NCT01994720

Brief Summary

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).

Trial Health

98
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Strong global presence with extensive site network
Enrollment
13,307

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2014

Geographic Reach
33 countries

521 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2013

Completed
8 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

January 7, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 2, 2016

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

May 1, 2017

Enrollment Period

2.2 years

First QC Date

November 18, 2013

Results QC Date

March 7, 2017

Last Update Submit

May 12, 2017

Conditions

Keywords

Acute ischaemic stroke.Transient ischaemic attack.

Outcome Measures

Primary Outcomes (1)

  • Number of Participants With Composite of Stroke/MI/Death

    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 Outcomes (17)

  • Number of Participants With Ischaemic Stroke

    From randomization up to 97 days

  • Net Clinical Outcome

    From randomization up to 97 days

  • Number of Participants With Composite of Ischaemic Stroke, MI and CV Death

    From randomization up to 97 days

  • Number of Participants With All-Cause Death

    From randomization up to 97 days

  • Number of Participants With CV Death

    From randomization up to 97 days

  • +12 more secondary outcomes

Study Arms (2)

ticagrelor

EXPERIMENTAL
Drug: ticagrelor

Acetylsalicylic acid (ASA)

ACTIVE COMPARATOR
Drug: Acetylsalicylic acid (ASA)

Interventions

ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.

ticagrelor

ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Acetylsalicylic acid (ASA)

Eligibility Criteria

Age40 Years - 130 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (521)

Research Site

Montgomery, Alabama, United States

Location

Research Site

Phoenix, Arizona, United States

Location

Research Site

Fayetteville, Arkansas, United States

Location

Research Site

Fort Smith, Arkansas, United States

Location

Research Site

Fullerton, California, United States

Location

Research Site

Glendale, California, United States

Location

Research Site

Los Angeles, California, United States

Location

Research Site

Newport, California, United States

Location

Research Site

Oakland, California, United States

Location

Research Site

San Diego, California, United States

Location

Research Site

Stanford, California, United States

Location

Research Site

Torrance, California, United States

Location

Research Site

Englewood, Colorado, United States

Location

Research Site

Altamonte Springs, Florida, United States

Location

Research Site

Aventura, Florida, United States

Location

Research Site

Boynton Beach, Florida, United States

Location

Research Site

Bradenton, Florida, United States

Location

Research Site

Gainesville, Florida, United States

Location

Research Site

Hialeah, Florida, United States

Location

Research Site

Jacksonville, Florida, United States

Location

Research Site

Lakeland, Florida, United States

Location

Research Site

Melbourne, Florida, United States

Location

Research Site

Pompano Beach, Florida, United States

Location

Research Site

Port Charlotte, Florida, United States

Location

Research Site

Sarasota, Florida, United States

Location

Research Site

Tampa, Florida, United States

Location

Research Site

West Palm Beach, Florida, United States

Location

Research Site

Weston, Florida, United States

Location

Research Site

Columbus, Georgia, United States

Location

Research Site

Chicago, Illinois, United States

Location

Research Site

Evanston, Illinois, United States

Location

Research Site

Glenview, Illinois, United States

Location

Research Site

Harvey, Illinois, United States

Location

Research Site

Joliet, Illinois, United States

Location

Research Site

Park Ridge, Illinois, United States

Location

Research Site

Springfield, Illinois, United States

Location

Research Site

Urbana, Illinois, United States

Location

Research Site

Anderson, Indiana, United States

Location

Research Site

Fort Wayne, Indiana, United States

Location

Research Site

Muncie, Indiana, United States

Location

Research Site

Des Moines, Iowa, United States

Location

Research Site

Iowa City, Iowa, United States

Location

Research Site

Alexandria, Louisiana, United States

Location

Research Site

New Orleans, Louisiana, United States

Location

Research Site

Annapolis, Maryland, United States

Location

Research Site

Frederick, Maryland, United States

Location

Research Site

Boston, Massachusetts, United States

Location

Research Site

Detroit, Michigan, United States

Location

Research Site

Pontiac, Michigan, United States

Location

Research Site

Royal Oak, Michigan, United States

Location

Research Site

Southfield, Michigan, United States

Location

Research Site

West Bloomfield, Michigan, United States

Location

Research Site

Minneapolis, Minnesota, United States

Location

Research Site

Robbinsdale, Minnesota, United States

Location

Research Site

Saint Paul, Minnesota, United States

Location

Research Site

Bridgeton, Missouri, United States

Location

Research Site

Columbia, Missouri, United States

Location

Research Site

Kansas City, Missouri, United States

Location

Research Site

St Louis, Missouri, United States

Location

Research Site

Great Falls, Montana, United States

Location

Research Site

Helena, Montana, United States

Location

Research Site

Omaha, Nebraska, United States

Location

Research Site

Lebanon, New Hampshire, United States

Location

Research Site

Bayonne, New Jersey, United States

Location

Research Site

Edison, New Jersey, United States

Location

Research Site

Englewood, New Jersey, United States

Location

Research Site

Flemington, New Jersey, United States

Location

Research Site

New Brunswick, New Jersey, United States

Location

Research Site

Ridgewood, New Jersey, United States

Location

Research Site

West Orange, New Jersey, United States

Location

Research Site

Albuquerque, New Mexico, United States

Location

Research Site

Brooklyn, New York, United States

Location

Research Site

Buffalo, New York, United States

Location

Research Site

New York, New York, United States

Location

Research Site

Stony Brook, New York, United States

Location

Research Site

Syracuse, New York, United States

Location

Research Site

The Bronx, New York, United States

Location

Research Site

Chapel Hill, North Carolina, United States

Location

Research Site

Charlotte, North Carolina, United States

Location

Research Site

Durham, North Carolina, United States

Location

Research Site

Greensboro, North Carolina, United States

Location

Research Site

Winston-Salem, North Carolina, United States

Location

Research Site

Akron, Ohio, United States

Location

Research Site

Cleveland, Ohio, United States

Location

Research Site

Columbus, Ohio, United States

Location

Research Site

Maumee, Ohio, United States

Location

Research Site

Toledo, Ohio, United States

Location

Research Site

Clackamas, Oregon, United States

Location

Research Site

Portland, Oregon, United States

Location

Research Site

Abington, Pennsylvania, United States

Location

Research Site

Allentown, Pennsylvania, United States

Location

Research Site

Doylestown, Pennsylvania, United States

Location

Research Site

Erie, Pennsylvania, United States

Location

Research Site

Hershey, Pennsylvania, United States

Location

Research Site

Philadelphia, Pennsylvania, United States

Location

Research Site

Providence, Rhode Island, United States

Location

Research Site

Charleston, South Carolina, United States

Location

Research Site

Columbia, South Carolina, United States

Location

Research Site

Sioux Falls, South Dakota, United States

Location

Research Site

Chattanooga, Tennessee, United States

Location

Research Site

Knoxville, Tennessee, United States

Location

Research Site

Nashville, Tennessee, United States

Location

Research Site

Baytown, Texas, United States

Location

Research Site

Dallas, Texas, United States

Location

Research Site

El Paso, Texas, United States

Location

Research Site

Harlingen, Texas, United States

Location

Research Site

Houston, Texas, United States

Location

Research Site

Kingwood, Texas, United States

Location

Research Site

Southlake, Texas, United States

Location

Research Site

Richmond, Virginia, United States

Location

Research Site

Roanoke, Virginia, United States

Location

Research Site

Seattle, Washington, United States

Location

Research Site

Huntington, West Virginia, United States

Location

Research Site

Morgantown, West Virginia, United States

Location

Research Site

Milwaukee, Wisconsin, United States

Location

Research Site

Buenos Aires, Argentina

Location

Research Site

Capital Federal, Argentina

Location

Research Site

Ciudad Autónoma de Bs. As., Argentina

Location

Research Site

Mar del Plata, Argentina

Location

Research Site

Rosario, Argentina

Location

Research Site

San Martín, Argentina

Location

Research Site

Adelaide, Australia

Location

Research Site

Bedford Park, Australia

Location

Research Site

Camperdown, Australia

Location

Research Site

Clayton, Australia

Location

Research Site

Darlinghurst, Australia

Location

Research Site

Footscray, Australia

Location

Research Site

Herston, Australia

Location

Research Site

New Lambton Heights, Australia

Location

Research Site

Parkville, Australia

Location

Research Site

Southport, Australia

Location

Research Site

Sydney, Australia

Location

Research Site

Woodville, Australia

Location

Research Site

Aalst, Belgium

Location

Research Site

Assebroek, Belgium

Location

Research Site

Bruges, Belgium

Location

Research Site

Brussels (Woluwé-St-Lambert), Belgium

Location

Research Site

Ghent, Belgium

Location

Research Site

Godinne, Belgium

Location

Research Site

Leuven, Belgium

Location

Research Site

Liège, Belgium

Location

Research Site

Tielt, Belgium

Location

Research Site

Wilrijk, Belgium

Location

Research Site

Botucatu, Brazil

Location

Research Site

Curitiba, Brazil

Location

Research Site

Porto Alegre, Brazil

Location

Research Site

Ribeirão Preto, Brazil

Location

Research Site

Rio de Janeiro, Brazil

Location

Research Site

Salvador, Brazil

Location

Research Site

São José do Rio Preto, Brazil

Location

Research Site

São Paulo, Brazil

Location

Research Site

Botevgrad, Bulgaria

Location

Research Site

Dupnitsa, Bulgaria

Location

Research Site

Gotse Delchev, Bulgaria

Location

Research Site

Kozloduy, Bulgaria

Location

Research Site

Lukovit, Bulgaria

Location

Research Site

Pazardzhik, Bulgaria

Location

Research Site

Pernik, Bulgaria

Location

Research Site

Pleven, Bulgaria

Location

Research Site

Plovdiv, Bulgaria

Location

Research Site

Rousse, Bulgaria

Location

Research Site

Sandanski, Bulgaria

Location

Research Site

Sliven, Bulgaria

Location

Research Site

Sofia, Bulgaria

Location

Research Site

Teteven, Bulgaria

Location

Research Site

Yambol, Bulgaria

Location

Research Site

Calgary, Alberta, Canada

Location

Research Site

Edmonton, Alberta, Canada

Location

Research Site

Vancouver, British Columbia, Canada

Location

Research Site

St. John's, Newfoundland and Labrador, Canada

Location

Research Site

London, Ontario, Canada

Location

Research Site

Ottawa, Ontario, Canada

Location

Research Site

Thunder Bay, Ontario, Canada

Location

Research Site

Toronto, Ontario, Canada

Location

Research Site

Chicoutimi, Quebec, Canada

Location

Research Site

Greenfield Park, Quebec, Canada

Location

Research Site

Montreal, Quebec, Canada

Location

Research Site

Québec, Quebec, Canada

Location

Research Site

Concepción, Chile

Location

Research Site

Los Ángeles, Chile

Location

Research Site

Santiago, Chile

Location

Research Site

Talcahuano, Chile

Location

Research Site

Temuco, Chile

Location

Research Site

Valdivia, Chile

Location

Research Site

Viña del Mar, Chile

Location

Research Site

Baotou, China

Location

Research Site

Beijing, China

Location

Research Site

Changchun, China

Location

Research Site

Changsha, China

Location

Research Site

Chongqin, China

Location

Research Site

Guangzhou, China

Location

Research Site

Guilin, China

Location

Research Site

Haikou, China

Location

Research Site

Hangzhou, China

Location

Research Site

Harbin, China

Location

Research Site

Huai'an, China

Location

Research Site

Jinan, China

Location

Research Site

Lanzhou, China

Location

Research Site

Linhai, China

Location

Research Site

Nanjing, China

Location

Research Site

Ningbo, China

Location

Research Site

Shanghai, China

Location

Research Site

Shenyang, China

Location

Research Site

Taiyuan, China

Location

Research Site

Tianjin, China

Location

Research Site

Wenzhou, China

Location

Research Site

Wuhan, China

Location

Research Site

Xi'an, China

Location

Research Site

Xiamen, China

Location

Research Site

Yangzhou, China

Location

Research Site

Zhanjiang, China

Location

Research Site

Brno, Czechia

Location

Research Site

Chomutov, Czechia

Location

Research Site

Hradec Králové, Czechia

Location

Research Site

Jihlava, Czechia

Location

Research Site

Liberec, Czechia

Location

Research Site

Olomouc, Czechia

Location

Research Site

Ostrava, Czechia

Location

Research Site

Pardubice, Czechia

Location

Research Site

Prague, Czechia

Location

Research Site

Trutnov, Czechia

Location

Research Site

Antony, France

Location

Research Site

Bayonne, France

Location

Research Site

Bordeaux, France

Location

Research Site

Bourg-en-Bresse, France

Location

Research Site

Brest, France

Location

Research Site

Bron, France

Location

Research Site

Caen, France

Location

Research Site

Corbeil-Essonnes, France

Location

Research Site

Créteil, France

Location

Research Site

Dijon, France

Location

Research Site

La Roche-sur-Yon, France

Location

Research Site

Le Chesnay, France

Location

Research Site

Le Coudray, France

Location

Research Site

Lille, France

Location

Research Site

Nice, France

Location

Research Site

Paris, France

Location

Research Site

Pringy, France

Location

Research Site

Rennes, France

Location

Research Site

Rouen, France

Location

Research Site

Saint-Herblain, France

Location

Research Site

Saint-Priest-en-Jarez, France

Location

Research Site

Strasbourg, France

Location

Research Site

Toulouse, France

Location

Research Site

Tours, France

Location

Research Site

Altenburg, Germany

Location

Research Site

Bad Neustadt an der Saale, Germany

Location

Research Site

Berlin, Germany

Location

Research Site

Erlangen, Germany

Location

Research Site

Essen, Germany

Location

Research Site

Frankfurt, Germany

Location

Research Site

Hamburg, Germany

Location

Research Site

Karlsruhe, Germany

Location

Research Site

Kassel, Germany

Location

Research Site

Minden, Germany

Location

Research Site

Münster, Germany

Location

Research Site

Osnabrück, Germany

Location

Research Site

Wiesbaden, Germany

Location

Research Site

Hong Kong, Hong Kong

Location

Research Site

Kowloon, Hong Kong

Location

Research Site

Shatin, Hong Kong

Location

Research Site

Balassagyarmat, Hungary

Location

Research Site

Budapest, Hungary

Location

Research Site

Debrecen, Hungary

Location

Research Site

Győr, Hungary

Location

Research Site

Kistarcsa, Hungary

Location

Research Site

Miskolc, Hungary

Location

Research Site

Nagykanizsa, Hungary

Location

Research Site

Nyíregyháza, Hungary

Location

Research Site

Pécs, Hungary

Location

Research Site

Sopron-Balf, Hungary

Location

Research Site

Szekszárd, Hungary

Location

Research Site

Székesfehérvár, Hungary

Location

Research Site

Haifa, Israel

Location

Research Site

Holon, Israel

Location

Research Site

Jerusalem, Israel

Location

Research Site

Petah Tikva, Israel

Location

Research Site

Ramat Gan, Israel

Location

Research Site

Tel Aviv, Israel

Location

Research Site

Carrara, Italy

Location

Research Site

Città di Castello, Italy

Location

Research Site

Foligno, Italy

Location

Research Site

Genova, Italy

Location

Research Site

Gubbio, Italy

Location

Research Site

Lecco, Italy

Location

Research Site

Milan, Italy

Location

Research Site

Modena, Italy

Location

Research Site

Pavia, Italy

Location

Research Site

Perugia, Italy

Location

Research Site

Piacenza, Italy

Location

Research Site

Pisa, Italy

Location

Research Site

Reggio Emilia, Italy

Location

Research Site

Roma, Italy

Location

Research Site

Rozzano, Italy

Location

Research Site

Siena, Italy

Location

Research Site

Varese, Italy

Location

Research Site

Verona, Italy

Location

Research Site

Vibo Valentia, Italy

Location

Research Site

Aki-gun, Japan

Location

Research Site

Asahikawa-shi, Japan

Location

Research Site

Chiba, Japan

Location

Research Site

Chikushi-gun, Japan

Location

Research Site

Chikushino-shi, Japan

Location

Research Site

Chitose-shi, Japan

Location

Research Site

Daito-shi, Japan

Location

Research Site

Date-gun, Japan

Location

Research Site

Eniwa-shi, Japan

Location

Research Site

Fujinomiya-shi, Japan

Location

Research Site

Fukui-shi, Japan

Location

Research Site

Fukuoka, Japan

Location

Research Site

Fukushima, Japan

Location

Research Site

Fukuyama-shi, Japan

Location

Research Site

Gifu, Japan

Location

Research Site

Hachioji-shi, Japan

Location

Research Site

Hakodate-shi, Japan

Location

Research Site

Hamada-shi, Japan

Location

Research Site

Hanamaki-shi, Japan

Location

Research Site

Hatsukaichi-shi, Japan

Location

Research Site

Hidaka-shi, Japan

Location

Research Site

Higashiibaraki-gun, Japan

Location

Research Site

Higashiosaka-shi, Japan

Location

Research Site

Hitachi-shi, Japan

Location

Research Site

Ina-shi, Japan

Location

Research Site

Itami-shi, Japan

Location

Research Site

Izumisano, Japan

Location

Research Site

Izumo-shi, Japan

Location

Research Site

Kaga-shi, Japan

Location

Research Site

Kagoshima, Japan

Location

Research Site

Kakegawa-shi, Japan

Location

Research Site

Kamakura-shi, Japan

Location

Research Site

Kashiwazaki-shi, Japan

Location

Research Site

Kasuga-shi, Japan

Location

Research Site

Kawasaki-shi, Japan

Location

Research Site

Kobe, Japan

Location

Research Site

Kochi, Japan

Location

Research Site

Koga-shi, Japan

Location

Research Site

Komatsu-shi, Japan

Location

Research Site

Komoro-shi, Japan

Location

Research Site

Koshigaya-shi, Japan

Location

Research Site

Kumamoto, Japan

Location

Research Site

Kure-shi, Japan

Location

Research Site

Kurume-shi, Japan

Location

Research Site

Kyoto, Japan

Location

Research Site

Maizuru-shi, Japan

Location

Research Site

Marugame-shi, Japan

Location

Research Site

Matsudo-shi, Japan

Location

Research Site

Matsuyama, Japan

Location

Research Site

Nagano, Japan

Location

Research Site

Nagasaki, Japan

Location

Research Site

Nagoya, Japan

Location

Research Site

Nakano, Japan

Location

Research Site

Nakano-shi, Japan

Location

Research Site

Narita-shi, Japan

Location

Research Site

Nihonmatsu-shi, Japan

Location

Research Site

Okayama, Japan

Location

Research Site

Okinawa-shi, Japan

Location

Research Site

Onga-gun, Japan

Location

Research Site

Ookawa-shi, Japan

Location

Research Site

Osaka, Japan

Location

Research Site

Saga, Japan

Location

Research Site

Sagamihara-shi, Japan

Location

Research Site

Saijo-shi, Japan

Location

Research Site

Sakaishi, Japan

Location

Research Site

Sanuki-shi, Japan

Location

Research Site

Sapporo, Japan

Location

Research Site

Sayama-shi, Japan

Location

Research Site

Sendai, Japan

Location

Research Site

Shiroishi-shi, Japan

Location

Research Site

Shizuoka, Japan

Location

Research Site

Suita-shi, Japan

Location

Research Site

Suwa-shi, Japan

Location

Research Site

Tachikawa-shi, Japan

Location

Research Site

Takasaki-shi, Japan

Location

Research Site

Takayama-shi, Japan

Location

Research Site

Tokushima, Japan

Location

Research Site

Toyama, Japan

Location

Research Site

Toyohashi, Japan

Location

Research Site

Toyota-shi, Japan

Location

Research Site

Tsu, Japan

Location

Research Site

Ube-shi, Japan

Location

Research Site

Ueda-shi, Japan

Location

Research Site

Uji-shi, Japan

Location

Research Site

Ureshino-shi, Japan

Location

Research Site

Utsunomiya, Japan

Location

Research Site

Yokohama, Japan

Location

Research Site

Zentsuji-shi, Japan

Location

Research Site

Aguascalientes, Mexico

Location

Research Site

Culiacán, Mexico

Location

Research Site

D.F, Mexico

Location

Research Site

Del. Cuauhtemoc, Mexico

Location

Research Site

Distrito Federal, Mexico

Location

Research Site

Monterrey, Mexico

Location

Research Site

Bellavista, Peru

Location

Research Site

Callao, Peru

Location

Research Site

Cusco, Peru

Location

Research Site

Lima, Peru

Location

Research Site

Baguio City, Philippines

Location

Research Site

Cagayan de Oro, Philippines

Location

Research Site

Cebu, Philippines

Location

Research Site

Iloilo City, Philippines

Location

Research Site

Manila, Philippines

Location

Research Site

Pasay, Philippines

Location

Research Site

Pasig, Philippines

Location

Research Site

Quezon City, Philippines

Location

Research Site

Bialystok, Poland

Location

Research Site

Chełm, Poland

Location

Research Site

Działdowo, Poland

Location

Research Site

Gdansk, Poland

Location

Research Site

Gmina Końskie, Poland

Location

Research Site

Gryfice, Poland

Location

Research Site

Katowice, Poland

Location

Research Site

Kielce, Poland

Location

Research Site

Krakow, Poland

Location

Research Site

Lodz, Poland

Location

Research Site

Lublin, Poland

Location

Research Site

Olsztyn, Poland

Location

Research Site

Ostrołęka, Poland

Location

Research Site

Sandomierz, Poland

Location

Research Site

Warsaw, Poland

Location

Research Site

Włocławek, Poland

Location

Research Site

Bucharest, Romania

Location

Research Site

Iași, Romania

Location

Research Site

Oradea, Romania

Location

Research Site

Sibiu, Romania

Location

Research Site

Târgu Mureş, Romania

Location

Research Site

Timișoara, Romania

Location

Research Site

Belgorod, Russia

Location

Research Site

Chelyabinsk, Russia

Location

Research Site

Irkutsk, Russia

Location

Research Site

Izhevsk, Russia

Location

Research Site

Kazan', Russia

Location

Research Site

Moscow, Russia

Location

Research Site

Nizhny Novgorod, Russia

Location

Research Site

Novosibirsk, Russia

Location

Research Site

Omsk, Russia

Location

Research Site

Perm, Russia

Location

Research Site

Saint Petersburg, Russia

Location

Research Site

Saratov, Russia

Location

Research Site

Ufa, Russia

Location

Research Site

Voronezh, Russia

Location

Research Site

Yaroslavl, Russia

Location

Research Site

Yekaterinburg, Russia

Location

Research Site

Levoča, Slovakia

Location

Research Site

Martin, Slovakia

Location

Research Site

Nitra, Slovakia

Location

Research Site

Spišská Nová Ves, Slovakia

Location

Research Site

Trnava, Slovakia

Location

Research Site

Žilina, Slovakia

Location

Research Site

Busan, South Korea

Location

Research Site

Daegu, South Korea

Location

Research Site

Gwangju, South Korea

Location

Research Site

Incheon, South Korea

Location

Research Site

Seongnam-si, South Korea

Location

Research Site

Seoul, South Korea

Location

Research Site

Wŏnju, South Korea

Location

Research Site

Albacete, Spain

Location

Research Site

Badalona(Barcelona), Spain

Location

Research Site

Barcelona, Spain

Location

Research Site

Girona, Spain

Location

Research Site

Lleida, Spain

Location

Research Site

Madrid, Spain

Location

Research Site

Pamplona, Spain

Location

Research Site

Santiago(A Coruña), Spain

Location

Research Site

Seville, Spain

Location

Research Site

Valencia, Spain

Location

Research Site

Valladolid, Spain

Location

Research Site

Falun, Sweden

Location

Research Site

Gothenburg, Sweden

Location

Research Site

Halmstad, Sweden

Location

Research Site

Karlstad, Sweden

Location

Research Site

Lidköping, Sweden

Location

Research Site

Linköping, Sweden

Location

Research Site

Malmo, Sweden

Location

Research Site

Mora, Sweden

Location

Research Site

Norrköping, Sweden

Location

Research Site

Östersund, Sweden

Location

Research Site

Stockholm, Sweden

Location

Research Site

Uppsala, Sweden

Location

Research Site

Västerås, Sweden

Location

Research Site

Aarau, Switzerland

Location

Research Site

Basel, Switzerland

Location

Research Site

Bern, Switzerland

Location

Research Site

Chur, Switzerland

Location

Research Site

Geneva, Switzerland

Location

Research Site

Lausanne, Switzerland

Location

Research Site

Lugano, Switzerland

Location

Research Site

Sankt Gallen, Switzerland

Location

Research Site

Villars-sur-Glâne, Switzerland

Location

Research Site

Zurich, Switzerland

Location

Research Site

Changhua, Taiwan

Location

Research Site

Chiayi City, Taiwan

Location

Research Site

Kaohsiung City, Taiwan

Location

Research Site

New Taipei City, Taiwan

Location

Research Site

Taichung, Taiwan

Location

Research Site

Tainan, Taiwan

Location

Research Site

Taipei, Taiwan

Location

Research Site

Taoyuan Hsien, Taiwan

Location

Research Site

Bangkok, Thailand

Location

Research Site

Chon Buri, Thailand

Location

Research Site

Khon Kaen, Thailand

Location

Research Site

Muang, Thailand

Location

Research Site

Patumthani, Thailand

Location

Research Site

Rajthevi, Thailand

Location

Research Site

Ratchathewi, Thailand

Location

Research Site

Ankara, Turkey (Türkiye)

Location

Research Site

Antalya, Turkey (Türkiye)

Location

Research Site

Eskişehir, Turkey (Türkiye)

Location

Research Site

Istanbul, Turkey (Türkiye)

Location

Research Site

Izmir, Turkey (Türkiye)

Location

Research Site

Konya, Turkey (Türkiye)

Location

Research Site

Ivano-Frankivsk, Ukraine

Location

Research Site

Kharkiv, Ukraine

Location

Research Site

Kyiv, Ukraine

Location

Research Site

Lutsk, Ukraine

Location

Research Site

Lviv, Ukraine

Location

Research Site

Uzhhorod, Ukraine

Location

Research Site

Vinnytsia, Ukraine

Location

Research Site

Zaporizhzhya, Ukraine

Location

Research Site

Hanoi, Vietnam

Location

Research Site

Ho Chi Minh City, Vietnam

Location

Research Site

Hochiminh, Vietnam

Location

Related Publications (12)

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Ischemic Attack, Transient

Interventions

TicagrelorAspirin

Condition Hierarchy (Ancestors)

Brain IschemiaCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

AdenosinePurine NucleosidesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesRibonucleosidesSalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Results Point of Contact

Title
Brilinta Global Clinical Lead
Organization
AstraZeneca R&D

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2013

First Posted

November 26, 2013

Study Start

January 7, 2014

Primary Completion

March 2, 2016

Study Completion

March 2, 2016

Last Updated

June 12, 2017

Results First Posted

June 12, 2017

Record last verified: 2017-05

Locations