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

  • Clinicaltrials.gov identifier

    NCT03766581

  • Recruitment Status

    Active, not recruiting

  • First Posted

    December 6, 2018

  • Last update posted

    April 5, 2022

Save Trial

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:Acute Ischemic Stroke
    Transient Ischemic Attack (TIA)
  • Intervention/Treatment: Drug: BMS-986177
    Other: Placebo
    Drug: Clopidogrel
    Drug: Aspirin
  • Phase: Phase 2

Detailed Description

N/A

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 Study on BMS-986177 for the Prevention of a Stroke in Patients Receiving Aspirin and Clopidogrel
  • Actual Study Start Date: January 2019
  • Estimated Primary Completion Date: April 2022
  • Estimated Study Completion Date: April 2022

Arms and interventions

Arm Intervention/treatment
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
Placebo Comparator: BMS-986177 Placebo
Specified Dose on Specified Days		 Other: Placebo
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 [ Time Frame: Up to 90 days ]
  • Secondary Outcome Measures: 1. Event rate based on bleeding according to Bleeding Academic Research Consortium (BARC) Type 3 and 5 [ Time Frame: 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 [ Time Frame: Up to 90 days ]
  • 3. Rate of the composite of new ischemic stroke and new covert brain infarction during the treatment period [ Time Frame: Up to 90 days ]
  • 4. Location of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  • 5. Number of new FLAIR + DWI lesions [ Time Frame: Up to 90 days ]
  • 6. Volume of new FLAIR + DWI lesions [ Time Frame: 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 [ Time Frame: Up to 90 days ]
  • 8. Assessment of Stroke Severity by the National Institutes of Health Stroke Scale (NIHSS) [ Time Frame: Day 21 and Day 90 ]
  • 9. Assessment of Neurological function by the modified Rankin Scale (mRS) [ Time Frame: Day 21 and Day 90 ]
  • 10. Assessment of Cognitive function as by the Montreal Cognitive Assessment (MoCA) [ Time Frame: Day 21 and Day 90 ]
  • 11. Incidence of Adverse Events (AEs) [ Time Frame: First dose up to 97 days ]
  • 12. Incidence of Serious Adverse Events (SAEs) [ Time Frame: First dose up to 97 days ]
  • 13. Change from Baseline in Heart Rate [ Time Frame: Up to 90 Days ]
  • 14. Change from Baseline in Blood Pressure [ Time Frame: Up to 90 Days ]
  • 15. Change from Baseline in Respiratory Rate [ Time Frame: Up to 90 Days ]
  • 16. Change from Baseline in Body Temperature [ Time Frame: Up to 90 Days ]
  • 17. Incidence of Abnormalities in Physical Examination [ Time Frame: Up to 90 days ]
  • 18. Incidence of Electrocardiogram (ECG) abnormalities [ Time Frame: Up to 90 Days ]
  • 19. Change from baseline in Clinical Laboratory Value of blood [ Time Frame: Up to 90 Days ]
  • 20. Change from baseline in Clinical Laboratory Value of Urine [ Time Frame: Up to 90 Days ]
  • 21. Change from baseline in Clinical Laboratory Value of Blood Serum [ Time Frame: Up to 90 Days ]
  • 22. Change from Baseline in Estimated Clearance (CL) [ Time Frame: Up to 90 Days ]
  • 23. Change from Baseline in Volume of Distribution (Vd) [ Time Frame: Up to 90 days ]
  • 24. Percent change from baseline in aPTT clotting activity during treatment [ Time Frame: Up to 90 Days ]
  • 25. Percent change from baseline in Factor XI clotting activity during treatment [ Time Frame: Up to 90 Days ]

Eligibility Criteria

  • Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Criteria

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

Contacts

Locations

United States, Alabama
University of Alabama at Birmingham: The Kirklin Clinic
Birmingham

United States, California
Glendale Adventist Medical Center
Glendale

United States, California
Long Beach Memorial Medical Center
Long Beach

United States, California
Kaiser Permanente Los Angeles Medical Center
Los Angeles

United States, California
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles

United States, California
UC Davis Health
Sacramento

United States, California
Stanford Stroke Center
Stanford

United States, California
Harbor UCLA Medical Center
Torrance

United States, Delaware
Christiana Care Health System
Newark

United States, Florida
UF Health Neurovascular Hospital
Gainesville

United States, Florida
Sarasota Memorial Hospital
Sarasota

United States, Florida
University of South Florida
Tampa

United States, Georgia
Augusta University
Augusta

United States, Hawaii
The Queens Medical Center
Honolulu

United States, Illinois
University of Illinois at Chicago
Chicago

United States, Illinois
University of Illinois Hospital & Health Sciences System
Chicago

United States, Illinois
Alexian Brothers Health System
Elk Grove Village

United States, Illinois
Mercyhealth Javon Bea Hospital- Riverside
Rockford

United States, Kentucky
University of Louisville Hospital
Louisville

United States, Louisiana
Ochsner Clinic Foundation
New Orleans

United States, Maryland
Sinai Hospital of Baltimore
Baltimore

United States, Massachusetts
Local Institution
Boston

United States, Massachusetts
Beth Israel Deaconess Medical Center
Boston

United States, Michigan
Local Institution
Detroit

United States, Michigan
Henry Ford Hospital
Detroit

United States, Michigan
Local Institution
Detroit

United States, Michigan
Ascension Providence Hospital - Novi Campus
Farmington Hills

United States, Minnesota
Local Institution
Minneapolis

United States, Missouri
Local Institution
Kansas City

United States, Missouri
Local Institution
Saint Louis

United States, Missouri
Barnes Jewish Hospital
Saint Louis

United States, Missouri
Washington University School Of Medicine
Saint Louis

United States, Montana
Advanced Neurology Specialists PLLC
Great Falls

United States, New Jersey
Cooper University Hospital
Camden

United States, New Jersey
Robert Wood Johnson Medical School
New Brunswick

United States, New York
SUNY Downstate Health Science University
Brooklyn

United States, New York
Local Institution
Buffalo

United States, New York
Local Institution
New York

United States, New York
Columbia University Medical Center
New York

United States, North Carolina
Duke University Medical Center
Butner

United States, North Carolina
University of North Carolina at Chapel Hill
Chapel Hill

United States, North Carolina
Guilford Neurologic Research, PA
Greensboro

United States, North Carolina
Local Institution
Winston-Salem

United States, Ohio
University Hospitals Cleveland Medical Center
Cleveland

United States, Ohio
The Cleveland Clinic Foundation
Cleveland

United States, Ohio
The Ohio State University Wexner Medical Center
Columbus

United States, Oklahoma
INTEGRIS Baptist Medical Center
Oklahoma City

United States, Oregon
Oregon Health and Science University
Portland

United States, Pennsylvania
Abington Memorial Hospital
Abington

United States, Pennsylvania
Local Institution
Allentown

United States, Pennsylvania
Local Institution
Camp Hill

United States, Pennsylvania
UPMC Hamot
Erie

United States, Pennsylvania
Hospital of The University of Pennsylvania
Philadelphia

United States, Pennsylvania
Temple University Hospital
Philadelphia

United States, Pennsylvania
WellSpan York Hospital
York

United States, South Carolina
Prisma Health-Midlands
Columbia

United States, Tennessee
Vanderbilt University Medical Center
Nashville

United States, Texas
Dell Seton Medical School at The University of Texas - Stroke Institute
Austin

United States, Texas
Neurology Consultants of Dallas, PA
Dallas

United States, Texas
Local Institution
Dallas

United States, Texas
University Medical center of El Paso
El Paso

United States, Texas
Methodist Neurological Institute
Houston

United States, Texas
University of Texas Health Science Center at Houston
Houston

United States, Texas
Baylor Scott and White Research Institute
Temple

United States, Virginia
Local Institution
Richmond

United States, Wisconsin
Local Institution
Milwaukee

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Buenos Aires
Local Institution
Caba

Argentina, Buenos Aires
Local Institution
Ciudad Autonoma de Buenos Aires

Argentina, Buenos Aires
Local Institution
Lomas de Zamora

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Buenos Aires

Argentina
Local Institution
Santa Fe

Australia, New South Wales
Local Institution
Randwick

Australia, New South Wales
Local Institution
Sydney

Australia, Queensland
Local Institution
Southport

Australia, South Australia
Local Institution
Adelaide

Australia, Tasmania
Local Institution
Launceston

Australia, Victoria
Local Institution
Clayton

Australia, Victoria
Local Institution
Heidelberg

Australia, Western Australia
Local Institution
Murdoch

Austria
Local Institution
Klagenfurt Am Woerthersee

Austria
Local Institution
St. Pölten

Austria
Local Institution
Vocklabruck

Austria
Local Institution
Wien

Belgium, Namur
Local Institution - 0192
Yvoir

Belgium
Local Institution
Brasschaat

Belgium
Local Institution
Bruges

Belgium
Local Institution
Brussels

Belgium
Local Institution
Brussels

Belgium
Local Institution
Brussel

Belgium
Local Institution
Bruxelles

Belgium
Local Institution
Edegem

Belgium
Local Institution
Gent

Belgium
Local Institution
Kortrijk

Belgium
Local Institution
Leuven

Belgium
Local Institution
Liege

Brazil, Ceara
Local Institution
Fortaleza

Brazil, Minas Gerais
Local Institution
Uberaba

Brazil, Parana
Local Institution
Curitiba

Brazil, Rio Grande Do Sul
Local Institution
Porto Alegre

Brazil, Santa Catarina
Local Institution
Joinville

Brazil, SAO Paulo
Local Institution
Botucatu

Brazil, SAO Paulo
Local Institution
Campinas

Brazil, SAO Paulo
Local Institution
Ribeirao Preto

Brazil, SAO Paulo
Local Institution
Santo Andre

Brazil, SAO Paulo
Local Institution
São Paulo

Brazil, SAO Paulo
Local Institution
São Paulo

Canada, Alberta
Local Institution
Calgary

Canada, Alberta
Local Institution
Edmonton

Canada, Alberta
Local Institution
Lethbridge

Canada, British Columbia
Local Institution
New Westminster

Canada, British Columbia
Local Institution
Vancouver

Canada, Ontario
Local Institution
Hamilton

Canada, Ontario
Local Institution
Kingston

Canada, Ontario
Local Institution
London

Canada, Ontario
Local Institution
Toronto

Canada, Ontario
Local Institution
Toronto

Canada, Quebec
Local Institution
Chicoutimi

Canada, Quebec
Local Institution
Greenfield Park

Canada, Quebec
Local Institution
Montreal

Canada
Local Institution
Quebec

Chile, Los Rios
Local Institution
Valdivia

Chile, Valparaiso
Local Institution
Vina del Mar

Chile
Local Institution
Los Angeles

China, Beijing
Local Institution
Beijing

China, Guangdong
Local Institution
Guangzhou

China, Hainan
Local Institution
Haikou

China, Heilongjiang
Local Institution
Daqing

China, Henan
Local Institution
Zhengzhou

China, Jiangsu
Local Institution
Nantong

China, Jiangsu
Local Institution
Yangzhou

China, Jilin
Local Institution
Changchun

China, Liaoning
Local Institution
Shenyang

China, Shandong
Local Institution
Qingdao

China, Shandong
Local Institution
YanTai

China, Zhejiang
Local Institution
Wenzhou

Czechia
Local Institution
Brno

Czechia
Local Institution
Ceske Budejovice

Czechia
Local Institution
Jihlava

Czechia
Local Institution
Olomouc

Czechia
Local Institution
Ostrava

Czechia
Local Institution
Praha 2

Denmark
Local Institution
Aalborg

Denmark
Local Institution
Aarhus N

Denmark
Local Institution
Copenhagen

Denmark
Local Institution
Glostrup

Denmark
Local Institution
Herlev

Finland, Etelä-Suomen Lääni
Local Institution - 0111
Helsinki

Finland
Local Institution
Lappeenranta

Finland
Local Institution
Turku

France
Local Institution
Bordeaux

France
Local Institution
Bourg-en-Bresse

France
Local Institution
Brest

France
Local Institution
Caen

France
Local Institution
Créteil

France
Local Institution
Lille

France
Local Institution
Limoges Cedex

France
Local Institution
Marseille

France
Local Institution
Montpellier Cedex 5

France
Local Institution
Nancy

France
Local Institution
Nimes

France
Local Institution
Paris cedex 10

France
Local Institution
Paris

France
Local Institution
Paris

France
Local Institution
Paris

France
Local Institution
Rouen Cedex

France
Local Institution
Toulouse Cedex 9

Germany
Local Institution
Altenburg

Germany
Local Institution
Berlin

Germany
Local Institution
Berlin

Germany
Local Institution
Bielefeld

Germany
Local Institution
Bonn

Germany
Local Institution
Bremen

Germany
Local Institution
Dresden

Germany
Local Institution
Erlangen

Germany
Local Institution
Essen

Germany
Local Institution
Frankfurt Am Maim

Germany
Local Institution
Frankfurt am Main

Germany
Local Institution
Gießen

Germany
Local Institution - 0056
Hamburg

Germany
Local Institution
Hamburg

Germany
Local Institution
Hamburg

Germany
Local Institution
Hannover

Germany
Local Institution
Heidelberg

Germany
Local Institution
Leipzig

Germany
Local Institution
Lübeck

Germany
Local Institution
Magdeburg

Germany
Local Institution
Minden

Germany
Local Institution
Munster

Germany
Local Institution
Osnabruck

Germany
Local Institution
Regensburg

Germany
Local Institution
Sande

Germany
Local Institution
Siegen

Germany
Local Institution
Sindelfingen

Germany
Local Institution
Tubingen

Germany
Local Institution
Ulm

Greece, Attiki
Local Institution - 0438
Athina

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution - 0373
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Athens

Greece
Local Institution
Crete

Greece
Local Institution - 0333
Ioannina

Greece
Local Institution - 0365
Ioannina

Greece
Local Institution
Ioannina

Greece
Local Institution
Larissa,

Greece
Local Institution
Larissa

Greece
Local Institution
Larissa

Greece
Local Institution
Neo Faliro

Greece
Local Institution
Patras

Greece
Local Institution
Pireaus

Greece
Local Institution
Thessaloniki

Greece
Local Institution
Thessaloniki

Greece
Local Institution
Thessaloniki

Greece
Local Institution
Thessaloniki

Greece
Local Institution
Thessaloniki

Hong Kong
Local Institution
Hong Kong

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Budapest

Hungary
Local Institution
Debrecen

Hungary
Local Institution
Gyor

Hungary
Local Institution
Kistarcsa

Hungary
Local Institution
Kisvárda

Hungary
Local Institution
Miskolc

Hungary
Local Institution
Nyíregyháza

Hungary
Local Institution
Pecs

Hungary
Local Institution - 0133
Szeged

Hungary
Local Institution
Zalaegerszeg

Israel
Local Institution
Beer-Sheva

Israel
Local Institution
Haifa

Israel
Local Institution
Haifa

Israel
Local Institution
Jerusalem

Israel
Local Institution
Jerusalem

Israel
Local Institution
Nahariya

Israel
Local Institution
Petach Tikva

Israel
Local Institution
Ramat-Gan

Israel
Local Institution
Tel Aviv

Italy, Marche
Local Institution - 0151
Ancona

Italy
Local Institution
Bologna

Italy
Local Institution
Cagliari

Italy
Local Institution
Genova

Italy
Local Institution
Milano

Italy
Local Institution
Modena

Italy
Local Institution
Negrar

Italy
Local Institution
Pavia

Italy
Local Institution
Perugia

Italy
Local Institution
Perugia

Italy
Local Institution
Roma

Italy
Local Institution
Rome

Italy
Local Institution
Verona

Italy
Local Institution
Vibo Valentia

Japan, Aichi
Local Institution
Kasugai

Japan, Aichi
Local Institution
Nagoya-shi

Japan, Aichi
Local Institution
Toyoake Shi

Japan, Aichi
Local Institution
Toyohashi-shi

Japan, Aichi
Local Institution
Toyota-shi

Japan, Chiba
Local Institution
Sakura-shi

Japan, Fukuoka
Local Institution
Chikushino-shi

Japan, Fukuoka
Local Institution
Kasuga-shi

Japan, Fukuoka
Local Institution
Kitakyushu-shi

Japan, Fukuoka
Local Institution
Kitakyushu-shi

Japan, Fukuoka
Local Institution
Kitakyushu

Japan, Fukuoka
Local Institution
Koga-shi

Japan, Fukuoka
Local Institution
Kurume City

Japan, Fukushima
Local Institution
Aizuwakamatsu-shi

Japan, Gifu
Local Institution
Takayama-shi

Japan, Gunma
Local Institution
Isesaki-shi

Japan, Hiroshima
Local Institution
Aki-gun

Japan, Hiroshima
Local Institution
Higashihiroshima-shi

Japan, Hiroshima
Local Institution
Hiroshima-shi

Japan, Hyogo
Local Institution
Kobe-City

Japan, Ishikawa
Local Institution
Kanazawa

Japan, Ishikawa
Local Institution
Komatsu

Japan, Kagoshima
Local Institution
Kagoshima-shi

Japan, Kanagawa
Local Institution
Kawasaki-city

Japan, Kanagawa
Local Institution
Kawasaki

Japan, Miyagi
Local Institution
Sendai-shi

Japan, Miyagi
Local Institution
Sendai

Japan, Nagasaki
Local Institution
Nagasaki-shi

Japan, Osaka
Local Institution
Izumisano-shi

Japan, Osaka
Local Institution
Kishiwada

Japan, Osaka
Local Institution
Matsubara

Japan, Osaka
Local Institution
Sakai-shi

Japan, Osaka
Local Institution
Suita-shi

Japan, Osaka
Local Institution
Suita

Japan, Saitama
Local Institution
Hidaka

Japan, Tochigi
Local Institution
Shimotsuke-shi

Japan, Tokyo
Local Institution
Bunkyo-ku

Japan, Tokyo
Local Institution
Hachioji

Japan, Tokyo
Local Institution
Meguro-ku

Japan, Tokyo
Local Institution
Minato-ku

Japan, Tokyo
Local Institution
Minato-ku

Japan, Tokyo
Local Institution
Mitaka-shi

Japan, Tokyo
Local Institution - 0298
Shinagawa-ku

Japan, Tokyo
Local Institution
Shinjuku-Ku

Japan, Tokyo
Local Institution
Tachikawa-shi

Japan, Yamaguchi
Local Institution
Shimonoseki-Shi

Japan
Local Institution
Fukuoka

Japan
Local Institution
Fukuoka

Japan
Local Institution
Kyoto

Japan
Local Institution
Osaka

Japan
Local Institution
Osaka

Japan
Local Institution
Osaka

Japan
Local Institution
Saga

Korea, Republic of, Gyeonggido
Local Institution - 0094
Goyang-si

Korea, Republic of
Local Institution
Anyang

Korea, Republic of
Local Institution
Busan

Korea, Republic of
Local Institution
Busan

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Daegu

Korea, Republic of
Local Institution
Gwangju

Korea, Republic of
Local Institution
Incheon

Korea, Republic of
Local Institution
Seongnam-si

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Korea, Republic of
Local Institution
Seoul

Mexico, Distrito Federal
Local Institution
Ciudad de Mexico

Mexico, Distrito Federal
Local Institution
Mexico

Mexico, Jalisco
Local Institution
Guadalajara

Mexico, Nuevo LEON
Local Institution
Monterrey

Mexico, Sinaloa
Local Institution
Culiacan

Mexico
Local Institution
Durango

Norway
Local Institution
Bergen

Norway
Local Institution
Grålum

Norway
Local Institution
Kristiansand

Norway
Local Institution
Lørenskog

Norway
Local Institution
Oslo

Norway
Local Institution
Stavanger

Poland
Local Institution
Bydgoszcz

Poland
Local Institution
Chelm

Poland
Local Institution
Gdansk

Poland
Local Institution
Grodzisk Mazowieciki

Poland
Local Institution
Katowice

Poland
Local Institution
Konskie

Poland
Local Institution
Lodz

Poland
Local Institution
Olsztyn

Poland
Local Institution
Sandomierz

Poland
Local Institution
Skarzysko-Kamienna

Poland
Local Institution
Walcz

Poland
Local Institution
Warszawa

Poland
Local Institution
Warszawa

Poland
Local Institution
Warszawa

Poland
Local Institution
Wejherowo

Russian Federation
Local Institution
Barnaul

Russian Federation
Local Institution
Kemerovo

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Moscow

Russian Federation
Local Institution
Novosibirsk

Russian Federation
Local Institution
Smolensk

Russian Federation
Local Institution
St. Petersburg

Russian Federation
Local Institution
Yaroslavl

Spain, Castilla Y León
Local Institution - 0372
León

Spain
Local Institution
A Coruna

Spain
Local Institution
Albacete

Spain
Local Institution
Badalona

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Barcelona

Spain
Local Institution
Córdoba

Spain
Local Institution
Girona

Spain
Local Institution
L'Hospitalet de Llobregat

Spain
Local Institution
Lleida

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Madrid

Spain
Local Institution
Sabadell, Barcelona

Spain
Local Institution
San Sebastian

Spain
Local Institution
Sant Joan Despi

Spain
Local Institution
Santiago de Compostela

Spain
Local Institution
Sevilla

Spain
Local Institution
Sevilla

Spain
Local Institution
Tarragona

Spain
Local Institution
Terrassa

Spain
Local Institution
Valencia

Spain
Local Institution
Valladolid

Spain
Local Institution
Vigo

Sweden, Skane Lan
Local Institution - 0128
Malmö

Sweden
Local Institution
Göteborg

Sweden
Local Institution
Hassleholm

Sweden
Local Institution
Umea

Sweden
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Uppsala

Switzerland
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Aarau

Switzerland
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Basel

Switzerland
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Bern

Switzerland
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Geneve

Switzerland
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Lausanne

Switzerland
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Zurich

United Kingdom, Kent
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Canterbury

United Kingdom
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Aberdeen

United Kingdom
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Ashford

United Kingdom
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Bath

United Kingdom
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Chester

United Kingdom
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Edinburgh

United Kingdom
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Glasgow

United Kingdom
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Lancashire

United Kingdom
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London

United Kingdom
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London

United Kingdom
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Luton

United Kingdom
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Manchester

United Kingdom
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Nottingham

United Kingdom
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Sheffield

United Kingdom
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Staffordshire

Sponsors and Collaborators

Bristol-Myers Squibb

Janssen, LP

Investigators

Study Director: Bristol-Myers Squibb Bristol-Myers Squibb

More 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: April 5, 2022
  • Last Verified: April 2022
  • Studies a U.S. FDA-regulated Drug Product: Yes
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Ischemia
    Stroke
    Ischemic Stroke
    Ischemic Attack, Transient
    Cerebrovascular Disorders
    Brain Diseases     Central Nervous System Diseases
    Nervous System Diseases
    Vascular Diseases
    Cardiovascular Diseases
    Pathologic Processes
    Brain Ischemia