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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01994720
First received: November 18, 2013
Last updated: May 12, 2017
Last verified: May 2017
  Purpose
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 Intervention Phase
Acute Ischaemic Stroke Transient Ischaemic Attack Drug: ticagrelor Drug: Acetylsalicylic acid (ASA) Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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:
  • 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).

  • 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).

  • 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).

  • 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).

  • 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).

  • 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)

  • 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.


  • 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)

  • 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).

  • 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).

  • 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.


  • 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.


  • 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.


  • 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.


  • 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.


  • 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.

  • 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).


Enrollment: 13307
Actual Study Start Date: January 7, 2014
Study Completion Date: March 2, 2016
Primary Completion Date: March 2, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   40 Years to 130 Years   (Adult, Senior)
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01994720

  Show 528 Study Locations
Sponsors and Collaborators
AstraZeneca
  More Information

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 )
Study First Received: November 18, 2013
Results First Received: March 7, 2017
Last Updated: May 12, 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

ClinicalTrials.gov processed this record on June 26, 2017