[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):
ClinicalTrials.gov 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Prevention of subsequent ischaemic stroke. [ Time Frame: From randomization up to 90 days ] [ Designated as safety issue: No ]
    Comparison of the effects of treatment with ticagrelor vs ASA.

  • Net clinical outcome. [ Time Frame: From randomization up to 90 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
  • Composite of ischaemic stroke, MI and CV death. [ Time Frame: From randomization up to 90 days ] [ Designated as safety issue: No ]

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
Genders Eligible for Study:   Both
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.
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01994720

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

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01994720     History of Changes
Other Study ID Numbers: D5134C00001  2012-003895-38 
Study First Received: November 18, 2013
Last Updated: April 6, 2016
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on May 26, 2016