdom NG5 1PB
418 Local Institution Sheffield United Kingdom S10 2JF
419 Local Institution Staffordshire United Kingdom ST4 6QG

Sponsors and Collaborators

  • Bristol-Myers Squibb
  • Janssen, LP

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT03766581
Other Study ID Numbers:
  • CV010-031
First Posted:
Dec 6, 2018
Last Update Posted:
Apr 5, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 5, 2022