[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES] (SOCRATES)
May 12, 2017 updated by: AstraZeneca
A Randomised, Double-Blind, Multinational Study to Prevent Major Vascular Events With Ticagrelor Compared to Aspirin (ASA) in Patients With Acute Ischaemic Stroke or TIA.
The primary objective of the study is to compare the effect of 90-day treatment with ticagrelor (180 mg [two 90 mg tablets] loading dose on Day 1 followed by 90 mg twice daily maintenance dose for the remainder of the study) vs acetylsalicylic acid (ASA)-aspirin (300 mg [three 100 mg tablets] loading dose on Day 1 followed by 100 mg once daily maintenance dose for the remainder of the study) for the prevention of major vascular events (composite of stroke, myocardial infarction [MI], and death) in patients with acute ischaemic stroke or transient ischaemic attack (TIA).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
13307
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Buenos Aires, Argentina
- Research Site
-
Capital Federal, Argentina
- Research Site
-
Ciudad Autónoma de Bs. As., Argentina
- Research Site
-
Mar del Plata, Argentina
- Research Site
-
Rosario, Argentina
- Research Site
-
San Martin, Argentina
- Research Site
-
-
-
-
-
Adelaide, Australia
- Research Site
-
Bedford Park, Australia
- Research Site
-
Camperdown, Australia
- Research Site
-
Clayton, Australia
- Research Site
-
Darlinghurst, Australia
- Research Site
-
Footscray, Australia
- Research Site
-
Herston, Australia
- Research Site
-
New Lambton Heights, Australia
- Research Site
-
Parkville, Australia
- Research Site
-
Southport, Australia
- Research Site
-
Sydney, Australia
- Research Site
-
Woodville, Australia
- Research Site
-
-
-
-
-
Aalst, Belgium
- Research Site
-
Assebroek, Belgium
- Research Site
-
Brugge, Belgium
- Research Site
-
Brussels (Woluwé-St-Lambert), Belgium
- Research Site
-
Gent, Belgium
- Research Site
-
Godinne, Belgium
- Research Site
-
Leuven, Belgium
- Research Site
-
Liège, Belgium
- Research Site
-
Tielt, Belgium
- Research Site
-
Wilrijk, Belgium
- Research Site
-
-
-
-
-
Botucatu, Brazil
- Research Site
-
Curitiba, Brazil
- Research Site
-
Porto Alegre, Brazil
- Research Site
-
Ribeirao Preto, Brazil
- Research Site
-
Rio de Janeiro, Brazil
- Research Site
-
Salvador, Brazil
- Research Site
-
Sao Paulo, Brazil
- Research Site
-
São José do Rio Preto, Brazil
- Research Site
-
-
-
-
-
Botevgrad, Bulgaria
- Research Site
-
Dupnitsa, Bulgaria
- Research Site
-
Gotse Delchev, Bulgaria
- Research Site
-
Kozloduy, Bulgaria
- Research Site
-
Lukovit, Bulgaria
- Research Site
-
Pazardzhik, Bulgaria
- Research Site
-
Pernik, Bulgaria
- Research Site
-
Pleven, Bulgaria
- Research Site
-
Plovdiv, Bulgaria
- Research Site
-
Ruse, Bulgaria
- Research Site
-
Sandanski, Bulgaria
- Research Site
-
Sliven, Bulgaria
- Research Site
-
Sofia, Bulgaria
- Research Site
-
Teteven, Bulgaria
- Research Site
-
Yambol, Bulgaria
- Research Site
-
-
-
-
-
Quebec, Canada
- Research Site
-
-
Alberta
-
Calgary, Alberta, Canada
- Research Site
-
Edmonton, Alberta, Canada
- Research Site
-
-
British Columbia
-
Vancouver, British Columbia, Canada
- Research Site
-
-
Newfoundland and Labrador
-
St. John's, Newfoundland and Labrador, Canada
- Research Site
-
-
Ontario
-
London, Ontario, Canada
- Research Site
-
Ottawa, Ontario, Canada
- Research Site
-
Thunder Bay, Ontario, Canada
- Research Site
-
Toronto, Ontario, Canada
- Research Site
-
-
Quebec
-
Chicoutimi, Quebec, Canada
- Research Site
-
Greenfield Park, Quebec, Canada
- Research Site
-
Montreal, Quebec, Canada
- Research Site
-
-
-
-
-
Concepcion, Chile
- Research Site
-
Los Angeles, Chile
- Research Site
-
Santiago, Chile
- Research Site
-
Talcahuano, Chile
- Research Site
-
Temuco, Chile
- Research Site
-
Valdivia, Chile
- Research Site
-
Viña del Mar, Chile
- Research Site
-
-
-
-
-
Baotou, China
- Research Site
-
Beijing, China
- Research Site
-
Changchun, China
- Research Site
-
Changsha, China
- Research Site
-
Chongqin, China
- Research Site
-
Guang Zhou, China
- Research Site
-
Guangzhou, China
- Research Site
-
Guilin, China
- Research Site
-
Haikou, China
- Research Site
-
Hangzhou, China
- Research Site
-
Harbin, China
- Research Site
-
Huai'an, China
- Research Site
-
Jinan, China
- Research Site
-
Lanzhou, China
- Research Site
-
Linhai, China
- Research Site
-
Nanjing, China
- Research Site
-
Ningbo, China
- Research Site
-
Shanghai, China
- Research Site
-
Shenyang, China
- Research Site
-
Taiyuan, China
- Research Site
-
Tianjin, China
- Research Site
-
Wenzhou, China
- Research Site
-
Wu Han, China
- Research Site
-
Xi'an, China
- Research Site
-
Xiamen, China
- Research Site
-
Yangzhou, China
- Research Site
-
Zhanjiang, China
- Research Site
-
-
-
-
-
Brno, Czechia
- Research Site
-
Chomutov, Czechia
- Research Site
-
Hradec Kralove, Czechia
- Research Site
-
Jihlava, Czechia
- Research Site
-
Liberec, Czechia
- Research Site
-
Olomouc, Czechia
- Research Site
-
Ostrava, Czechia
- Research Site
-
Pardubice, Czechia
- Research Site
-
Praha 2, Czechia
- Research Site
-
Trutnov, Czechia
- Research Site
-
-
-
-
-
Antony, France
- Research Site
-
Bayonne, France
- Research Site
-
Bordeaux Cedex, France
- Research Site
-
Bourg en Bresse, France
- Research Site
-
Brest Cedex 2, France
- Research Site
-
Bron, France
- Research Site
-
Caen, France
- Research Site
-
Corbeil Essonnes Cedex, France
- Research Site
-
Creteil, France
- Research Site
-
Dijon, France
- Research Site
-
La Roche sur Yon, France
- Research Site
-
Le Chesnay Cedex, France
- Research Site
-
Le Coudray Cedex, France
- Research Site
-
Lille, France
- Research Site
-
NICE Cedex 01, France
- Research Site
-
PARIS Cedex 12, France
- Research Site
-
Paris, France
- Research Site
-
Paris Cedex 13, France
- Research Site
-
Paris Cedex 18, France
- Research Site
-
Pringy Cedex, France
- Research Site
-
Rennes, France
- Research Site
-
Rouen Cedex, France
- Research Site
-
Saint Herblain, France
- Research Site
-
Saint-priest En Jarez, France
- Research Site
-
Strasbourg Cedex, France
- Research Site
-
Toulouse, France
- Research Site
-
Tours, France
- Research Site
-
-
-
-
-
Altenburg, Germany
- Research Site
-
Bad Neustadt, Germany
- Research Site
-
Berlin, Germany
- Research Site
-
Erlangen, Germany
- Research Site
-
Essen, Germany
- Research Site
-
Frankfurt, Germany
- Research Site
-
Hamburg, Germany
- Research Site
-
Karlsruhe, Germany
- Research Site
-
Kassel, Germany
- Research Site
-
Minden, Germany
- Research Site
-
Münster, Germany
- Research Site
-
Osnabrück, Germany
- Research Site
-
Wiesbaden, Germany
- Research Site
-
-
-
-
-
Hong Kong, Hong Kong
- Research Site
-
Hongkong, Hong Kong
- Research Site
-
Kowloon, Hong Kong
- Research Site
-
Shatin, Hong Kong
- Research Site
-
-
-
-
-
Balassagyarmat, Hungary
- Research Site
-
Budapest, Hungary
- Research Site
-
Debrecen, Hungary
- Research Site
-
Győr, Hungary
- Research Site
-
Kistarcsa, Hungary
- Research Site
-
Miskolc, Hungary
- Research Site
-
Nagykanizsa, Hungary
- Research Site
-
Nyíregyháza, Hungary
- Research Site
-
Pécs, Hungary
- Research Site
-
Sopron-Balf, Hungary
- Research Site
-
Szekszárd, Hungary
- Research Site
-
Székesfehérvár, Hungary
- Research Site
-
-
-
-
-
Haifa, Israel
- Research Site
-
Holon, Israel
- Research Site
-
Jerusalem, Israel
- Research Site
-
Petach Tikva, Israel
- Research Site
-
Ramat Gan, Israel
- Research Site
-
Tel Aviv, Israel
- Research Site
-
-
-
-
-
Carrara, Italy
- Research Site
-
Citta' di Castello, Italy
- Research Site
-
Foligno, Italy
- Research Site
-
Genova, Italy
- Research Site
-
Gubbio, Italy
- Research Site
-
Lecco, Italy
- Research Site
-
Milano, Italy
- Research Site
-
Modena, Italy
- Research Site
-
Pavia, Italy
- Research Site
-
Perugia, Italy
- Research Site
-
Piacenza, Italy
- Research Site
-
Pisa, Italy
- Research Site
-
Reggio Emilia, Italy
- Research Site
-
Roma, Italy
- Research Site
-
Rozzano, Italy
- Research Site
-
Siena, Italy
- Research Site
-
Varese, Italy
- Research Site
-
Verona, Italy
- Research Site
-
Vibo Valentia, Italy
- Research Site
-
-
-
-
-
Aki-gun, Japan
- Research Site
-
Asahikawa-shi, Japan
- Research Site
-
Chiba-shi, Japan
- Research Site
-
Chikushi-gun, Japan
- Research Site
-
Chikushino-shi, Japan
- Research Site
-
Chitose-shi, Japan
- Research Site
-
Daito-shi, Japan
- Research Site
-
Date-gun, Japan
- Research Site
-
Eniwa-shi, Japan
- Research Site
-
Fujinomiya-shi, Japan
- Research Site
-
Fukui-shi, Japan
- Research Site
-
Fukuoka-shi, Japan
- Research Site
-
Fukushima-shi, Japan
- Research Site
-
Fukuyama-shi, Japan
- Research Site
-
Gifu-shi, Japan
- Research Site
-
Hachioji-shi, Japan
- Research Site
-
Hakodate-shi, Japan
- Research Site
-
Hamada-shi, Japan
- Research Site
-
Hanamaki-shi, Japan
- Research Site
-
Hatsukaichi-shi, Japan
- Research Site
-
Hidaka-shi, Japan
- Research Site
-
Higashiibaraki-gun, Japan
- Research Site
-
Higashiosaka-shi, Japan
- Research Site
-
Hitachi-shi, Japan
- Research Site
-
Ina-shi, Japan
- Research Site
-
Itami-shi, Japan
- Research Site
-
Izumisano-shi, Japan
- Research Site
-
Izumo-shi, Japan
- Research Site
-
Kaga-shi, Japan
- Research Site
-
Kagoshima-shi, Japan
- Research Site
-
Kakegawa-shi, Japan
- Research Site
-
Kamakura-shi, Japan
- Research Site
-
Kashiwazaki-shi, Japan
- Research Site
-
Kasuga-shi, Japan
- Research Site
-
Kawasaki-shi, Japan
- Research Site
-
Kobe-shi, Japan
- Research Site
-
Kochi-shi, Japan
- Research Site
-
Koga-shi, Japan
- Research Site
-
Komatsu-shi, Japan
- Research Site
-
Komoro-shi, Japan
- Research Site
-
Koshigaya-shi, Japan
- Research Site
-
Kumamoto-shi, Japan
- Research Site
-
Kure-shi, Japan
- Research Site
-
Kurume-shi, Japan
- Research Site
-
Kyoto-shi, Japan
- Research Site
-
Maizuru-shi, Japan
- Research Site
-
Marugame-shi, Japan
- Research Site
-
Matsudo-shi, Japan
- Research Site
-
Matsuyama-shi, Japan
- Research Site
-
Nagano-shi, Japan
- Research Site
-
Nagasaki-shi, Japan
- Research Site
-
Nagoya-shi, Japan
- Research Site
-
Nakano-ku, Japan
- Research Site
-
Nakano-shi, Japan
- Research Site
-
Narita-shi, Japan
- Research Site
-
Nihonmatsu-shi, Japan
- Research Site
-
Okayama-shi, Japan
- Research Site
-
Okinawa-shi, Japan
- Research Site
-
Onga-gun, Japan
- Research Site
-
Ookawa-shi, Japan
- Research Site
-
Osaka-shi, Japan
- Research Site
-
Saga-shi, Japan
- Research Site
-
Sagamihara-shi, Japan
- Research Site
-
Saijo-shi, Japan
- Research Site
-
Sakai-shi, Japan
- Research Site
-
Sanuki-shi, Japan
- Research Site
-
Sapporo-shi, Japan
- Research Site
-
Sayama-shi, Japan
- Research Site
-
Sendai-shi, Japan
- Research Site
-
Shiroishi-shi, Japan
- Research Site
-
Shizuoka-shi, Japan
- Research Site
-
Suita-shi, Japan
- Research Site
-
Suwa-shi, Japan
- Research Site
-
Tachikawa-shi, Japan
- Research Site
-
Takasaki-shi, Japan
- Research Site
-
Takayama-shi, Japan
- Research Site
-
Tokushima-shi, Japan
- Research Site
-
Toyama-shi, Japan
- Research Site
-
Toyohashi-shi, Japan
- Research Site
-
Toyota-shi, Japan
- Research Site
-
Tsu-shi, Japan
- Research Site
-
Ube-shi, Japan
- Research Site
-
Ueda-shi, Japan
- Research Site
-
Uji-shi, Japan
- Research Site
-
Ureshino-shi, Japan
- Research Site
-
Utsunomiya-shi, Japan
- Research Site
-
Yokohama-shi, Japan
- Research Site
-
Zentsuji-shi, Japan
- Research Site
-
-
-
-
-
Busan, Korea, Republic of
- Research Site
-
Daegu, Korea, Republic of
- Research Site
-
Gwangju, Korea, Republic of
- Research Site
-
Incheon, Korea, Republic of
- Research Site
-
Seongnam-si, Korea, Republic of
- Research Site
-
Seoul, Korea, Republic of
- Research Site
-
Wonju-si, Korea, Republic of
- Research Site
-
-
-
-
-
Aguascalientes, Mexico
- Research Site
-
Culiacan, Mexico
- Research Site
-
D.F, Mexico
- Research Site
-
Del. Cuauhtemoc, Mexico
- Research Site
-
Distrito Federal, Mexico
- Research Site
-
Monterrey, Mexico
- Research Site
-
-
-
-
-
Bellavista, Peru
- Research Site
-
Callao, Peru
- Research Site
-
Cusco, Peru
- Research Site
-
Lima, Peru
- Research Site
-
-
-
-
-
Baguio City, Philippines
- Research Site
-
Cagayan de Oro City, Philippines
- Research Site
-
Cebu, Philippines
- Research Site
-
Iloilo City, Philippines
- Research Site
-
Manila, Philippines
- Research Site
-
Pasay City, Philippines
- Research Site
-
Pasig City, Philippines
- Research Site
-
Quezon City, Philippines
- Research Site
-
-
-
-
-
Białystok, Poland
- Research Site
-
Chełm, Poland
- Research Site
-
Działdowo, Poland
- Research Site
-
Gdańsk, Poland
- Research Site
-
Gryfice, Poland
- Research Site
-
Katowice, Poland
- Research Site
-
Kielce, Poland
- Research Site
-
Końskie, Poland
- Research Site
-
Kraków, Poland
- Research Site
-
Lublin, Poland
- Research Site
-
Olsztyn, Poland
- Research Site
-
Ostrołęka, Poland
- Research Site
-
Sandomierz, Poland
- Research Site
-
Warszawa, Poland
- Research Site
-
Włocławek, Poland
- Research Site
-
Łódź, Poland
- Research Site
-
-
-
-
-
Bucharest, Romania
- Research Site
-
Iasi, Romania
- Research Site
-
Oradea, Romania
- Research Site
-
Sibiu, Romania
- Research Site
-
Timisoara, Romania
- Research Site
-
Tirgu-Mures, Romania
- Research Site
-
-
-
-
-
Belgorod, Russian Federation
- Research Site
-
Chelyabinsk, Russian Federation
- Research Site
-
Ekaterinburg, Russian Federation
- Research Site
-
Irkutsk, Russian Federation
- Research Site
-
Izhevsk, Russian Federation
- Research Site
-
Kazan, Russian Federation
- Research Site
-
Moscow, Russian Federation
- Research Site
-
Nizhnii Novgorod, Russian Federation
- Research Site
-
Nizhny Novgorod, Russian Federation
- Research Site
-
Novosibirsk, Russian Federation
- Research Site
-
Omsk, Russian Federation
- Research Site
-
Perm, Russian Federation
- Research Site
-
Saint Petersburg, Russian Federation
- Research Site
-
Saint-Petersburg, Russian Federation
- Research Site
-
Saratov, Russian Federation
- Research Site
-
Ufa, Russian Federation
- Research Site
-
Voronezh, Russian Federation
- Research Site
-
Yaroslavl, Russian Federation
- Research Site
-
-
-
-
-
Levoca, Slovakia
- Research Site
-
Martin, Slovakia
- Research Site
-
Nitra, Slovakia
- Research Site
-
Spisska Nova Ves, Slovakia
- Research Site
-
Trnava, Slovakia
- Research Site
-
Zilina, Slovakia
- Research Site
-
-
-
-
-
Albacete, Spain
- Research Site
-
Badalona(Barcelona), Spain
- Research Site
-
Barcelona, Spain
- Research Site
-
Gerona, Spain
- Research Site
-
Lleida, Spain
- Research Site
-
Madrid, Spain
- Research Site
-
Pamplona, Spain
- Research Site
-
Santiago(A Coruña), Spain
- Research Site
-
Sevilla, Spain
- Research Site
-
Valencia, Spain
- Research Site
-
Valladolid, Spain
- Research Site
-
-
-
-
-
Falun, Sweden
- Research Site
-
Göteborg, Sweden
- Research Site
-
Halmstad, Sweden
- Research Site
-
Karlstad, Sweden
- Research Site
-
Lidköping, Sweden
- Research Site
-
Linköping, Sweden
- Research Site
-
Malmö, Sweden
- Research Site
-
Mora, Sweden
- Research Site
-
Norrköping, Sweden
- Research Site
-
Stockholm, Sweden
- Research Site
-
Uppsala, Sweden
- Research Site
-
Västerås, Sweden
- Research Site
-
Östersund, Sweden
- Research Site
-
-
-
-
-
Aarau, Switzerland
- Research Site
-
Basel, Switzerland
- Research Site
-
Bern, Switzerland
- Research Site
-
Chur, Switzerland
- Research Site
-
Genève 14, Switzerland
- Research Site
-
Lausanne, Switzerland
- Research Site
-
Lugano, Switzerland
- Research Site
-
St. Gallen, Switzerland
- Research Site
-
Villars-sur-Glâne, Switzerland
- Research Site
-
Zürich, Switzerland
- Research Site
-
-
-
-
-
Changhua City, Taiwan
- Research Site
-
Chiayi, Taiwan
- Research Site
-
Kaohsiung, Taiwan
- Research Site
-
New Taipei, Taiwan
- Research Site
-
Taichung, Taiwan
- Research Site
-
Tainan, Taiwan
- Research Site
-
Taipei, Taiwan
- Research Site
-
Taoyuan Hsien, Taiwan
- Research Site
-
-
-
-
-
Bangkok, Thailand
- Research Site
-
Chonburi, Thailand
- Research Site
-
Khon Kaen, Thailand
- Research Site
-
Muang, Thailand
- Research Site
-
Patumthani, Thailand
- Research Site
-
Rajthevi, Thailand
- Research Site
-
Ratchathewi, Thailand
- Research Site
-
-
-
-
-
Ankara, Turkey
- Research Site
-
Antalya, Turkey
- Research Site
-
Eskisehir, Turkey
- Research Site
-
Istanbul, Turkey
- Research Site
-
Izmir, Turkey
- Research Site
-
Konya, Turkey
- Research Site
-
-
-
-
-
Ivano-Frankivsk, Ukraine
- Research Site
-
Kharkiv, Ukraine
- Research Site
-
Kyiv, Ukraine
- Research Site
-
Lutsk, Ukraine
- Research Site
-
Lviv, Ukraine
- Research Site
-
Uzhgorod, Ukraine
- Research Site
-
Vinnytsia, Ukraine
- Research Site
-
Zaporizhzhya, Ukraine
- Research Site
-
-
-
-
Alabama
-
Montgomery, Alabama, United States
- Research Site
-
-
Arizona
-
Phoenix, Arizona, United States
- Research Site
-
-
Arkansas
-
Fayetteville, Arkansas, United States
- Research Site
-
Fort Smith, Arkansas, United States
- Research Site
-
-
California
-
Fullerton, California, United States
- Research Site
-
Glendale, California, United States
- Research Site
-
Los Angeles, California, United States
- Research Site
-
Newport, California, United States
- Research Site
-
Oakland, California, United States
- Research Site
-
San Diego, California, United States
- Research Site
-
Stanford, California, United States
- Research Site
-
Torrance, California, United States
- Research Site
-
-
Colorado
-
Englewood, Colorado, United States
- Research Site
-
-
Florida
-
Altamonte Springs, Florida, United States
- Research Site
-
Aventura, Florida, United States
- Research Site
-
Boynton Beach, Florida, United States
- Research Site
-
Bradenton, Florida, United States
- Research Site
-
Gainesville, Florida, United States
- Research Site
-
Hialeah, Florida, United States
- Research Site
-
Jacksonville, Florida, United States
- Research Site
-
Lakeland, Florida, United States
- Research Site
-
Melbourne, Florida, United States
- Research Site
-
Pompano Beach, Florida, United States
- Research Site
-
Port Charlotte, Florida, United States
- Research Site
-
Sarasota, Florida, United States
- Research Site
-
Tampa, Florida, United States
- Research Site
-
West Palm Beach, Florida, United States
- Research Site
-
Weston, Florida, United States
- Research Site
-
-
Georgia
-
Columbus, Georgia, United States
- Research Site
-
-
Illinois
-
Chicago, Illinois, United States
- Research Site
-
Evanston, Illinois, United States
- Research Site
-
Glenview, Illinois, United States
- Research Site
-
Harvey, Illinois, United States
- Research Site
-
Joliet, Illinois, United States
- Research Site
-
Park Ridge, Illinois, United States
- Research Site
-
Springfield, Illinois, United States
- Research Site
-
Urbana, Illinois, United States
- Research Site
-
-
Indiana
-
Anderson, Indiana, United States
- Research Site
-
Fort Wayne, Indiana, United States
- Research Site
-
Muncie, Indiana, United States
- Research Site
-
-
Iowa
-
Des Moines, Iowa, United States
- Research Site
-
Iowa City, Iowa, United States
- Research Site
-
-
Louisiana
-
Alexandria, Louisiana, United States
- Research Site
-
New Orleans, Louisiana, United States
- Research Site
-
-
Maryland
-
Annapolis, Maryland, United States
- Research Site
-
Frederick, Maryland, United States
- Research Site
-
-
Massachusetts
-
Boston, Massachusetts, United States
- Research Site
-
-
Michigan
-
Detroit, Michigan, United States
- Research Site
-
Pontiac, Michigan, United States
- Research Site
-
Royal Oak, Michigan, United States
- Research Site
-
Southfield, Michigan, United States
- Research Site
-
West Bloomfield Township, Michigan, United States
- Research Site
-
-
Minnesota
-
Minneapolis, Minnesota, United States
- Research Site
-
Robbinsdale, Minnesota, United States
- Research Site
-
Saint Paul, Minnesota, United States
- Research Site
-
-
Missouri
-
Bridgeton, Missouri, United States
- Research Site
-
Columbia, Missouri, United States
- Research Site
-
Kansas City, Missouri, United States
- Research Site
-
Saint Louis, Missouri, United States
- Research Site
-
-
Montana
-
Great Falls, Montana, United States
- Research Site
-
Helena, Montana, United States
- Research Site
-
-
Nebraska
-
Omaha, Nebraska, United States
- Research Site
-
-
New Hampshire
-
Lebanon, New Hampshire, United States
- Research Site
-
-
New Jersey
-
Bayonne, New Jersey, United States
- Research Site
-
Edison, New Jersey, United States
- Research Site
-
Englewood, New Jersey, United States
- Research Site
-
Flemington, New Jersey, United States
- Research Site
-
New Brunswick, New Jersey, United States
- Research Site
-
Ridgewood, New Jersey, United States
- Research Site
-
West Orange, New Jersey, United States
- Research Site
-
-
New Mexico
-
Albuquerque, New Mexico, United States
- Research Site
-
-
New York
-
Brooklyn, New York, United States
- Research Site
-
Buffalo, New York, United States
- Research Site
-
New York, New York, United States
- Research Site
-
Stony Brook, New York, United States
- Research Site
-
Syracuse, New York, United States
- Research Site
-
The Bronx, New York, United States
- Research Site
-
-
North Carolina
-
Chapel Hill, North Carolina, United States
- Research Site
-
Charlotte, North Carolina, United States
- Research Site
-
Durham, North Carolina, United States
- Research Site
-
Greensboro, North Carolina, United States
- Research Site
-
Winston-Salem, North Carolina, United States
- Research Site
-
-
Ohio
-
Akron, Ohio, United States
- Research Site
-
Cleveland, Ohio, United States
- Research Site
-
Columbus, Ohio, United States
- Research Site
-
Maumee, Ohio, United States
- Research Site
-
Toledo, Ohio, United States
- Research Site
-
-
Oregon
-
Clackamas, Oregon, United States
- Research Site
-
Portland, Oregon, United States
- Research Site
-
-
Pennsylvania
-
Abington, Pennsylvania, United States
- Research Site
-
Allentown, Pennsylvania, United States
- Research Site
-
Doylestown, Pennsylvania, United States
- Research Site
-
Erie, Pennsylvania, United States
- Research Site
-
Hershey, Pennsylvania, United States
- Research Site
-
Philadelphia, Pennsylvania, United States
- Research Site
-
-
Rhode Island
-
Providence, Rhode Island, United States
- Research Site
-
-
South Carolina
-
Charleston, South Carolina, United States
- Research Site
-
Columbia, South Carolina, United States
- Research Site
-
-
South Dakota
-
Sioux Falls, South Dakota, United States
- Research Site
-
-
Tennessee
-
Chattanooga, Tennessee, United States
- Research Site
-
Knoxville, Tennessee, United States
- Research Site
-
Nashville, Tennessee, United States
- Research Site
-
-
Texas
-
Baytown, Texas, United States
- Research Site
-
Dallas, Texas, United States
- Research Site
-
El Paso, Texas, United States
- Research Site
-
Harlingen, Texas, United States
- Research Site
-
Houston, Texas, United States
- Research Site
-
Kingwood, Texas, United States
- Research Site
-
Southlake, Texas, United States
- Research Site
-
-
Virginia
-
Richmond, Virginia, United States
- Research Site
-
Roanoke, Virginia, United States
- Research Site
-
-
Washington
-
Seattle, Washington, United States
- Research Site
-
-
West Virginia
-
Huntington, West Virginia, United States
- Research Site
-
Morgantown, West Virginia, United States
- Research Site
-
-
Wisconsin
-
Milwaukee, Wisconsin, United States
- Research Site
-
-
-
-
-
Hanoi, Vietnam
- Research Site
-
Ho Chi Minh City, Vietnam
- Research Site
-
Hochiminh, Vietnam
- Research Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
40 years to 130 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Men or women equal or elder 40 years of age
- Either acute ischaemic stroke or high-risk TIA as defined here and randomisation occurring within 24 hours after onset of symptoms
Key Exclusion Criteria:
- Planned use of antithrombotic therapy in addition to study medication including antiplatelets (eg, open label ASA, GPIIb/IIIa inhibitors, clopidogrel, ticlopidine, prasugrel, dipyridamole, ozagrel, cilostazol) and anticoagulants (eg, warfarin, oral thrombin and factor Xa inhibitors, bivalirudin, hirudin, argatroban, unfractionated and low molecular weight heparins). - Any history of atrial fibrillation, ventricular aneurysm or suspicion of cardioembolic pathology for TIA or stroke. - Planned carotid, cerebrovascular, or coronary revascularisation that requires halting study medication within 7 days of randomisation. - Receipt of any intravenous or intra-arterial thrombolysis or mechanical thrombectomy within 24 hours prior to randomisation - History of previous symptomatic non-traumatic intracerebral bleed at any time (asymptomatic microbleeds do not qualify), gastrointestinal (GI) bleed within the past 6 months, or major surgery within 30 days.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: ticagrelor
|
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
|
|
Active Comparator: Acetylsalicylic acid (ASA)
|
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Composite of Stroke/MI/Death
Time Frame: From randomization up to 97 days
|
Participants with stroke, MI or death.
If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
|
From randomization up to 97 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of Participants With Ischaemic Stroke
Time Frame: From randomization up to 97 days
|
Participants with ischaemic stroke.
If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Net Clinical Outcome
Time Frame: From randomization up to 97 days
|
Participants with stroke, MI, death or life-threatening bleeding.
If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
Time Frame: From randomization up to 97 days
|
Participants with ischaemic stroke, MI or CV death.
If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Number of Participants With All-Cause Death
Time Frame: From randomization up to 97 days
|
Participants with all-cause death.
If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Number of Participants With CV Death
Time Frame: From randomization up to 97 days
|
Participants with CV death.
If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Number of Participants With MI
Time Frame: From randomization up to 97 days
|
Participants with MI.
If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
|
From randomization up to 97 days
|
|
Number of Participants by Severity of Stroke and Overall Disability
Time Frame: From randomization up to 97 days
|
Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS. Modified Rankin Score: 0 - No symptoms.
Disability defined as mRS > 1. Odds ratio and p-value are calculated for ticagrelor versus ASA from a logistic regression model with treatment group, history of stroke and NIHSS (National Institutes of Health Stroke Scale) at baseline as explanatory variables. |
From randomization up to 97 days
|
|
Number of Participants With Stroke
Time Frame: From randomization up to 97 days
|
Participants with stroke.
If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)
|
From randomization up to 97 days
|
|
Number of Participants With Fatal Stroke
Time Frame: From randomization up to 97 days
|
Participants with fatal stroke.
If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Number of Participants With Disabling Stroke
Time Frame: From randomization up to 97 days
|
Participants with disabling stroke.
If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
|
From randomization up to 97 days
|
|
Change in NIHSS
Time Frame: From randomization up to 97 days
|
Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale): 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke. |
From randomization up to 97 days
|
|
EQ-5D at Visit 1 (Enrolment)
Time Frame: Visit 1 (Enrolment)
|
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
Visit 1 (Enrolment)
|
|
EQ-5D at Visit 2 (Day 7+-2d)
Time Frame: Visit 2 (Day 7+-2d)
|
EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
Visit 2 (Day 7+-2d)
|
|
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
Time Frame: End of treatment visit (Day 90+-7d)
|
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
End of treatment visit (Day 90+-7d)
|
|
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
Time Frame: Premature treatment discontinuation visit(<15 days after last dose)
|
EQ-5D index score using the UK tariff. EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples. The higher the index score the better the health state. In this study index scores ran from -0.59 to 1. |
Premature treatment discontinuation visit(<15 days after last dose)
|
|
Number of Participants With PLATO Major Bleeding Event
Time Frame: From randomization up to 97 days
|
Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97). PLATO Major bleeding is defined as a bleed that is any one of:
|
From randomization up to 97 days
|
|
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
Time Frame: Time from first dose and up to and including 7 days following the date of last dose of the study
|
Participants discontinuation of study drug due to any bleeding adverse event.
If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).
|
Time from first dose and up to and including 7 days following the date of last dose of the study
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Diener HC, Easton JD, Hart RG, Kasner S, Kamel H, Ntaios G. Review and update of the concept of embolic stroke of undetermined source. Nat Rev Neurol. 2022 Aug;18(8):455-465. doi: 10.1038/s41582-022-00663-4. Epub 2022 May 10.
- Evans SR, Knutsson M, Amarenco P, Albers GW, Bath PM, Denison H, Ladenvall P, Jonasson J, Easton JD, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC. Methodologies for pragmatic and efficient assessment of benefits and harms: Application to the SOCRATES trial. Clin Trials. 2020 Dec;17(6):617-626. doi: 10.1177/1740774520941441. Epub 2020 Jul 15.
- Cucchiara B, George DK, Kasner SE, Knutsson M, Denison H, Ladenvall P, Amarenco P, Johnston SC. Disability after minor stroke and TIA: A secondary analysis of the SOCRATES trial. Neurology. 2019 Aug 13;93(7):e708-e716. doi: 10.1212/WNL.0000000000007936. Epub 2019 Jul 11.
- Easton JD, Denison H, Evans SR, Knutsson M, Amarenco P, Albers GW, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KL, Johnston SC; SOCRATES Steering Committee and Investigators. Estimated treatment effect of ticagrelor versus aspirin by investigator-assessed events compared with judgement by an independent event adjudication committee in the SOCRATES trial. Int J Stroke. 2019 Dec;14(9):908-914. doi: 10.1177/1747493019851282. Epub 2019 May 15.
- Molina CA, Johnston SC, Ladenvall P, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Knutsson M, Minematsu K, Rother J, Wang Y, Wong KSL; SOCRATES Steering Committee and Investigators. Time to Loading Dose and Risk of Recurrent Events in the SOCRATES Trial. Stroke. 2019 Mar;50(3):675-682. doi: 10.1161/STROKEAHA.118.022675. Erratum In: Stroke. 2019 Apr;50(4):e118.
- Wong KSL, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Himmelmann A, Kasner SE, Knutsson M, Ladenvall P, Minematsu K, Molina CA, Wang Y, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and Safety of Ticagrelor in Relation to Aspirin Use Within the Week Before Randomization in the SOCRATES Trial. Stroke. 2018 Jul;49(7):1678-1685. doi: 10.1161/STROKEAHA.118.020553. Epub 2018 Jun 18.
- Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor Versus Aspirin in Acute Embolic Stroke of Undetermined Source. Stroke. 2017 Sep;48(9):2480-2487. doi: 10.1161/STROKEAHA.117.017217. Epub 2017 Jul 18.
- Easton JD, Aunes M, Albers GW, Amarenco P, Bokelund-Singh S, Denison H, Evans SR, Held P, Jahreskog M, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Risk for Major Bleeding in Patients Receiving Ticagrelor Compared With Aspirin After Transient Ischemic Attack or Acute Ischemic Stroke in the SOCRATES Study (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Circulation. 2017 Sep 5;136(10):907-916. doi: 10.1161/CIRCULATIONAHA.117.028566. Epub 2017 Jun 27.
- Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Hill MD, Jonasson J, Kasner SE, Ladenvall P, Minematsu K, Molina CA, Wang Y, Wong KSL, Johnston SC; SOCRATES Steering Committee and Investigators. Efficacy and safety of ticagrelor versus aspirin in acute stroke or transient ischaemic attack of atherosclerotic origin: a subgroup analysis of SOCRATES, a randomised, double-blind, controlled trial. Lancet Neurol. 2017 Apr;16(4):301-310. doi: 10.1016/S1474-4422(17)30038-8. Epub 2017 Feb 23.
- Wang Y, Minematsu K, Wong KS, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Molina CA, Johnston SC; SOCRATES Steering Committee and Investigators. Ticagrelor in Acute Stroke or Transient Ischemic Attack in Asian Patients: From the SOCRATES Trial (Acute Stroke or Transient Ischemic Attack Treated With Aspirin or Ticagrelor and Patient Outcomes). Stroke. 2017 Jan;48(1):167-173. doi: 10.1161/STROKEAHA.116.014891. Epub 2016 Nov 29.
- Held P, Himmelmann A, Ditmarsch M. Ticagrelor for the treatment of atherosclerotic disease: insights from the PARTHENON clinical development program. Future Cardiol. 2016 Jul;12(4):405-18. doi: 10.2217/fca-2016-0028. Epub 2016 May 10.
- Johnston SC, Amarenco P, Albers GW, Denison H, Easton JD, Evans SR, Held P, Jonasson J, Minematsu K, Molina CA, Wang Y, Wong KS; SOCRATES Steering Committee and Investigators. Ticagrelor versus Aspirin in Acute Stroke or Transient Ischemic Attack. N Engl J Med. 2016 Jul 7;375(1):35-43. doi: 10.1056/NEJMoa1603060. Epub 2016 May 10.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2014
Primary Completion (Actual)
March 2, 2016
Study Completion (Actual)
March 2, 2016
Study Registration Dates
First Submitted
November 18, 2013
First Submitted That Met QC Criteria
November 25, 2013
First Posted (Estimate)
November 26, 2013
Study Record Updates
Last Update Posted (Actual)
June 12, 2017
Last Update Submitted That Met QC Criteria
May 12, 2017
Last Verified
May 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Cerebrovascular Disorders
- Brain Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Brain Ischemia
- Stroke
- Ischemic Stroke
- Ischemia
- Ischemic Attack, Transient
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Fibrinolytic Agents
- Fibrin Modulating Agents
- Platelet Aggregation Inhibitors
- Cyclooxygenase Inhibitors
- Antipyretics
- Purinergic P2Y Receptor Antagonists
- Purinergic P2 Receptor Antagonists
- Purinergic Antagonists
- Purinergic Agents
- Aspirin
- Ticagrelor
Other Study ID Numbers
- D5134C00001
- 2012-003895-38 (EudraCT Number)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Acute Ischaemic Stroke
-
Capital Medical UniversityCompletedAcute Ischaemic Stroke | Stroke-associated PneumoniaChina
-
Beijing Tiantan HospitalCentral Hospital of Dalian University of TechnologyNot yet recruitingPrognosis | Acute Ischaemic Stroke | Endovascular Therapy | Blood Pressure Management | Collateral CirculationChina
-
EIP Pharma IncCervoMed, IncRecruitingIschaemic Stroke | Moderate to Severe Acute Ischaemic StrokeAustralia
-
Institut National de la Santé Et de la Recherche...Fondation de l'AvenirCompleted
-
NHS Greater Glasgow and ClydeUniversity of Glasgow; Aurum Biosciences LtdUnknown
-
AstraZenecaCompletedAcute Ischaemic Stroke | Transient Ischaemic AttackBelgium, France, Italy, Spain, Sweden, Thailand, Germany, Korea, Republic of, Brazil, Hungary, India, Mexico, Vietnam, China, Taiwan, Hong Kong, Slovakia, Australia, Poland, Saudi Arabia, Ukraine, Canada, Russian Federation, Bulgaria, R... and more
-
Istanbul Aydın UniversityEnrolling by invitationStroke | Ischaemic StrokeTurkey (Türkiye)
-
Zhujiang HospitalRecruitingDepression | Acute Ischaemic StrokeChina
-
Firstkind LtdInnovate UKRecruiting
-
Auckland City HospitalHealth New Zealand; Neurological Foundation of New ZealandNot yet recruitingStroke | Brain Ischemia | Reperfusion Injury | Acute Ischemic Stroke | Large Vessel Occlusion | Endovascular Procedures | Thrombectomy | Ischaemic Stroke | CoolingNew Zealand
Clinical Trials on ticagrelor
-
Collegium Medicum w BydgoszczyCompleted
-
University of FloridaCompleted
-
Federico II UniversityAdvicePharma GroupCompletedMyocardial Infarction | Coronary Artery Disease | Acute Coronary Syndrome | STEMI | NSTEMIItaly
-
AstraZenecaParexelCompletedSickle Cell DiseaseGermany
-
University of FloridaAstraZenecaCompleted
-
David AntoniucciAstraZeneca; A.R. CARD Onlus FoundationCompletedAcute Coronary Syndrome | Adverse Reaction to Antiplatelet AgentItaly, Greece
-
Centro Hospitalario La ConcepcionRecruiting
-
Sheba Medical CenterCompletedST Elevation Myocardial Infarction | Acute Coronary SyndromesIsrael
-
Montreal Heart InstituteRecruitingMyocardial Infarction | NSTEMI - Non-ST Segment Elevation MI | STEMI (ST Elevation MI)Canada
-
Cairo UniversityCompletedCardiovascular Diseases | Acute Coronary SyndromeEgypt