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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.
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 18, 2013
Last updated: April 6, 2016
Last verified: March 2016
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: Double Blind (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:
  • Composite of stroke, MI and death. [ Time Frame: From randomization up to 90 days ]

Secondary Outcome Measures:
  • Prevention of subsequent ischaemic stroke. [ Time Frame: From randomization up to 90 days ]
    Comparison of the effects of treatment with ticagrelor vs ASA.

  • Net clinical outcome. [ Time Frame: From randomization up to 90 days ]
    stroke + MI + death + life threatening bleeding

  • Time to discontinuation of study medication due to any bleeding event. [ Time Frame: From randomization up to 90 days ]
  • Composite of ischaemic stroke, MI and CV death. [ Time Frame: From randomization up to 90 days ]

Enrollment: 13307
Study Start Date: January 2014
Study Completion Date: March 2016
Primary Completion Date: March 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 or corresponding placebo given orally.
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 or corresponding placebo given orally.


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

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
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Please refer to this study by its identifier: NCT01994720

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Sponsors and Collaborators
  More Information

Additional Information:
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Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: AstraZeneca Identifier: NCT01994720     History of Changes
Other Study ID Numbers: D5134C00001
2012-003895-38 ( EudraCT Number )
Study First Received: November 18, 2013
Last Updated: April 6, 2016

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

Additional relevant MeSH terms:
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
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
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 processed this record on May 22, 2017