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

Not Recruiting

Trial ID: NCT01994720

Age - 40 Years-130 Years Condition - Transient Ischemic Attack Gender - All Accepting Healthy Volunteers - No

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).

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.

Eligibility


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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Intervention(s):

drug: ticagrelor

drug: Acetylsalicylic acid (ASA)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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