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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01994720
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : June 12, 2017
Last Update Posted : June 12, 2017
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

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).

Condition or disease Intervention/treatment Phase
Acute Ischaemic Stroke Transient Ischaemic Attack Drug: ticagrelor Drug: Acetylsalicylic acid (ASA) Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13307 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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.
Actual Study Start Date : January 7, 2014
Actual Primary Completion Date : March 2, 2016
Actual Study Completion Date : March 2, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: ticagrelor Drug: ticagrelor
ticagrelor, 180 mg (two tablets of 90 mg) loading dose on Day 1 followed by 90 mg twice daily.

Active Comparator: Acetylsalicylic acid (ASA) Drug: Acetylsalicylic acid (ASA)
ASA, 300 mg (three tablets of 100 mg) on Day 1, followed by 100 mg once daily.




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. Number of Participants With Ischaemic Stroke [ Time Frame: From randomization up to 97 days ]
    Participants with ischaemic stroke. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

  2. Net Clinical Outcome [ Time Frame: From randomization up to 97 days ]
    Participants with stroke, MI, death or life-threatening bleeding. If no event, censoring occures at the minimum of (last date of event assessment, end of treatment date, day 97).

  3. Number of Participants With Composite of Ischaemic Stroke, MI and CV Death [ Time Frame: From randomization up to 97 days ]
    Participants with ischaemic stroke, MI or CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

  4. Number of Participants With All-Cause Death [ Time Frame: From randomization up to 97 days ]
    Participants with all-cause death. If no event, censoring at the minimum of (last date of event assessment, end of treatment date, day 97).

  5. Number of Participants With CV Death [ Time Frame: From randomization up to 97 days ]
    Participants with CV death. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

  6. Number of Participants With MI [ Time Frame: From randomization up to 97 days ]
    Participants with MI. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

  7. Number of Participants by Severity of Stroke and Overall Disability [ Time Frame: From randomization up to 97 days ]

    Analysis of severity of stroke and overall disability of patients, using the modified Rankin Score, mRS.

    Modified Rankin Score:

    0 - No symptoms.

    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.


  8. Number of Participants With Stroke [ Time Frame: From randomization up to 97 days ]
    Participants with stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97)

  9. Number of Participants With Fatal Stroke [ Time Frame: From randomization up to 97 days ]
    Participants with fatal stroke. If no event, censoring at the minimum of (last date of event assessment, date of death from non-CV causes, end of treatment date, day 97).

  10. Number of Participants With Disabling Stroke [ Time Frame: From randomization up to 97 days ]
    Participants with disabling stroke. If no event, censoring at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

  11. Change in NIHSS [ Time Frame: From randomization up to 97 days ]

    Change from baseline to end of treatment visit in NIHSS (National Institutes of Health Stroke Scale):

    0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke.


  12. EQ-5D at Visit 1 (Enrolment) [ Time Frame: Visit 1 (Enrolment) ]

    EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

    EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

    The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.


  13. EQ-5D at Visit 2 (Day 7+-2d) [ Time Frame: Visit 2 (Day 7+-2d) ]

    EQ-5D (EuroQol five dimensions questionnaire) index score using the UK tariff.

    EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

    The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.


  14. EQ-5D (EuroQol Five Dimensions Questionnaire) at End of Treatment Visit [ Time Frame: End of treatment visit (Day 90+-7d) ]

    EQ-5D index score using the UK tariff.

    EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

    The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.


  15. EQ-5D (EuroQol Five Dimensions Questionnaire) at Premature Treatment Discontinuation Visit [ Time Frame: Premature treatment discontinuation visit(<15 days after last dose) ]

    EQ-5D index score using the UK tariff.

    EQ-5D is a self assessment of 5 dimensions: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. For each dimension responders are asked to state their status on a three level ordinal scale; whether they experience no problems (Level 1), some problems (Level 2) or severe problems (Level 3). Health states defined by the 5 dimensions can be converted into a weighted health state index (health state utility) by applying scores from the EQ-5D value sets elicited from general population samples.

    The higher the index score the better the health state. In this study index scores ran from -0.59 to 1.


  16. Number of Participants With PLATO Major Bleeding Event [ Time Frame: From randomization up to 97 days ]

    Participants with PLATO Major bleeding. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).

    PLATO Major bleeding is defined as a bleed that is any one of:

    • 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.

  17. Number of Participants With Premature Discontinuation of Study Drug Due to Any Bleeding Adverse Event [ Time Frame: Time from first dose and up to and including 7 days following the date of last dose of the study ]
    Participants discontinuation of study drug due to any bleeding adverse event. If no event, censoring occures at the minimum of (last date of event assessment, date of death, end of treatment date, day 97).



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Ages Eligible for Study:   40 Years to 130 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01994720


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Osaka-shi, Japan
Research Site
Saga-shi, Japan
Research Site
Sagamihara-shi, Japan
Research Site
Saijo-shi, Japan
Research Site
Sakai-shi, Japan
Research Site
Sanuki-shi, Japan
Research Site
Sapporo-shi, Japan
Research Site
Sayama-shi, Japan
Research Site
Sendai-shi, Japan
Research Site
Shiroishi-shi, Japan
Research Site
Shizuoka-shi, Japan
Research Site
Suita-shi, Japan
Research Site
Suwa-shi, Japan
Research Site
Tachikawa-shi, Japan
Research Site
Takasaki-shi, Japan
Research Site
Takayama-shi, Japan
Research Site
Tokushima-shi, Japan
Research Site
Toyama-shi, Japan
Research Site
Toyohashi-shi, Japan
Research Site
Toyota-shi, Japan
Research Site
Tsu-shi, Japan
Research Site
Ube-shi, Japan
Research Site
Ueda-shi, Japan
Research Site
Uji-shi, Japan
Research Site
Ureshino-shi, Japan
Research Site
Utsunomiya-shi, Japan
Research Site
Yokohama-shi, Japan
Research Site
Zentsuji-shi, Japan
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, Korea, Republic of
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, Mexico
Peru
Research Site
Bellavista, Peru
Research Site
Callao, Peru
Research Site
Cusco, Peru
Research Site
Lima, Peru
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, Philippines
Poland
Research Site
Białystok, Poland
Research Site
Chełm, Poland
Research Site
Działdowo, Poland
Research Site
Gdańsk, Poland
Research Site
Gryfice, Poland
Research Site
Katowice, Poland
Research Site
Kielce, Poland
Research Site
Końskie, Poland
Research Site
Kraków, Poland
Research Site
Lublin, Poland
Research Site
Olsztyn, Poland
Research Site
Ostrołęka, Poland
Research Site
Sandomierz, Poland
Research Site
Warszawa, Poland
Research Site
Włocławek, Poland
Research Site
Łódź, Poland
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, Romania
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, Russian Federation
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, Slovakia
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, Spain
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
Stockholm, Sweden
Research Site
Uppsala, Sweden
Research Site
Västerås, Sweden
Research Site
Östersund, Sweden
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, Switzerland
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, Taiwan
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, Thailand
Turkey
Research Site
Ankara, Turkey
Research Site
Antalya, Turkey
Research Site
Eskisehir, Turkey
Research Site
Istanbul, Turkey
Research Site
Izmir, Turkey
Research Site
Konya, Turkey
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
Vinnytsia, Ukraine
Research Site
Zaporizhzhya, Ukraine
Vietnam
Research Site
Hanoi, Vietnam
Research Site
Ho Chi Minh City, Vietnam
Research Site
Hochiminh, Vietnam
Sponsors and Collaborators
AstraZeneca

Additional Information:
CSP  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01994720     History of Changes
Other Study ID Numbers: D5134C00001
2012-003895-38 ( EudraCT Number )
First Posted: November 26, 2013    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: June 12, 2017
Last Verified: May 2017

Keywords provided by AstraZeneca:
Acute ischaemic stroke.
Transient ischaemic attack.

Additional relevant MeSH terms:
Stroke
Ischemia
Cerebral Infarction
Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Aspirin
Ticagrelor
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Platelet Aggregation Inhibitors
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics