Acute Ischaemic StrokePhase 3SOCRATESNCT01994720

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

A Phase 3 study testing ticagrelor and Acetylsalicylic acid (ASA) in people with Acute Ischaemic Stroke and Transient Ischaemic Attack, run by AstraZeneca at 521 sites in 33 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 40 to 130 years
Conditions the study is for: Acute Ischaemic Stroke, Transient Ischaemic Attack
What is being tested?: ticagrelor and Acetylsalicylic acid (ASA)
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13,307 participants
Where: 521 sitesin 33 countries
Study dates: 7 Jan 2014to 2 Mar 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

521 sites in 33 countries.

Country

City, postcode or hospital

521 sites in 33 countries

United States115 sites

Research Site
Abington, Pennsylvania
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Akron, Ohio
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Albuquerque, New Mexico
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Alexandria, Louisiana
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Allentown, Pennsylvania
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Altamonte Springs, Florida
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Anderson, Indiana
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Annapolis, Maryland
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Aventura, Florida
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Bayonne, New Jersey
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Baytown, Texas
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Boston, Massachusetts
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Boynton Beach, Florida
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Bradenton, Florida
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Bridgeton, Missouri
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Brooklyn, New York
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Buffalo, New York
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Chapel Hill, North Carolina
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Charleston, South Carolina
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Charlotte, North Carolina
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Chattanooga, Tennessee
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Chicago, Illinois
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Clackamas, Oregon
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Cleveland, Ohio
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Columbia, Missouri
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Columbia, South Carolina
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Columbus, Georgia
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Columbus, Ohio
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Dallas, Texas
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Des Moines, Iowa
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Detroit, Michigan
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Doylestown, Pennsylvania
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Durham, North Carolina
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Edison, New Jersey
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El Paso, Texas
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Englewood, Colorado
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Englewood, New Jersey
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Erie, Pennsylvania
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Evanston, Illinois
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Fayetteville, Arkansas
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Flemington, New Jersey
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Fort Smith, Arkansas
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Fort Wayne, Indiana
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Frederick, Maryland
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Fullerton, California
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Gainesville, Florida
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Glendale, California
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Glenview, Illinois
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Great Falls, Montana
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Greensboro, North Carolina
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Harlingen, Texas
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Harvey, Illinois
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Helena, Montana
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Hershey, Pennsylvania
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Hialeah, Florida
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Houston, Texas
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Huntington, West Virginia
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Iowa City, Iowa
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Jacksonville, Florida
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Joliet, Illinois
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Kansas City, Missouri
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Kingwood, Texas
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Knoxville, Tennessee
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Lakeland, Florida
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Lebanon, New Hampshire
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Los Angeles, California
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Maumee, Ohio
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Melbourne, Florida
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Milwaukee, Wisconsin
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Minneapolis, Minnesota
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Montgomery, Alabama
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Morgantown, West Virginia
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Muncie, Indiana
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Nashville, Tennessee
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New Brunswick, New Jersey
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New Orleans, Louisiana
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New York, New York
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Newport, California
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Oakland, California
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Omaha, Nebraska
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Park Ridge, Illinois
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Philadelphia, Pennsylvania
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Phoenix, Arizona
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Pompano Beach, Florida
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Pontiac, Michigan
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Port Charlotte, Florida
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Portland, Oregon
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Providence, Rhode Island
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Richmond, Virginia
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Ridgewood, New Jersey
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Roanoke, Virginia
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Robbinsdale, Minnesota
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Royal Oak, Michigan
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Saint Paul, Minnesota
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San Diego, California
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Sarasota, Florida
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Seattle, Washington
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Sioux Falls, South Dakota
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Southfield, Michigan
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Southlake, Texas
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Springfield, Illinois
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St Louis, Missouri
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Stanford, California
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Stony Brook, New York
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Syracuse, New York
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Tampa, Florida
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The Bronx, New York
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Toledo, Ohio
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Torrance, California
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Urbana, Illinois
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West Bloomfield, Michigan
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West Orange, New Jersey
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West Palm Beach, Florida
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Weston, Florida
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Winston-Salem, North Carolina

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Japan88 sites

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Kyoto
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Nagoya
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Okayama
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Utsunomiya
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China26 sites

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Baotou
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France24 sites

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Antony
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Bordeaux
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Brest
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Bron
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Caen
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Créteil
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Dijon
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Lille
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Nice
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Pringy
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Rennes
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Rouen
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Saint-Herblain
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Saint-Priest-en-Jarez
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Strasbourg
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Toulouse
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Tours

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Italy19 sites

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Carrara
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Città di Castello
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Foligno
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Genova
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Gubbio
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Lecco
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Milan
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Modena
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Pavia
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Perugia
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Piacenza
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Pisa
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Roma
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Siena
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Varese
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Verona
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Poland16 sites

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Bialystok
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Chełm
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Działdowo
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Gdansk
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Gmina Końskie
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Gryfice
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Katowice
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Kielce
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Krakow
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Lodz
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Lublin
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Olsztyn
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Ostrołęka
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Sandomierz
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Warsaw
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Włocławek

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Russia16 sites

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Belgorod
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Chelyabinsk
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Irkutsk
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Izhevsk
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Kazan'
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Moscow
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Nizhny Novgorod
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Novosibirsk
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Omsk
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Perm
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Saint Petersburg
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Saratov
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Ufa
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Voronezh
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Yaroslavl
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Yekaterinburg

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Bulgaria15 sites

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Botevgrad
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Pazardzhik
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Pernik
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Pleven
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Plovdiv
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Rousse
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Sliven
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Sofia
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Yambol

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Germany13 sites

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Berlin
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Essen
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Frankfurt
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Hamburg
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Karlsruhe
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Minden
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Münster
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Osnabrück
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Wiesbaden

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Sweden13 sites

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Linköping
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Malmö
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Mora
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Australia12 sites

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Adelaide
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Herston
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Canada12 sites

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Edmonton, Alberta
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Greenfield Park, Quebec
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Montreal, Quebec
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Ottawa, Ontario
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Hungary12 sites

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Spain11 sites

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Lleida
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Madrid
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Pamplona
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Valencia
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Valladolid

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Belgium10 sites

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Aalst
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Czechia10 sites

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Switzerland10 sites

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Brazil8 sites

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Philippines8 sites

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Chile7 sites

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Mexico6 sites

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Slovakia6 sites

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Martin
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Žilina

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Turkey (Türkiye)6 sites

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Izmir
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Konya

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About this study

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.

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).

Conditions: Acute Ischaemic Stroke, Transient Ischaemic Attack
Being tested: ticagrelor, Acetylsalicylic acid (ASA)
Keywords: Acute ischaemic stroke., Transient ischaemic attack.
Medical subject headings: Ischemic Attack, Transient

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ticagrelorDrug
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.
Acetylsalicylic acid (ASA)Drug
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.

Study groups in NCT01994720
Study group	Role	What they receive
ticagrelor	Experimental	Not described Receives: Drug: ticagrelor
Acetylsalicylic acid (ASA)	Active comparator	Not described Receives: Drug: Acetylsalicylic acid (ASA)

What is being measured

The primary outcome is the main question the study is designed to answer.

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).
Measured: From randomization up to 97 days

Secondary outcomes (17)

Number of Participants With Ischaemic Stroke
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).
Measured: From randomization up to 97 days
Net Clinical Outcome
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).
Measured: From randomization up to 97 days
Number of Participants With Composite of Ischaemic Stroke, MI and CV Death
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).
Measured: From randomization up to 97 days
Number of Participants With All-Cause Death
Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).
Measured: From randomization up to 97 days
Number of Participants With CV Death
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).
Measured: From randomization up to 97 days
Number of Participants With MI
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)
Measured: From randomization up to 97 days
Number of Participants by Severity of Stroke and Overall Disability
Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.
Modified Rankin Score:
0 - No symptoms.
1. - No significant disability. Able to carry out all usual activities, despite some symptoms.
2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
3. - Moderate disability. Requires some help, but able to walk unassisted.
4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
6. - Dead.
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.
Measured: From randomization up to 97 days
Number of Participants With Stroke
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)
Measured: From randomization up to 97 days
Number of Participants With Fatal Stroke
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).
Measured: From randomization up to 97 days
Number of Participants With Disabling Stroke
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).
Measured: From randomization up to 97 days
Change in NIHSS
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.
Measured: From randomization up to 97 days
EQ-5D at 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.
Measured: Visit 1 (Enrolment)
EQ-5D at 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.
Measured: Visit 2 (Day 7+-2d)
EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit
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.
Measured: End of treatment visit (Day 90+-7d)
EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
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.
Measured: Premature treatment discontinuation visit(<15 days after last dose)
Number of Participants With PLATO Major Bleeding Event
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:
- Fatal
- Intracranial (excluding asymptomatic haemorrhagic transformations of ischemic brain infarctions and excluding micro-hemorrhages <10 mm evident only on gradient-echo MRI)
- Intrapericardial bleed with cardiac tamponade
- Hypovolaemic shock or severe hypotension due to bleeding and requiring pressors or surgery
- Significantly disabling (eg. intraocular with permanent vision loss)
- Clinically overt or apparent bleeding associated with a decrease in Hb of more than 30 g/L (1.9 mmol/L; 0.465 mmol/L)
- Transfusion of 2 or more units (whole blood or packed red blood cells [PRBCs]) for bleeding.
Measured: From randomization up to 97 days
Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event
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).
Measured: Time from first dose and up to and including 7 days following the date of last dose of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jan 20142 Mar 2016

First posted26 Nov 2013 (estimated)
Study start7 Jan 2014
Primary completion2 Mar 2016
Study completion2 Mar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (12)Papers the sponsor has linked to this study.
Other trials for Acute Ischaemic StrokeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 13,307 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01994720
Sponsor's protocol ID: D5134C00001
Other IDs: 2012-003895-38
Acronym: SOCRATES
Status last verified: May 2017
First submitted: 18 Nov 2013
Last updated: 12 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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.
PubMed 35538232
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.
PubMed 32666831
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.
PubMed 31296654
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.
PubMed 31092152
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.
PubMed 30776996
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.
PubMed 29915123
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.
PubMed 28720658
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.
PubMed 28655834
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.
PubMed 28238711
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.
PubMed 27899747
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.
PubMed 27160944
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.
PubMed 27160892

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Acute Ischaemic Stroke trials

Study at a glance

From the registry record, last updated by the sponsor on 12 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT01994720
Acronym / sponsor ID: SOCRATES / D5134C00001
Conditions: Acute Ischaemic Stroke, Transient Ischaemic Attack
Keywords: Acute ischaemic stroke., Transient ischaemic attack.
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13,307 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: 7 Jan 2014 (actual)
Primary completion: 2 Mar 2016 (actual)
Study completion: 2 Mar 2016 (actual)
First posted: 26 Nov 2013 (estimated)
Results: Posted 12 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Prevention
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
ticagrelor	Experimental	Drug: ticagrelor
Acetylsalicylic acid (ASA)	Active comparator	Drug: Acetylsalicylic acid (ASA)

Who may qualify

Ages: 40 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (2 listed)

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 (1 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ticagrelorticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.	Drug	ticagrelor
Acetylsalicylic acid (ASA)ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.	Drug	Acetylsalicylic acid (ASA)

Primary outcome

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).

17 secondary outcomes

Number of Participants With Ischaemic Stroke
Time frame: From randomization up to 97 days
Net Clinical Outcome
Time frame: 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
Number of Participants With All-Cause Death
Time frame: From randomization up to 97 days
Number of Participants With CV Death
Time frame: From randomization up to 97 days
Number of Participants With MI
Time frame: From randomization up to 97 days
Number of Participants by Severity of Stroke and Overall Disability
Time frame: From randomization up to 97 days
Number of Participants With Stroke
Time frame: From randomization up to 97 days
Number of Participants With Fatal Stroke
Time frame: From randomization up to 97 days
Number of Participants With Disabling Stroke
Time frame: From randomization up to 97 days
Change in NIHSS
Time frame: From randomization up to 97 days
EQ-5D at Visit 1 (Enrolment)
Time frame: Visit 1 (Enrolment)
EQ-5D at Visit 2 (Day 7+-2d)
Time frame: 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 (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit
Time frame: 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
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

Results and safety

Results posted to the registry on 12 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ticagrelor 90 mg	6,589	6,543
ASA 100 mg	6,610	6,554

Primary outcome: Number of Participants With Composite of Stroke/MI/Death

Time frame: From randomization up to 97 days. Number. Unit: Participants

Measure	Ticagrelor 90 mg n = 6589	ASA 100 mg n = 6610
Value	442	497

Ticagrelor 90 mg vs ASA 100 mg: Hazard Ratio (HR): 0.89 (95% CI 0.78 to 1.01), p = 0.0670, Regression, Cox

Population analysed: The population was the full analysis set, which included all randomized patients.

17 secondary outcomes are reported in the full results.

Adverse events

Time frame: On or after the date of first dose and up to and including 7 days following the date of last dose of study medication. 97 days if the participant completed treatment according to the study plan.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
ASA 100mg	533 of 6,581 (8.1%)	85 of 6,581 (1.3%)	Not reported
Ticagrelor 90mg	532 of 6,549 (8.1%)	383 of 6,549 (5.8%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35538232Diener 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.
Derived from this study: PubMed 32666831Evans 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.
Derived from this study: PubMed 31296654Cucchiara 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.
Derived from this study: PubMed 31092152Easton 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.
Derived from this study: PubMed 30776996Molina 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.
Derived from this study: PubMed 29915123Wong 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.
Derived from this study: PubMed 28720658Amarenco 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.
Derived from this study: PubMed 28655834Easton 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.
Derived from this study: PubMed 28238711Amarenco 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.
Derived from this study: PubMed 27899747Wang 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.
Derived from this study: PubMed 27160944Held 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.
Derived from this study: PubMed 27160892Johnston 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.
CSPLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

521 sites in 33 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ticagrelor and Acetylsalicylic acid (ASA) in people with Acute Ischaemic Stroke and Transient Ischaemic Attack, run by AstraZeneca at 521 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 521 sites in United States, Japan, China, France, Italy and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 12 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Composite of Stroke/MI/Death (time frame: From randomization up to 97 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01994720, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2017.