[SOCRATES -Acute Stroke Or Transient IsChaemic Attack TReated With Aspirin or Ticagrelor and Patient OutcomES]

Acute Ischaemic Stroke Clinical Trial

— SOCRATES  

Official title:

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01994720
• Other study ID #: D5134C00001
• Secondary ID: 2012-003895-38
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2013
• Last updated: April 6, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13307
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 130 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Acute Ischaemic Stroke
• Ischemia
• Ischemic Attack, Transient
• Stroke
• Transient Ischaemic Attack.

Intervention

Drug:
• ticagrelor
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily or corresponding placebo given orally.
• Acetylsalicylic acid (ASA)
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily or corresponding placebo given orally.

Locations

Country	Name	City	State
Argentina	Research Site	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
Australia	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
Belgium	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
Brazil	Research Site	Botucatu
Brazil	Research Site	Curitiba
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Ribeirao Preto
Brazil	Research Site	Salvador
Brazil	Research Site	São José do Rio Preto
Brazil	Research Site	Sao Paulo
Bulgaria	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
Canada	Research Site	Calgary	Alberta
Canada	Research Site	Chicoutimi	Quebec
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Greenfield Park	Quebec
Canada	Research Site	London	Ontario
Canada	Research Site	Montreal	Quebec
Canada	Research Site	Ottawa	Ontario
Canada	Research Site	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Thunder Bay	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Vancouver	British Columbia
Chile	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
China	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
Czech Republic	Research Site	Brno
Czech Republic	Research Site	Chomutov
Czech Republic	Research Site	Hradec Kralove
Czech Republic	Research Site	Jihlava
Czech Republic	Research Site	Liberec
Czech Republic	Research Site	Olomouc
Czech Republic	Research Site	Ostrava
Czech Republic	Research Site	Pardubice
Czech Republic	Research Site	Praha 2
Czech Republic	Research Site	Trutnov
France	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
France	Research Site	PARIS Cedex 12
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
Germany	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
Hong Kong	Research Site	Hong Kong
Hong Kong	Research Site	Hongkong
Hong Kong	Research Site	Kowloon
Hong Kong	Research Site	Shatin
Hungary	Research Site	Balassagyarmat
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Gyor
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	Székesfehérvár
Hungary	Research Site	Szekszárd
Israel	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
Italy	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
Japan	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
Korea, Republic of	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
Mexico	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
Peru	Research Site	Bellavista
Peru	Research Site	Callao
Peru	Research Site	Cusco
Peru	Research Site	Lima
Philippines	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
Poland	Research Site	Bialystok
Poland	Research Site	Chelm
Poland	Research Site	Dzialdowo
Poland	Research Site	Gdansk
Poland	Research Site	Gryfice
Poland	Research Site	Katowice
Poland	Research Site	Kielce
Poland	Research Site	Konskie
Poland	Research Site	Kraków
Poland	Research Site	Lódz
Poland	Research Site	Lublin
Poland	Research Site	Olsztyn
Poland	Research Site	Ostroleka
Poland	Research Site	Sandomierz
Poland	Research Site	Warszawa
Poland	Research Site	Wloclawek
Romania	Research Site	Bucharest
Romania	Research Site	Iasi
Romania	Research Site	Oradea
Romania	Research Site	Sibiu
Romania	Research Site	Timisoara
Romania	Research Site	Tirgu-Mures
Russian Federation	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
Slovakia	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
Spain	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
Sweden	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	Östersund
Sweden	Research Site	Stockholm
Sweden	Research Site	Uppsala
Sweden	Research Site	Västerås
Switzerland	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
Taiwan	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
Thailand	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
Turkey	Research Site	Ankara
Turkey	Research Site	Antalya
Turkey	Research Site	Eskisehir
Turkey	Research Site	Istanbul
Turkey	Research Site	Izmir
Turkey	Research Site	Konya
Ukraine	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	Vinnytsya
Ukraine	Research Site	Zaporizhzhya
United States	Research Site	Abington	Pennsylvania
United States	Research Site	Akron	Ohio
United States	Research Site	Albuquerque	New Mexico
United States	Research Site	Alexandria	Louisiana
United States	Research Site	Allentown	Pennsylvania
United States	Research Site	Anderson	Indiana
United States	Research Site	Annapolis	Maryland
United States	Research Site	Aventura	Florida
United States	Research Site	Bayonne	New Jersey
United States	Research Site	Baytown	Texas
United States	Research Site	Boston	Massachusetts
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Bradenton	Florida
United States	Research Site	Bridgeton	Missouri
United States	Research Site	Bronx	New York
United States	Research Site	Brooklyn	New York
United States	Research Site	Buffalo	New York
United States	Research Site	Chapel Hill	North Carolina
United States	Research Site	Charleston	South Carolina
United States	Research Site	Charlotte	North Carolina
United States	Research Site	Chattanooga	Tennessee
United States	Research Site	Chicago	Illinois
United States	Research Site	Clackamas	Oregon
United States	Research Site	Cleveland	Ohio
United States	Research Site	Columbia	Missouri
United States	Research Site	Columbia	South Carolina
United States	Research Site	Columbus	Ohio
United States	Research Site	Columbus	Georgia
United States	Research Site	Dallas	Texas
United States	Research Site	Des Moines	Iowa
United States	Research Site	Detroit	Michigan
United States	Research Site	Doylestown	Pennsylvania
United States	Research Site	Durham	North Carolina
United States	Research Site	Edison	New Jersey
United States	Research Site	El Paso	Texas
United States	Research Site	Englewood	New Jersey
United States	Research Site	Englewood	Colorado
United States	Research Site	Erie	Pennsylvania
United States	Research Site	Evanston	Illinois
United States	Research Site	Fayetteville	Arkansas
United States	Research Site	Flemington	New Jersey
United States	Research Site	Fort Smith	Arkansas
United States	Research Site	Fort Wayne	Indiana
United States	Research Site	Frederick	Maryland
United States	Research Site	Fullerton	California
United States	Research Site	Gainesville	Florida
United States	Research Site	Glendale	California
United States	Research Site	Glenview	Illinois
United States	Research Site	Great Falls	Montana
United States	Research Site	Greensboro	North Carolina
United States	Research Site	Harlingen	Texas
United States	Research Site	Harvey	Illinois
United States	Research Site	Helena	Montana
United States	Research Site	Hershey	Pennsylvania
United States	Research Site	Hialeah	Florida
United States	Research Site	Houston	Texas
United States	Research Site	Huntington	West Virginia
United States	Research Site	Iowa City	Iowa
United States	Research Site	Jacksonville	Florida
United States	Research Site	Joliet	Illinois
United States	Research Site	Kansas City	Missouri
United States	Research Site	Kingwood	Texas
United States	Research Site	Knoxville	Tennessee
United States	Research Site	Lakeland	Florida
United States	Research Site	Lebanon	New Hampshire
United States	Research Site	Los Angeles	California
United States	Research Site	Maumee	Ohio
United States	Research Site	Melbourne	Florida
United States	Research Site	Milwaukee	Wisconsin
United States	Research Site	Minneapolis	Minnesota
United States	Research Site	Montgomery	Alabama
United States	Research Site	Morgantown	West Virginia
United States	Research Site	Muncie	Indiana
United States	Research Site	Nashville	Tennessee
United States	Research Site	New Brunswick	New Jersey
United States	Research Site	New Orleans	Louisiana
United States	Research Site	New York	New York
United States	Research Site	Newport	California
United States	Research Site	Oakland	California
United States	Research Site	Omaha	Nebraska
United States	Research Site	Park Ridge	Illinois
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Phoenix	Arizona
United States	Research Site	Pompano Beach	Florida
United States	Research Site	Pontiac	Michigan
United States	Research Site	Port Charlotte	Florida
United States	Research Site	Portland	Oregon
United States	Research Site	Providence	Rhode Island
United States	Research Site	Richmond	Virginia
United States	Research Site	Ridgewood	New Jersey
United States	Research Site	Roanoake	Virginia
United States	Research Site	Robbinsdale	Minnesota
United States	Research Site	Royal Oak	Michigan
United States	Research Site	San Diego	California
United States	Research Site	Sarasota	Florida
United States	Research Site	Seattle	Washington
United States	Research Site	Sioux Falls	South Dakota
United States	Research Site	Southfield	Michigan
United States	Research Site	Southlake	Texas
United States	Research Site	Springfield	Illinois
United States	Research Site	St Louis	Missouri
United States	Research Site	St Paul	Minnesota
United States	Research Site	St. Louis	Missouri
United States	Research Site	Stanford	California
United States	Research Site	Stony Brook	New York
United States	Research Site	Syracuse	New York
United States	Research Site	Tampa	Florida
United States	Research Site	Toledo	Ohio
United States	Research Site	Torrance	California
United States	Research Site	Urbana	Illinois
United States	Research Site	West Bloomfield	Michigan
United States	Research Site	West Orange	New Jersey
United States	Research Site	West Palm Beach	Florida
United States	Research Site	Weston	Florida
United States	Research Site	Winston Salem	North Carolina
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh City
Vietnam	Research Site	Hochiminh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Czech Republic,  France,  Germany,  Hong Kong,  Hungary,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Peru,  Philippines,  Poland,  Romania,  Russian Federation,  Slovakia,  Spain,  Sweden,  Switzerland,  Taiwan,  Thailand,  Turkey,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite of stroke, MI and death.		From randomization up to 90 days	No
Secondary	Prevention of subsequent ischaemic stroke.	Comparison of the effects of treatment with ticagrelor vs ASA.	From randomization up to 90 days	No
Secondary	Net clinical outcome.	stroke + MI + death + life threatening bleeding	From randomization up to 90 days	No
Secondary	Time to discontinuation of study medication due to any bleeding event.		From randomization up to 90 days	Yes
Secondary	Composite of ischaemic stroke, MI and CV death.		From randomization up to 90 days	No

External Links

•   CSP