Trial record 20 of 237 for:    Transient Ischemic Attack

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

This study is currently recruiting participants.
Verified February 2014 by AstraZeneca
Information provided by (Responsible Party):
AstraZeneca Identifier:
First received: November 18, 2013
Last updated: February 11, 2014
Last verified: February 2014

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 ]

Estimated Enrollment: 10560
Study Start Date: January 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (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 and older
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.
  Contacts and Locations
Please refer to this study by its identifier: NCT01994720

Contact: Nardev Khurmi, MD
Contact: Peter Held

  Show 272 Study Locations
Sponsors and Collaborators
  More Information

No publications provided

Responsible Party: AstraZeneca Identifier: NCT01994720     History of Changes
Other Study ID Numbers: D5134C00001, 2012-003895-38
Study First Received: November 18, 2013
Last Updated: February 11, 2014
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
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Hematologic Agents processed this record on April 16, 2014