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

Completed · Phase 3

Conditions studied: Acute Ischaemic Stroke, Transient Ischaemic Attack

In brief

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).

Key facts

Study ID

NCT01994720

Run by

AstraZeneca

People needed

13307

Starts

2014-01-07

Expected to finish

2016-03-02

Last updated by the study team

2017-06-12

Who can join

Age: 40 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

• Research Site — Phoenix, Arizona, United States
• Research Site — Fayetteville, Arkansas, United States
• Research Site — Fort Smith, Arkansas, United States
• Research Site — Fullerton, California, United States
• Research Site — Glendale, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Newport, California, United States
• Research Site — Oakland, California, United States
• Research Site — San Diego, California, United States
• Research Site — Stanford, California, United States
• Research Site — Torrance, California, United States
• Research Site — Englewood, Colorado, United States
• Research Site — Altamonte Springs, Florida, United States
• Research Site — Aventura, Florida, United States
• Research Site — Boynton Beach, Florida, United States
• Research Site — Bradenton, Florida, United States
• Research Site — Gainesville, Florida, United States
• Research Site — Hialeah, Florida, United States
• Research Site — Jacksonville, Florida, United States
• Research Site — Lakeland, Florida, United States
• Research Site — Melbourne, Florida, United States
• Research Site — Pompano Beach, Florida, United States
• Research Site — Port Charlotte, Florida, United States
• Research Site — Sarasota, Florida, United States
• Research Site — Montgomery, Alabama, United States

Full record on ClinicalTrials.gov

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