UK-TIA
United Kingdom Transient Ischaemic Attack Aspirin Trial
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Status:
Trial complete. Results published in 1991.
Purpose:
To compare the relative efficacies of two different doses of aspirin taken daily on a long-term basis in the secondary prevention of stroke.
Location(s):
United Kingdom
Design:
Randomized, double-blind, placebo-controlled trial of 2435 patients at 33 centers.
Inclusion Criteria
Presumed TIA or minor ischemic stroke.
Exclusion Criteria
Less than 40 years of age, cerebrovascular event presenting > 3 months after onset, previous disabling major stroke, attacks due to something other than arterial thromboembolism, previous allergy or intolerance to aspirin, previous abnormal bleeding, alcoholism, chronic renal failure, peptic ulceration in previous 3 years, need for regular aspirin treatment or any other antihemostatic medication, prior aspirin therapy likely to confound trial analysis, myocardial infarction within previous 3 months, factors that might create difficulties with follow-up and/or compliance, severe intercurrent non-vascular disease.
Patient Involvement:
Patients were randomized to receive either aspirin two 300 mg tablets twice daily, aspirin two 150 mg tablets once daily and placebo once daily, or placebo twice daily. If patients complained of indigestion they were advised to omit the second daily dose of tablets. If they still complained of indigestion, they were told to take just one tablet of the first daily dose. If indigestion persisted, they were advised to transfer to enteric coated trial medication and if necessary reduce dose to one tablet daily. Patients were seen every 4 months until the scheduled end of the trial or prior death or emigration. If they were not able or willing to go the neurological clinics for follow-up, their general practitioners were contacted for information. Treatment was continued for an average of four years range .
Primary Outcome:
Time to composite event of major stroke (modified Rankin scale score >=3), myocardial infarction or vascular death.
Secondary Outcome:
Adverse effects.
Results:
Analysis by intention-to-treat showed the odds of suffering a major stroke, myocardial infarction or vascular death were not significantly reduced by aspirin treatment (odds reduction 15%, 95% CI 29% odds reduction to 3% odds increase). There was no significant difference between the treatment groups in the composite event of major disabling stroke and/or vascular death or vascular death alone. There was no definite difference between responses to the 300 mg and 1200 mg daily doses, except that the lower dose was significantly less gastrotoxic.
Source of Information:
Published reports 1996.
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This information last updated on: 4/30/2001
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