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Trial record 79 of 412 for:    ASPIRIN AND clopidogrel AND Purinergic Antagonists

Oral Factor XIa Inhibitor for the Prevention of New Ischemic Stroke in Patients Receiving Aspirin and Clopidogrel Following Acute Ischemic Stroke or Transient Ischemic Attack (TIA) (AXIOMATIC-SSP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03766581
Recruitment Status : Recruiting
First Posted : December 6, 2018
Last Update Posted : October 1, 2019
Sponsor:
Collaborator:
Janssen, LP
Information provided by (Responsible Party):
Bristol-Myers Squibb

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. The safety of this treatment will also be studied.

Condition or disease Intervention/treatment Phase
Acute Ischemic Stroke Transient Ischemic Attack (TIA) Drug: BMS-986177 Other: BMS-986177 Placebo Drug: Clopidogrel Drug: Aspirin Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 3000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Dose ranging study using RAR (Response Adaptive Randomization) design
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Global, Phase 2, Randomized, Double-Blind, Placebo-Controlled, Response-Adaptive 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 : November 30, 2018
Estimated Primary Completion Date : May 31, 2021
Estimated Study Completion Date : August 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: BMS-986177 Placebo
100 mg Aspirin + 75 mg Clopidogrel
Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 A
25 mg BMS-986177 QD (daily) + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 B
25 mg BMS-986177 BID (twice daily) + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 C
50 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 D
50 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 E
100 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 F
100 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 G
200 mg BMS-986177 QD + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration

Experimental: BMS-986177 H
200 mg BMS-986177 BID + 100 mg Aspirin + 75 mg Clopidogrel
Drug: BMS-986177
Oral administration

Other: BMS-986177 Placebo
Oral Administration

Drug: Clopidogrel
Oral administration

Drug: Aspirin
Oral administration




Primary Outcome Measures :
  1. Composite of new ischemic stroke and new covert brain infarction (FLAIR+DWI) during the treatment period [ Time Frame: 90 days ]

Secondary Outcome Measures :
  1. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: 90 days ]
  2. Event rate based on BARC, ISTH and PLATO-defined criteria [ Time Frame: 90 days ]
  3. Rate of the composite of new ischemic stroke and new covert brain infarction (FLAIR + DWI) during the treatment period detected by MRI at 90 days [ Time Frame: 90 days ]
  4. Percent change from baseline in aPTT and Factor XI clotting activity during treatment [ Time Frame: 90 days ]
  5. Percent change from baseline in Factor XI [ Time Frame: 90 days ]
  6. Location of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  7. Number of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  8. Volume of new FLAIR + DWI lesions [ Time Frame: 90 days ]
    Detected by MRI

  9. National Institute of Health Stroke Scale (NIHSS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177

  10. Modified Rankin Scale (mRS) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177

  11. Montreal Cognitive Assessment (MoCA) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177

  12. Digit Symbol Substitution Test (DSST) on Days 21 and 90 and at the time of a new stroke event [ Time Frame: 21 and 90 days ]
    BMS-986177

  13. Estimated clearance (CL) [ Time Frame: 90 days ]
    CL will be described using descriptive statistics

  14. Volume of distribution (Vd) [ Time Frame: 90 days ]
    Vd will be described using descriptive statistics

  15. Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction during the treatment period [ Time Frame: 90 days ]
  16. Event rates for all cause-death during the treatment period [ Time Frame: 90 days ]
  17. Incidence of AE's and SAE's [ Time Frame: 90 days ]
    BMS-986177

  18. Distribution of clinical characteristics [ Time Frame: 90 days ]
    BMS-986177 clinical characteristics will be summarized using descriptive statistics



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com

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 acute ischemic stroke event

Other protocol defined inclusion/exclusion criteria could apply


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03766581


Contacts
Layout table for location contacts
Contact: Recruiting sites have contact information. Please contact the sites directly. If there is no contact information please email Clinical.Trials@bms.com
Contact: First line of the email MUST contain NCT # and Site #

  Hide Study Locations
Locations
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United States, Alabama
Local Institution Not yet recruiting
Birmingham, Alabama, United States, 35233
Contact: Site 0029         
United States, California
Glendale Adventist Medical Center Recruiting
Glendale, California, United States, 91206
Contact: Lance Lee, Site 0007    818-409-8009      
Long Beach Memorial Medical Center Recruiting
Long Beach, California, United States, 90806
Contact: Nirav Patel, Site 0006    562-933-1239      
Local Institution Not yet recruiting
Los Angeles, California, United States, 90024
Contact: Site 0231         
Kaiser Permanente Los Angeles Medical Center Recruiting
Los Angeles, California, United States, 90027
Contact: Navdeep Sangha, Site 0002    323-371-3807      
Stanford Stroke Center Recruiting
Stanford, California, United States, 94305
Contact: Nirali Vora, Site 0004    650-725-0232      
Harbor UCLA Medical Center Recruiting
Torrance, California, United States, 90502
Contact: Bijal Mehta, Site 0042         
United States, Florida
Local Institution Not yet recruiting
Gainesville, Florida, United States, 32610
Contact: Site 0075         
Local Institution Not yet recruiting
Sarasota, Florida, United States, 34239
Contact: Site 0013         
Local Institution Not yet recruiting
Tampa, Florida, United States, 33606
Contact: Site 0024         
United States, Georgia
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Contact: Dan-Victor Giurgiutiu, Site 0015         
United States, Louisiana
Ochsner Clinic Foundation Recruiting
New Orleans, Louisiana, United States, 70121
Contact: Richard Zweifler, Site 0047         
United States, Massachusetts
Local Institution Not yet recruiting
Boston, Massachusetts, United States, 02215
Contact: Site 0236         
Local Institution Not yet recruiting
Worcester, Massachusetts, United States, 01655
Contact: Site 0046         
United States, Minnesota
Local Institution Not yet recruiting
Rochester, Minnesota, United States, 55905-0001
Contact: Site 0030         
United States, Missouri
Local Institution Not yet recruiting
Kansas City, Missouri, United States, 64111
Contact: Site 0058         
United States, Montana
Advanced Neurology Specialists PLLC Recruiting
Great Falls, Montana, United States, 59405
Contact: Dennis Dietrich, Site 0001    406-455-2583      
United States, New Jersey
Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Contact: Deviyani Mehta, Site 0039         
United States, New York
Local Institution Not yet recruiting
New York, New York, United States, 10032
Contact: Site 0125         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: David Huang, Site 0043         
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Matthew Ehrlich, Site 0021    919-684-8969      
Guilford Neurologic Associates Recruiting
Greensboro, North Carolina, United States, 27401
Contact: Pramodkumar Sethi, Site 0016    336-516-9104      
Local Institution Not yet recruiting
High Point, North Carolina, United States, 27262
Contact: Site 0195         
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106-5055
Contact: Cathy Sila, Site 0003         
Cleveland Clinic Recruiting
Wooster, Ohio, United States, 44691
Contact: Muhammad Shazam Hussain, Site 0050         
United States, Oklahoma
Local Institution Not yet recruiting
Oklahoma City, Oklahoma, United States, 73112
Contact: Site 0218         
United States, Oregon
Local Institution Not yet recruiting
Portland, Oregon, United States, 97225
Contact: Site 0074         
Oregon Health and Science University Recruiting
Portland, Oregon, United States, 97239
Contact: Hormozd Bozorgchami, Site 0022         
United States, Pennsylvania
Local Institution Not yet recruiting
Allentown, Pennsylvania, United States, 18103-6381
Contact: Site 0194         
UPMC Hamot Recruiting
Erie, Pennsylvania, United States, 16550-0001
Contact: Trevor Phinney, Site 0018    814-877-6000      
Hospital of The University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Brett Cucchiara, Site 0020         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Nina Gentile, Site 0038         
WellSpan York Hospital Recruiting
York, Pennsylvania, United States, 17403
Contact: Brent Becker, Site 0019    717-851-4104      
United States, South Carolina
Prisma Health?Midlands Recruiting
Columbia, South Carolina, United States, 29203
Contact: Souvik Sen, Site 0041         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Howard Kirshner, Site 0009    615-936-1354      
United States, Texas
Dell Seton Medical School at The University of Texas - Stroke Institute Recruiting
Austin, Texas, United States, 78712
Contact: Truman Milling, Site 0008         
Local Institution Not yet recruiting
Austin, Texas, United States, 78712
Contact: Site 0082         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75321
Contact: Site 0037         
Local Institution Not yet recruiting
Dallas, Texas, United States, 75390-88520
Contact: Site 0060         
University Medical center of El Paso Recruiting
El Paso, Texas, United States, 79905
Contact: Alberto Maud, Site 0017         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030-5206
Contact: Site 0040         
Local Institution Not yet recruiting
Houston, Texas, United States, 77030
Contact: Site 0093         
Local Institution Not yet recruiting
Temple, Texas, United States, 76508
Contact: Site 0187         
Argentina
Local Institution Not yet recruiting
Adrogue, Buenos Aires, Argentina, B1846DSK
Contact: Site 0100         
Local Institution Not yet recruiting
Capital Federal, Buenos Aires, Argentina, 1188
Contact: Site 0067         
Local Institution Not yet recruiting
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, 1425
Contact: Site 0069         
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Lomas de Zamora, Buenos Aires, Argentina, 1832
Contact: Site 0237         
Local Institution Not yet recruiting
Buenos Aires, Argentina, 1437
Contact: Site 0099         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1181ACH
Contact: Site 0063         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1425DND
Contact: Site 0068         
Local Institution Not yet recruiting
Buenos Aires, Argentina, C1428AQK
Contact: Site 0076         
Local Institution Not yet recruiting
Santa Fe, Argentina, 3000
Contact: Site 0235         
Austria
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Feldbach, Austria, 8330
Contact: Site 0148         
Local Institution Not yet recruiting
Klagenfurt Am Woerthersee, Austria, 9020
Contact: Site 0184         
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St. Polten, Austria, 3100
Contact: Site 0188         
Local Institution Not yet recruiting
Vocklabruck, Austria, 4840
Contact: Site 0106         
Belgium
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Brasschaat, Belgium, 2930
Contact: Site 0207         
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Brussel, Belgium, 1090
Contact: Site 0196         
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Bruxelles, Belgium, 1200
Contact: Site 0190         
Local Institution Not yet recruiting
Edegem, Belgium, 2650
Contact: Site 0122         
Local Institution Not yet recruiting
Gent, Belgium, 9000
Contact: Site 0199         
Local Institution Not yet recruiting
Kortrijk, Belgium, 8500
Contact: Site 0103         
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Leuven, Belgium, 3000
Contact: Site 0098         
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Montegnee, Belgium, 4420
Contact: Site 0178         
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Yvoir, Belgium, 5530
Contact: Site 0192         
Brazil
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Fortaleza, Ceara, Brazil, 60175-295
Contact: Site 0072         
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Joinville, Santa Catarina, Brazil, 89202 165
Contact: Site 0219         
Local Institution Not yet recruiting
Botucatu, SAO Paulo, Brazil, 18618-970
Contact: Site 0245         
Local Institution Not yet recruiting
Campinas, SAO Paulo, Brazil, 13083-970
Contact: Site 0065         
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Porto Alegre, SAO Paulo, Brazil, 90035-903
Contact: Site 0200         
Local Institution Not yet recruiting
S?o Paulo, SAO Paulo, Brazil, 01221-020
Contact: Site 0234         
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S?o Paulo, SAO Paulo, Brazil, 04024-002
Contact: Site 0248         
Local Institution Not yet recruiting
S?o Paulo, SAO Paulo, Brazil, 09030-010
Contact: Site 0113         
Canada, Alberta
Local Institution Recruiting
Calgary, Alberta, Canada, T2N 4Z6
Contact: Site 0057         
Local Institution Recruiting
Edmonton, Alberta, Canada, T6G 2R3
Contact: Site 0061         
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Lethbridge, Alberta, Canada, T1J 0N9
Contact: Site 0059         
Canada, British Columbia
Local Institution Not yet recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Site 0121         
Canada, Ontario
Local Institution Recruiting
Hamilton, Ontario, Canada, L8L 2X2
Contact: Site 0054         
Local Institution Not yet recruiting
London, Ontario, Canada, N6A 4G5
Contact: Site 0227         
Local Institution Not yet recruiting
Toronto,, Ontario, Canada, M4N 3M5
Contact: Site 0124         
Local Institution Not yet recruiting
Toronto, Ontario, Canada, M5B 1W8
Contact: Site 0146         
Canada, Quebec
Local Institution Not yet recruiting
Greenfield Park, Quebec, Canada, J4V 2HI
Contact: Site 0155         
Local Institution Not yet recruiting
Montreal, Quebec, Canada, H2L 4M1
Contact: Site 0066         
Canada
Local Institution Recruiting
Quebec, Canada, G1J 1Z4
Contact: Site 0064         
Chile
Local Institution Not yet recruiting
Los Angeles, Biobio, Chile
Contact: Site 0062         
Local Institution Not yet recruiting
Valdiva, Los Rios, Chile, 5090145
Contact: Site 0131         
Local Institution Not yet recruiting
Vi?a Del Mar, Valparaiso, Chile
Contact: Site 0172         
Local Institution Not yet recruiting
Vi?a Del Mar, Valparaiso, Chile
Contact: Site 0167         
Czechia
Local Institution Not yet recruiting
Brno, Czechia, 656 91
Contact: Site 0005         
Local Institution Not yet recruiting
Ceske Budejovice, Czechia, 370 87
Contact: Site 0031         
Local Institution Not yet recruiting
Ostrava - Vitkovice, Czechia, 703 84
Contact: Site 0023         
Denmark
Local Institution Not yet recruiting
?lborg, Denmark, 9000
Contact: Site 0217         
Local Institution Not yet recruiting
Aarhus C, Denmark, 8000
Contact: Site 0127         
Local Institution Not yet recruiting
Glostrup, Denmark, 2600
Contact: Site 0110         
Local Institution Not yet recruiting
Herlev, Denmark, 2730
Contact: Site 0117         
Local Institution Not yet recruiting
K?benhavn NV, Denmark, DK-2400
Contact: Site 0142         
Finland
Local Institution Not yet recruiting
Helsinki, Finland, 00290
Contact: Site 0111         
Local Institution Not yet recruiting
Turku, Finland, FI-20521
Contact: Site 0143         
France
Local Institution Recruiting
Bordeaux, France, 33076
Contact: Site 0051         
Local Institution Not yet recruiting
Brest, France, 29200
Contact: Site 0165         
Local Institution Not yet recruiting
Caen, France, 14033
Contact: Site 0174         
Local Institution Not yet recruiting
Creteil, France, 94010
Contact: Site 0189         
Local Institution Recruiting
Lille, France, 59037
Contact: Site 0048         
Local Institution Not yet recruiting
Limoges, France, 87042
Contact: Site 0182         
Local Institution Not yet recruiting
Marseille, France, 13385
Contact: Site 0168         
Local Institution Not yet recruiting
Nimes, France, 30029
Contact: Site 0205         
Local Institution Not yet recruiting
Paris Cedex 13, France, 75651
Contact: Site 0169         
Local Institution Recruiting
Paris, France, 75018
Contact: Site 0028         
Local Institution Not yet recruiting
Paris, France, 75019
Contact: Site 0126         
Local Institution Recruiting
Paris, France, 75475
Contact: Site 0049         
Local Institution Not yet recruiting
Rouen, France, 76031
Contact: Site 0107         
Germany
Local Institution Not yet recruiting
Altenburg, Germany, 04600
Contact: Site 0011         
Local Institution Not yet recruiting
Berlin, Germany, 12203
Contact: Site 0032         
Local Institution Not yet recruiting
Berlin, Germany, 12351
Contact: Site 0035         
Local Institution Not yet recruiting
Bielefeld, Germany, 33617
Contact: Site 0073         
Local Institution Not yet recruiting
Bonn, Germany, 53105
Contact: Site 0250         
Local Institution Not yet recruiting
Dresden, Germany, 01277
Contact: Site 0144         
Local Institution Not yet recruiting
Erlangen, Germany, 91054
Contact: Site 0097         
Local Institution Not yet recruiting
Essen, Germany, 45131
Contact: Site 0053         
Local Institution Not yet recruiting
Gie?en, Germany, 35392
Contact: Site 0254         
Local Institution Not yet recruiting
Hamburg, Germany, 22043
Contact: Site 0044         
Local Institution Not yet recruiting
Hamburg, Germany, 22763
Contact: Site 0034         
Local Institution Not yet recruiting
Heidelberg, Germany, 69120
Contact: Site 0055         
Local Institution Not yet recruiting
Leipzig, Germany, ?04103
Contact: Site 0090         
Local Institution Not yet recruiting
Lübeck, Germany, 23538
Contact: Site 0258         
Local Institution Not yet recruiting
Minden, Germany, 32429
Contact: Site 0036         
Local Institution Not yet recruiting
Munster, Germany, 48149
Contact: Site 0256         
Local Institution Not yet recruiting
Siegen, Germany, 57076
Contact: Site 0033         
Local Institution Not yet recruiting
Tubingen, Germany, 72076
Contact: Site 0045         
Local Institution Not yet recruiting
Ulm, Germany, 89081
Contact: Site 0241         
Greece
Local Institution Not yet recruiting
Larissa, Greece, 41110
Contact: Site 0161         
Local Institution Not yet recruiting
Pireas, Greece, 18536
Contact: Site 0208         
Local Institution Not yet recruiting
Thessaloniki, Greece, 56429
Contact: Site 0210         
Hungary
Local Institution Not yet recruiting
Budapest, Hungary, 1083
Contact: Site 0134         
Local Institution Not yet recruiting
Budapest, Hungary, 1106
Contact: Site 0077         
Local Institution Not yet recruiting
Budapest, Hungary, 1134
Contact: Site 0119         
Local Institution Not yet recruiting
Budapest, Hungary, 1145
Contact: Site 0136         
Local Institution Not yet recruiting
Debrecen, Hungary, 4032
Contact: Site 0154         
Local Institution Not yet recruiting
Gyor, Hungary, 9024
Contact: Site 0079         
Local Institution Not yet recruiting
Kistarcsa, Hungary, 02143
Contact: Site 0175         
Local Institution Not yet recruiting
Miskolc, Hungary, 3526
Contact: Site 0070         
Local Institution Not yet recruiting
Nyiregyhaza, Hungary, 4400
Contact: Site 0220         
Local Institution Not yet recruiting
Pecs, Hungary, 7624
Contact: Site 0138         
Local Institution Not yet recruiting
Szeged, Hungary, 6720
Contact: Site 0133         
Local Institution Not yet recruiting
Zalaegerszeg, Hungary, 8900
Contact: Site 0137         
Israel
Local Institution Not yet recruiting
Haifa, Israel, 31096
Contact: Site 0139         
Local Institution Not yet recruiting
Jerusalem, Israel, 91031
Contact: Site 0092         
Local Institution Not yet recruiting
Jerusalem, Israel, 91031
Contact: Site 0193         
Local Institution Not yet recruiting
Jerusalem, Israel, 91240
Contact: Site 0078         
Local Institution Not yet recruiting
Petah Tikva, Israel, 49100
Contact: Site 0247         
Local Institution Not yet recruiting
Ramat-Gan, Israel, 52621
Contact: Site 0204         
Local Institution Not yet recruiting
Tel Aviv, Israel, 64239
Contact: Site 0086         
Italy
Local Institution Not yet recruiting
Ancona, Italy, 60020
Contact: Site 0151         
Local Institution Not yet recruiting
Baggiovara, Italy, 41126
Contact: Site 0104         
Local Institution Not yet recruiting
Bologna, Italy, 40139
Contact: Site 0156         
Local Institution Not yet recruiting
Citta di Castello, Italy, 06012
Contact: Site 0085         
Local Institution Not yet recruiting
Milano, Italy, 20132
Contact: Site 0095         
Local Institution Not yet recruiting
Negrar, Italy, 37024
Contact: Site 0149         
Local Institution Not yet recruiting
Pavia, Italy, 27100
Contact: Site 0084         
Local Institution Not yet recruiting
Perugia, Italy, 06126
Contact: Site 0114         
Local Institution Not yet recruiting
Roma, Italy, 00149
Contact: Site 0108         
Local Institution Not yet recruiting
Rome, Italy, 00161
Contact: Site 0129         
Local Institution Not yet recruiting
Verona, Italy, 37134
Contact: Site 0083         
Local Institution Not yet recruiting
Vibo Valentia, Italy, 89900
Contact: Site 0123         
Japan
Local Institution Not yet recruiting
Kasuga-shi, Fukuoka, Japan, 816-0864
Contact: Site 0259         
Local Institution Not yet recruiting
Kitakyushu-shi, Fukuoka, Japan, 802-8555
Contact: Site 0229         
Local Institution Not yet recruiting
Koga-shi, Fukuoka, Japan, 811-3195
Contact: Site 0230         
Local Institution Not yet recruiting
Aizuwakamatsu, Fukushima, Japan, 965-8585
Contact: Site 0257         
Local Institution Not yet recruiting
Isesaki-shi, Gunma, Japan, 3720006
Contact: Site 0211         
Local Institution Not yet recruiting
Higashihiroshima-shi, Hiroshima, Japan, 739-0041
Contact: Site 0240         
Local Institution Not yet recruiting
Kobe City, Hyogo, Japan, 6500047
Contact: Site 0226         
Local Institution Not yet recruiting
Kawasaki-city, Kanagawa, Japan, 216-8511
Contact: Site 0228         
Local Institution Not yet recruiting
Nagasaki-shi, Nagasaki, Japan, 8528102
Contact: Site 0261         
Local Institution Not yet recruiting
Niigata-shi, Niigata, Japan, 950-1197
Contact: Site 0246         
Local Institution Not yet recruiting
Suita-shi, Osaka, Japan, 5650871
Contact: Site 0244         
Local Institution Not yet recruiting
Suita, Osaka, Japan, 5658565
Contact: Site 0251         
Local Institution Not yet recruiting
Bunkyo-ku, Tokyo, Japan, 1138603
Contact: Site 0232         
Local Institution Not yet recruiting
Meguro-ku, Tokyo, Japan, 1528902
Contact: Site 0255         
Local Institution Not yet recruiting
Fukuoka, Japan, 810-8563
Contact: Site 0243         
Local Institution Not yet recruiting
Osaka, Japan, 540-0006
Contact: Site 0239         
Korea, Republic of
Local Institution Not yet recruiting
Anyang, Korea, Republic of, 431-070
Contact: Site 0081         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 49241
Contact: Site 0166         
Local Institution Not yet recruiting
Busan, Korea, Republic of, 602-715
Contact: Site 0109         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 700-712
Contact: Site 0135         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 700-721
Contact: Site 0179         
Local Institution Not yet recruiting
Daegu, Korea, Republic of, 705-703
Contact: Site 0102         
Local Institution Not yet recruiting
Goyang-si, Korea, Republic of, 10380
Contact: Site 0094         
Local Institution Not yet recruiting
Gwangju, Korea, Republic of, 61469
Contact: Site 0105         
Local Institution Not yet recruiting
Gyeonggi-do, Korea, Republic of, 463-707
Contact: Site 0153         
Local Institution Not yet recruiting
Incheon, Korea, Republic of, 22332
Contact: Site 0101         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 02447
Contact: Site 0185         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 03080
Contact: Site 0071         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 04763
Contact: Site 0120         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 06273
Contact: Site 0145         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 06351
Contact: Site 0091         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 07061
Contact: Site 0152         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 120-752
Contact: Site 0080         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 138736
Contact: Site 0088         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 139872
Contact: Site 0087         
Local Institution Not yet recruiting
Seoul, Korea, Republic of, 152-703
Contact: Site 0112         
Norway
Local Institution Not yet recruiting
Kristiansand, Norway, 4604
Contact: Site 0160         
Local Institution Not yet recruiting
L?renskog, Norway, N-1478
Contact: Site 0130         
Poland
Local Institution Not yet recruiting
Chelm, Poland, 22-100
Contact: Site 0216         
Local Institution Not yet recruiting
Gdansk, Poland, 80-803
Contact: Site 0206         
Local Institution Not yet recruiting
Grodzisk Mazowiecki, Poland, 05-825
Contact: Site 0181         
Local Institution Not yet recruiting
Katowice, Poland, 40-635
Contact: Site 0253         
Local Institution Not yet recruiting
Konskie, Poland, 26-200
Contact: Site 0180         
Local Institution Not yet recruiting
Lodz, Poland, 93-113
Contact: Site 0197         
Local Institution Not yet recruiting
Olsztyn, Poland, 10-561
Contact: Site 0198         
Local Institution Not yet recruiting
Sandomierz, Poland, 27-600
Contact: Site 0215         
Local Institution Not yet recruiting
Skarzysko Kamienna, Poland, 26-110
Contact: Site 0183         
Local Institution Not yet recruiting
Walcz, Poland, 78-600
Contact: Site 0225         
Local Institution Not yet recruiting
Warszawa, Poland, 02-097
Contact: Site 0213         
Local Institution Not yet recruiting
Warszawa, Poland, 02-957
Contact: Site 0214         
Local Institution Not yet recruiting
Wejherowo, Poland, 84-200
Contact: Site 0212         
Russian Federation
Local Institution Not yet recruiting
Kemerovo, Russian Federation, 650002
Contact: Site 0260         
Local Institution Not yet recruiting
Moscow, Russian Federation, 125367
Contact: Site 0116         
Local Institution Not yet recruiting
Smolensk, Russian Federation, 214018
Contact: Site 0202         
Local Institution Not yet recruiting
Vladimir, Russian Federation, 600020
Contact: Site 0170         
Local Institution Not yet recruiting
Yaroslavl, Russian Federation, 150030
Contact: Site 0233         
Spain
Local Institution Recruiting
A Coruna, Spain, 15006
Contact: Site 0141         
Local Institution Recruiting
Albacete, Spain, 02006
Contact: Site 0026         
Local Institution Recruiting
Badalona, Spain, 08916
Contact: Site 0052         
Local Institution Recruiting
Barcelona, Spain, 08003
Contact: Site 0012         
Local Institution Recruiting
Barcelona, Spain, 08035
Contact: Site 0010         
Local Institution Recruiting
Barcelona, Spain, 08036
Contact: Site 0027         
Local Institution Not yet recruiting
L'Hospitalet de Llobregat, Spain, 08907
Contact: Site 0176         
Local Institution Not yet recruiting
Lleida, Spain, 25198
Contact: Site 0249         
Local Institution Not yet recruiting
Madrid, Spain, 28007
Contact: Site 0238         
Local Institution Recruiting
Madrid, Spain, 28034
Contact: Site 0025         
Local Institution Not yet recruiting
Sabadell (Barcelona), Spain, 08208
Contact: Site 0159         
Local Institution Not yet recruiting
Sant Joan Despi, Spain, 08970
Contact: Site 0163         
Local Institution Not yet recruiting
Sevilla, Spain, 41009
Contact: Site 0158         
Local Institution Not yet recruiting
Sevilla, Spain, 41013
Contact: Site 0177         
Local Institution Not yet recruiting
Tarragona, Spain, 43005
Contact: Site 0164         
Local Institution Not yet recruiting
Terrassa, Spain, 08221
Contact: Site 0150         
Local Institution Recruiting
Valencia, Spain, 46026
Contact: Site 0147         
Local Institution Recruiting
Valladolid, Spain, 47005
Contact: Site 0014         
Sweden
Local Institution Not yet recruiting
Goteborg, Sweden, 41345
Contact: Site 0171         
Local Institution Not yet recruiting
Hassleholm, Sweden, SE-28125
Contact: Site 0191         
Local Institution Not yet recruiting
Malmo, Sweden, SE-20502
Contact: Site 0128         
Local Institution Not yet recruiting
Ume?, Sweden, 901 87
Contact: Site 0224         
Local Institution Not yet recruiting
Uppsala, Sweden, 755 92
Contact: Site 0132         
Switzerland
Local Institution Not yet recruiting
Aarau, Switzerland, 5001
Contact: Site 0162         
Local Institution Not yet recruiting
Basel, Switzerland, 4031
Contact: Site 0118         
Local Institution Not yet recruiting
Bern, Switzerland, 3010
Contact: Site 0115         
Local Institution Not yet recruiting
Geneva, Switzerland, 1205
Contact: Site 0203         
Local Institution Not yet recruiting
Lausanne, Switzerland, 1011
Contact: Site 0201         
Local Institution Not yet recruiting
Zurich, Switzerland, 8032
Contact: Site 0252         
United Kingdom
Local Institution Not yet recruiting
Bournemouth, Hampshire, United Kingdom, BH7 7DW
Contact: Site 0173         
Local Institution Not yet recruiting
Bath, Somerset, United Kingdom, BA1 3NG
Contact: Site 0157         
Local Institution Not yet recruiting
Birmingham, WEST Midlands, United Kingdom, B15 2GW
Contact: Site 0223         
Local Institution Not yet recruiting
Aberdeen, United Kingdom, AB25 2ZN
Contact: Site 0140         
Local Institution Not yet recruiting
Chester, United Kingdom, CH2 1UL
Contact: Site 0089         
Local Institution Not yet recruiting
Edinburgh, United Kingdom, EH16 4SA
Contact: Site 0221         
Local Institution Not yet recruiting
Glasgow, United Kingdom, G51 4TF
Contact: Site 0096         
Local Institution Not yet recruiting
London, United Kingdom, SE5 9RF
Contact: Site 0186         
Local Institution Not yet recruiting
London, United Kingdom, WC1N 3BG
Contact: Site 0242         
Local Institution Not yet recruiting
Margate, United Kingdom, CT9 4AN
Contact: Site 0222         
Local Institution Not yet recruiting
Redditch, United Kingdom, B987UB
Contact: Site 0209         
Sponsors and Collaborators
Bristol-Myers Squibb
Janssen, LP
Investigators
Layout table for investigator information
Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

Additional Information:
Layout table for additonal information
Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT03766581     History of Changes
Other Study ID Numbers: CV010-031
First Posted: December 6, 2018    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Aspirin
Clopidogrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Stroke
Cerebral Infarction
Ischemic Attack, Transient
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action