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



Status:Completed
Conditions:Peripheral Vascular Disease, Neurology
Therapuetic Areas:Cardiology / Vascular Diseases, Neurology
Healthy:No
Age Range:40 - 127
Updated:4/21/2016
Start Date:January 2014
End Date:March 2016

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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.

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).


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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