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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03766581




Registration number
NCT03766581
Ethics application status
Date submitted
13/11/2018
Date registered
6/12/2018
Date last updated
7/07/2020

Titles & IDs
Public title
A Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
Scientific 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)
Secondary ID [1] 0 0
CV010-031
Universal Trial Number (UTN)
Trial acronym
AXIOMATIC-SSP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Acute Ischemic Stroke 0 0
Transient Ischemic Attack (TIA) 0 0
Condition category
Condition code
Stroke 0 0 0 0
Haemorrhagic
Stroke 0 0 0 0
Ischaemic
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BMS-986177
Other interventions - Placebo
Treatment: Drugs - Clopidogrel
Treatment: Drugs - Aspirin

Placebo Comparator: BMS-986177 Placebo - Specified Dose on Specified Days

Experimental: Dose 1: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 2: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 3: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 4: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 5: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 6: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days

Experimental: Dose 7: BMS-986177 + Aspirin + Clopidogrel - Specified Dose on Specified Days


Treatment: Drugs: BMS-986177
Oral administration

Other interventions: Placebo
Oral Administration

Treatment: Drugs: Clopidogrel
Oral administration

Treatment: Drugs: Aspirin
Oral administration

Intervention code [1] 0 0
Treatment: Drugs
Intervention code [2] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Composite of new ischemic stroke during the treatment period and new covert brain infarction (FLAIR + DWI) detected by MRI
Timepoint [1] 0 0
Up to 90 days
Secondary outcome [1] 0 0
Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5
Timepoint [1] 0 0
Up to 90 days
Secondary outcome [2] 0 0
Event rate based on BARC, International Society on Thrombosis and Hemostasis (ISTH) and Platelet Inhibition and Patient Outcomes (PLATO)-defined criteria
Timepoint [2] 0 0
Up to 90 days
Secondary outcome [3] 0 0
Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period
Timepoint [3] 0 0
Up to 90 days
Secondary outcome [4] 0 0
Location of new FLAIR + DWI lesions
Timepoint [4] 0 0
Up to 90 days
Secondary outcome [5] 0 0
Number of new FLAIR + DWI lesions
Timepoint [5] 0 0
Up to 90 days
Secondary outcome [6] 0 0
Volume of new FLAIR + DWI lesions
Timepoint [6] 0 0
Up to 90 days
Secondary outcome [7] 0 0
Event rates for new ischemic, non-fatal stroke, non-fatal myocardial infarction and all-cause death during the treatment period
Timepoint [7] 0 0
Up to 90 days
Secondary outcome [8] 0 0
Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS)
Timepoint [8] 0 0
Day 21 and Day 90
Secondary outcome [9] 0 0
Assessment of Neurological function by the modified Rankin Scale (mRS)
Timepoint [9] 0 0
Day 21 and Day 90
Secondary outcome [10] 0 0
Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA)
Timepoint [10] 0 0
Day 21 and Day 90
Secondary outcome [11] 0 0
Incidence of Adverse Events (AEs)
Timepoint [11] 0 0
First dose up to 97 days
Secondary outcome [12] 0 0
Incidence of Serious Adverse Events (SAEs)
Timepoint [12] 0 0
First dose up to 97 days
Secondary outcome [13] 0 0
Change from Baseline in Heart Rate
Timepoint [13] 0 0
Up to 90 Days
Secondary outcome [14] 0 0
Change from Baseline in Blood Pressure
Timepoint [14] 0 0
Up to 90 Days
Secondary outcome [15] 0 0
Change from Baseline in Respiratory Rate
Timepoint [15] 0 0
Up to 90 Days
Secondary outcome [16] 0 0
Change from Baseline in Body Temperature
Timepoint [16] 0 0
Up to 90 Days
Secondary outcome [17] 0 0
Incidence of Abnormalities in Physical Examination
Timepoint [17] 0 0
Up to 90 days
Secondary outcome [18] 0 0
Incidence of Electrocardiogram (ECG) abnormalities
Timepoint [18] 0 0
Up to 90 Days
Secondary outcome [19] 0 0
Change from baseline in Clinical Laboratory Value of blood
Timepoint [19] 0 0
Up to 90 Days
Secondary outcome [20] 0 0
Change from baseline in Clinical Laboratory Value of Urine
Timepoint [20] 0 0
Up to 90 Days
Secondary outcome [21] 0 0
Change from baseline in Clinical Laboratory Value of Blood Serum
Timepoint [21] 0 0
Up to 90 Days
Secondary outcome [22] 0 0
Change from Baseline in Estimated Clearance (CL)
Timepoint [22] 0 0
Up to 90 Days
Secondary outcome [23] 0 0
Change from Baseline in Volume of Distribution (Vd)
Timepoint [23] 0 0
Up to 90 days
Secondary outcome [24] 0 0
Percent change from baseline in aPTT clotting activity during treatment
Timepoint [24] 0 0
Up to 90 Days
Secondary outcome [25] 0 0
Percent change from baseline in Factor XI clotting activity during treatment
Timepoint [25] 0 0
Up to 90 Days

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



- 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
Minimum age
40 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Local Institution - Liverpool
Recruitment hospital [2] 0 0
Local Institution - Randwick
Recruitment hospital [3] 0 0
Local Institution - Southport
Recruitment hospital [4] 0 0
Local Institution - Adelaide
Recruitment hospital [5] 0 0
Local Institution - Launceston
Recruitment hospital [6] 0 0
Local Institution - Clayton
Recruitment hospital [7] 0 0
Local Institution - Heidelberg
Recruitment hospital [8] 0 0
Local Institution - Midland
Recruitment hospital [9] 0 0
Local Institution - Murdoch
Recruitment postcode(s) [1] 0 0
1871 - Liverpool
Recruitment postcode(s) [2] 0 0
2031 - Randwick
Recruitment postcode(s) [3] 0 0
4215 - Southport
Recruitment postcode(s) [4] 0 0
5000 - Adelaide
Recruitment postcode(s) [5] 0 0
7250 - Launceston
Recruitment postcode(s) [6] 0 0
3168 - Clayton
Recruitment postcode(s) [7] 0 0
3084 - Heidelberg
Recruitment postcode(s) [8] 0 0
6056 - Midland
Recruitment postcode(s) [9] 0 0
6150 - Murdoch
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Delaware
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Georgia
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Maryland
Country [10] 0 0
United States of America
State/province [10] 0 0
Massachusetts
Country [11] 0 0
United States of America
State/province [11] 0 0
Michigan
Country [12] 0 0
United States of America
State/province [12] 0 0
Minnesota
Country [13] 0 0
United States of America
State/province [13] 0 0
Missouri
Country [14] 0 0
United States of America
State/province [14] 0 0
Montana
Country [15] 0 0
United States of America
State/province [15] 0 0
New Jersey
Country [16] 0 0
United States of America
State/province [16] 0 0
New York
Country [17] 0 0
United States of America
State/province [17] 0 0
North Carolina
Country [18] 0 0
United States of America
State/province [18] 0 0
Ohio
Country [19] 0 0
United States of America
State/province [19] 0 0
Oklahoma
Country [20] 0 0
United States of America
State/province [20] 0 0
Oregon
Country [21] 0 0
United States of America
State/province [21] 0 0
Pennsylvania
Country [22] 0 0
United States of America
State/province [22] 0 0
South Carolina
Country [23] 0 0
United States of America
State/province [23] 0 0
Tennessee
Country [24] 0 0
United States of America
State/province [24] 0 0
Texas
Country [25] 0 0
United States of America
State/province [25] 0 0
Wisconsin
Country [26] 0 0
Argentina
State/province [26] 0 0
Buenos Aires
Country [27] 0 0
Argentina
State/province [27] 0 0
Santa Fe
Country [28] 0 0
Austria
State/province [28] 0 0
Feldbach
Country [29] 0 0
Austria
State/province [29] 0 0
Klagenfurt Am Woerthersee
Country [30] 0 0
Austria
State/province [30] 0 0
St. Polten
Country [31] 0 0
Austria
State/province [31] 0 0
Vocklabruck
Country [32] 0 0
Austria
State/province [32] 0 0
Wien
Country [33] 0 0
Belgium
State/province [33] 0 0
Brasschaat
Country [34] 0 0
Belgium
State/province [34] 0 0
Brugge
Country [35] 0 0
Belgium
State/province [35] 0 0
Brussel
Country [36] 0 0
Belgium
State/province [36] 0 0
Bruxelles
Country [37] 0 0
Belgium
State/province [37] 0 0
Edegem
Country [38] 0 0
Belgium
State/province [38] 0 0
Gent
Country [39] 0 0
Belgium
State/province [39] 0 0
Kortrijk
Country [40] 0 0
Belgium
State/province [40] 0 0
Leuven
Country [41] 0 0
Belgium
State/province [41] 0 0
Montegnee
Country [42] 0 0
Belgium
State/province [42] 0 0
Yvoir
Country [43] 0 0
Brazil
State/province [43] 0 0
Ceara
Country [44] 0 0
Brazil
State/province [44] 0 0
Minas Gerais
Country [45] 0 0
Brazil
State/province [45] 0 0
Parana
Country [46] 0 0
Brazil
State/province [46] 0 0
RIO Grande DO SUL
Country [47] 0 0
Brazil
State/province [47] 0 0
Santa Catarina
Country [48] 0 0
Brazil
State/province [48] 0 0
SAO Paulo
Country [49] 0 0
Canada
State/province [49] 0 0
Alberta
Country [50] 0 0
Canada
State/province [50] 0 0
British Columbia
Country [51] 0 0
Canada
State/province [51] 0 0
Ontario
Country [52] 0 0
Canada
State/province [52] 0 0
Quebec
Country [53] 0 0
Chile
State/province [53] 0 0
Los Rios
Country [54] 0 0
Chile
State/province [54] 0 0
Valparaiso
Country [55] 0 0
Chile
State/province [55] 0 0
Los Angeles
Country [56] 0 0
China
State/province [56] 0 0
Beijing
Country [57] 0 0
China
State/province [57] 0 0
Guangdong
Country [58] 0 0
China
State/province [58] 0 0
Heilongjiang
Country [59] 0 0
China
State/province [59] 0 0
Henan
Country [60] 0 0
China
State/province [60] 0 0
Jiangsu
Country [61] 0 0
China
State/province [61] 0 0
Jilin
Country [62] 0 0
China
State/province [62] 0 0
Liaoning
Country [63] 0 0
China
State/province [63] 0 0
Shandong
Country [64] 0 0
China
State/province [64] 0 0
Haikou
Country [65] 0 0
Czechia
State/province [65] 0 0
Brno
Country [66] 0 0
Czechia
State/province [66] 0 0
Ceske Budejovice
Country [67] 0 0
Czechia
State/province [67] 0 0
Jihlava
Country [68] 0 0
Czechia
State/province [68] 0 0
Olomouc
Country [69] 0 0
Czechia
State/province [69] 0 0
Ostrava - Vitkovice
Country [70] 0 0
Czechia
State/province [70] 0 0
Prague
Country [71] 0 0
Denmark
State/province [71] 0 0
Aalborg
Country [72] 0 0
Denmark
State/province [72] 0 0
Aarhus N
Country [73] 0 0
Denmark
State/province [73] 0 0
Copenhagen
Country [74] 0 0
Denmark
State/province [74] 0 0
Glostrup
Country [75] 0 0
Denmark
State/province [75] 0 0
Herlev
Country [76] 0 0
Finland
State/province [76] 0 0
Helsinki
Country [77] 0 0
Finland
State/province [77] 0 0
Lappeenranta
Country [78] 0 0
Finland
State/province [78] 0 0
Turku
Country [79] 0 0
France
State/province [79] 0 0
Bordeaux
Country [80] 0 0
France
State/province [80] 0 0
Bourg-en-Bresse
Country [81] 0 0
France
State/province [81] 0 0
Brest
Country [82] 0 0
France
State/province [82] 0 0
Caen
Country [83] 0 0
France
State/province [83] 0 0
Creteil
Country [84] 0 0
France
State/province [84] 0 0
Lille
Country [85] 0 0
France
State/province [85] 0 0
Limoges
Country [86] 0 0
France
State/province [86] 0 0
Marseille
Country [87] 0 0
France
State/province [87] 0 0
Nancy
Country [88] 0 0
France
State/province [88] 0 0
Nimes
Country [89] 0 0
France
State/province [89] 0 0
Paris Cedex 10
Country [90] 0 0
France
State/province [90] 0 0
Paris
Country [91] 0 0
France
State/province [91] 0 0
Rouen
Country [92] 0 0
France
State/province [92] 0 0
Toulouse Cedex 9
Country [93] 0 0
Germany
State/province [93] 0 0
Altenburg
Country [94] 0 0
Germany
State/province [94] 0 0
Berlin
Country [95] 0 0
Germany
State/province [95] 0 0
Bielefeld
Country [96] 0 0
Germany
State/province [96] 0 0
Bonn
Country [97] 0 0
Germany
State/province [97] 0 0
Bremen
Country [98] 0 0
Germany
State/province [98] 0 0
Dresden
Country [99] 0 0
Germany
State/province [99] 0 0
Erlangen
Country [100] 0 0
Germany
State/province [100] 0 0
Essen
Country [101] 0 0
Germany
State/province [101] 0 0
Frankfurt am Main
Country [102] 0 0
Germany
State/province [102] 0 0
Fulda
Country [103] 0 0
Germany
State/province [103] 0 0
Gie?en
Country [104] 0 0
Germany
State/province [104] 0 0
Hamburg
Country [105] 0 0
Germany
State/province [105] 0 0
Hannover
Country [106] 0 0
Germany
State/province [106] 0 0
Heidelberg
Country [107] 0 0
Germany
State/province [107] 0 0
Leipzig
Country [108] 0 0
Germany
State/province [108] 0 0
Lubeck
Country [109] 0 0
Germany
State/province [109] 0 0
Magdeburg
Country [110] 0 0
Germany
State/province [110] 0 0
Minden
Country [111] 0 0
Germany
State/province [111] 0 0
Munster
Country [112] 0 0
Germany
State/province [112] 0 0
Osnabruck
Country [113] 0 0
Germany
State/province [113] 0 0
Potsdam
Country [114] 0 0
Germany
State/province [114] 0 0
Regensburg
Country [115] 0 0
Germany
State/province [115] 0 0
Sande
Country [116] 0 0
Germany
State/province [116] 0 0
Siegen
Country [117] 0 0
Germany
State/province [117] 0 0
Sindelfingen
Country [118] 0 0
Germany
State/province [118] 0 0
Tubingen
Country [119] 0 0
Germany
State/province [119] 0 0
Ulm
Country [120] 0 0
Greece
State/province [120] 0 0
Athens
Country [121] 0 0
Greece
State/province [121] 0 0
Heraklion
Country [122] 0 0
Greece
State/province [122] 0 0
Ioannina
Country [123] 0 0
Greece
State/province [123] 0 0
Larissa,
Country [124] 0 0
Greece
State/province [124] 0 0
Larissa
Country [125] 0 0
Greece
State/province [125] 0 0
Patras
Country [126] 0 0
Greece
State/province [126] 0 0
Pireaus
Country [127] 0 0
Greece
State/province [127] 0 0
Thessaloniki
Country [128] 0 0
Hungary
State/province [128] 0 0
Budapest
Country [129] 0 0
Hungary
State/province [129] 0 0
Debrecen
Country [130] 0 0
Hungary
State/province [130] 0 0
Gyor
Country [131] 0 0
Hungary
State/province [131] 0 0
Kistarcsa
Country [132] 0 0
Hungary
State/province [132] 0 0
Miskolc
Country [133] 0 0
Hungary
State/province [133] 0 0
Nyiregyhaza
Country [134] 0 0
Hungary
State/province [134] 0 0
Pecs
Country [135] 0 0
Hungary
State/province [135] 0 0
Szeged
Country [136] 0 0
Hungary
State/province [136] 0 0
Zalaegerszeg
Country [137] 0 0
Israel
State/province [137] 0 0
Bear Sheva
Country [138] 0 0
Israel
State/province [138] 0 0
Haifa
Country [139] 0 0
Israel
State/province [139] 0 0
Jerusalem
Country [140] 0 0
Israel
State/province [140] 0 0
Nahariya
Country [141] 0 0
Israel
State/province [141] 0 0
Petach Tikva
Country [142] 0 0
Israel
State/province [142] 0 0
Ramat-Gan
Country [143] 0 0
Israel
State/province [143] 0 0
Tel Aviv
Country [144] 0 0
Italy
State/province [144] 0 0
Ancona
Country [145] 0 0
Italy
State/province [145] 0 0
Baggiovara
Country [146] 0 0
Italy
State/province [146] 0 0
Bologna
Country [147] 0 0
Italy
State/province [147] 0 0
Cagliari
Country [148] 0 0
Italy
State/province [148] 0 0
Citta di Castello
Country [149] 0 0
Italy
State/province [149] 0 0
Genova
Country [150] 0 0
Italy
State/province [150] 0 0
Milano
Country [151] 0 0
Italy
State/province [151] 0 0
Negrar
Country [152] 0 0
Italy
State/province [152] 0 0
Pavia
Country [153] 0 0
Italy
State/province [153] 0 0
Perugia
Country [154] 0 0
Italy
State/province [154] 0 0
Roma
Country [155] 0 0
Italy
State/province [155] 0 0
Rome
Country [156] 0 0
Italy
State/province [156] 0 0
Verona
Country [157] 0 0
Italy
State/province [157] 0 0
Vibo Valentia
Country [158] 0 0
Japan
State/province [158] 0 0
Aichi
Country [159] 0 0
Japan
State/province [159] 0 0
Chiba
Country [160] 0 0
Japan
State/province [160] 0 0
Fukuoka
Country [161] 0 0
Japan
State/province [161] 0 0
Fukushima
Country [162] 0 0
Japan
State/province [162] 0 0
Gifu
Country [163] 0 0
Japan
State/province [163] 0 0
Gunma
Country [164] 0 0
Japan
State/province [164] 0 0
Hiroshima
Country [165] 0 0
Japan
State/province [165] 0 0
Hyogo
Country [166] 0 0
Japan
State/province [166] 0 0
Ishikawa
Country [167] 0 0
Japan
State/province [167] 0 0
Kagoshima
Country [168] 0 0
Japan
State/province [168] 0 0
Kanagawa
Country [169] 0 0
Japan
State/province [169] 0 0
Miyagi
Country [170] 0 0
Japan
State/province [170] 0 0
Nagasaki
Country [171] 0 0
Japan
State/province [171] 0 0
Niigata
Country [172] 0 0
Japan
State/province [172] 0 0
Osaka
Country [173] 0 0
Japan
State/province [173] 0 0
Saitama
Country [174] 0 0
Japan
State/province [174] 0 0
Tochigi
Country [175] 0 0
Japan
State/province [175] 0 0
Tokyo
Country [176] 0 0
Japan
State/province [176] 0 0
Yamaguchi
Country [177] 0 0
Japan
State/province [177] 0 0
Kyoto
Country [178] 0 0
Japan
State/province [178] 0 0
Saga
Country [179] 0 0
Korea, Republic of
State/province [179] 0 0
Anyang
Country [180] 0 0
Korea, Republic of
State/province [180] 0 0
Busan
Country [181] 0 0
Korea, Republic of
State/province [181] 0 0
Daegu
Country [182] 0 0
Korea, Republic of
State/province [182] 0 0
Goyang-si
Country [183] 0 0
Korea, Republic of
State/province [183] 0 0
Gwangju
Country [184] 0 0
Korea, Republic of
State/province [184] 0 0
Gyeonggi-Do
Country [185] 0 0
Korea, Republic of
State/province [185] 0 0
Incheon
Country [186] 0 0
Korea, Republic of
State/province [186] 0 0
Seoul
Country [187] 0 0
Mexico
State/province [187] 0 0
Distrito Federal
Country [188] 0 0
Mexico
State/province [188] 0 0
Jalisco
Country [189] 0 0
Mexico
State/province [189] 0 0
Nuevo LEON
Country [190] 0 0
Mexico
State/province [190] 0 0
Sinaloa
Country [191] 0 0
Mexico
State/province [191] 0 0
Durango
Country [192] 0 0
Norway
State/province [192] 0 0
Bergen
Country [193] 0 0
Norway
State/province [193] 0 0
Gr?lum
Country [194] 0 0
Norway
State/province [194] 0 0
Kristiansand
Country [195] 0 0
Norway
State/province [195] 0 0
L?renskog
Country [196] 0 0
Norway
State/province [196] 0 0
Oslo
Country [197] 0 0
Norway
State/province [197] 0 0
Stavanger
Country [198] 0 0
Poland
State/province [198] 0 0
Bydgoszcz
Country [199] 0 0
Poland
State/province [199] 0 0
Chelm
Country [200] 0 0
Poland
State/province [200] 0 0
Gdansk
Country [201] 0 0
Poland
State/province [201] 0 0
Grodzisk Mazowieciki
Country [202] 0 0
Poland
State/province [202] 0 0
Katowice
Country [203] 0 0
Poland
State/province [203] 0 0
Konskie
Country [204] 0 0
Poland
State/province [204] 0 0
Lodz
Country [205] 0 0
Poland
State/province [205] 0 0
Olsztyn
Country [206] 0 0
Poland
State/province [206] 0 0
Sandomierz
Country [207] 0 0
Poland
State/province [207] 0 0
Skarzysko-Kamienna
Country [208] 0 0
Poland
State/province [208] 0 0
Walcz
Country [209] 0 0
Poland
State/province [209] 0 0
Warszawa
Country [210] 0 0
Poland
State/province [210] 0 0
Wejherowo
Country [211] 0 0
Russian Federation
State/province [211] 0 0
Barnaul
Country [212] 0 0
Russian Federation
State/province [212] 0 0
Kemerovo
Country [213] 0 0
Russian Federation
State/province [213] 0 0
Moscow
Country [214] 0 0
Russian Federation
State/province [214] 0 0
Novosibirsk
Country [215] 0 0
Russian Federation
State/province [215] 0 0
Smolensk
Country [216] 0 0
Russian Federation
State/province [216] 0 0
St. Petersburg
Country [217] 0 0
Russian Federation
State/province [217] 0 0
Vladimir
Country [218] 0 0
Russian Federation
State/province [218] 0 0
Yaroslavl
Country [219] 0 0
Spain
State/province [219] 0 0
A Coruna
Country [220] 0 0
Spain
State/province [220] 0 0
Albacete
Country [221] 0 0
Spain
State/province [221] 0 0
Badalona
Country [222] 0 0
Spain
State/province [222] 0 0
Barcelona
Country [223] 0 0
Spain
State/province [223] 0 0
Cordoba
Country [224] 0 0
Spain
State/province [224] 0 0
L'Hospitalet de Llobregat
Country [225] 0 0
Spain
State/province [225] 0 0
Leon
Country [226] 0 0
Spain
State/province [226] 0 0
Lleida
Country [227] 0 0
Spain
State/province [227] 0 0
Madrid
Country [228] 0 0
Spain
State/province [228] 0 0
Sabadell, Barcelona
Country [229] 0 0
Spain
State/province [229] 0 0
San Sebastian-Guipuzcoa
Country [230] 0 0
Spain
State/province [230] 0 0
Sant Joan Despi
Country [231] 0 0
Spain
State/province [231] 0 0
Sevilla
Country [232] 0 0
Spain
State/province [232] 0 0
Tarragona
Country [233] 0 0
Spain
State/province [233] 0 0
Terrassa
Country [234] 0 0
Spain
State/province [234] 0 0
Valencia
Country [235] 0 0
Spain
State/province [235] 0 0
Valladolid
Country [236] 0 0
Spain
State/province [236] 0 0
Vigo
Country [237] 0 0
Sweden
State/province [237] 0 0
Goteborg
Country [238] 0 0
Sweden
State/province [238] 0 0
Hassleholm
Country [239] 0 0
Sweden
State/province [239] 0 0
Malmo
Country [240] 0 0
Sweden
State/province [240] 0 0
Ume?
Country [241] 0 0
Sweden
State/province [241] 0 0
Uppsala
Country [242] 0 0
Switzerland
State/province [242] 0 0
Aarau
Country [243] 0 0
Switzerland
State/province [243] 0 0
Basel
Country [244] 0 0
Switzerland
State/province [244] 0 0
Bern
Country [245] 0 0
Switzerland
State/province [245] 0 0
Geneva
Country [246] 0 0
Switzerland
State/province [246] 0 0
Lausanne
Country [247] 0 0
Switzerland
State/province [247] 0 0
Zurich
Country [248] 0 0
United Kingdom
State/province [248] 0 0
Hampshire
Country [249] 0 0
United Kingdom
State/province [249] 0 0
South Yorkshire
Country [250] 0 0
United Kingdom
State/province [250] 0 0
Aberdeen
Country [251] 0 0
United Kingdom
State/province [251] 0 0
Ashford
Country [252] 0 0
United Kingdom
State/province [252] 0 0
Bath
Country [253] 0 0
United Kingdom
State/province [253] 0 0
Birmingham
Country [254] 0 0
United Kingdom
State/province [254] 0 0
Canterbury
Country [255] 0 0
United Kingdom
State/province [255] 0 0
Chester
Country [256] 0 0
United Kingdom
State/province [256] 0 0
Edinburgh
Country [257] 0 0
United Kingdom
State/province [257] 0 0
England
Country [258] 0 0
United Kingdom
State/province [258] 0 0
Glasgow
Country [259] 0 0
United Kingdom
State/province [259] 0 0
London
Country [260] 0 0
United Kingdom
State/province [260] 0 0
Luton
Country [261] 0 0
United Kingdom
State/province [261] 0 0
Nottingham
Country [262] 0 0
United Kingdom
State/province [262] 0 0
Staffordshire

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Bristol-Myers Squibb
Address
Country
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Janssen, LP
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT03766581
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bristol-Myers Squibb
Address 0 0
Bristol-Myers Squibb
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Recruiting sites have contact information. Please contact the sites directly. If there is no contact information
Address 0 0
Country 0 0
Phone 0 0
please email
Fax 0 0
Email 0 0
Clinical.Trials@bms.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT03766581