ESPS-2
European Stroke Prevention Study
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Status:
Trial complete. Results published in November of 1996.
Purpose:
To study the effectiveness of dipyridamole and low-dose aspirin, taken alone or in combination, for secondary stroke prevention.
Design:
Randomized, double-blind, placebo-controlled, trial of 6602 patients at 59 centers.
Inclusion Criteria
Greater than 18 years of age, transient ischemic attack (TIA) or completed ischemic stroke within 3 months of entry.
Exclusion Criteria
Recent history of peptic ulcer or other gastrointestinal bleeding, bleeding disturbances, indication or contraindication to either study medication.
Patient Involvement:
Patients were randomized to participate in 1 of 4 groups. 1) aspirin (25 mg twice daily) 2) modified-release dipyridamole (200 mg twice daily) 3) aspirin (25 mg twice daily) and modified-release dipyridamole (200 mg twice daily) 4) placebo.
Primary Outcome:
Stroke, death, and stroke and/or death as determined in follow-up visits 1 month after inclusion and thereafter, every 3 months for 2 years.
Secondary Outcome:
TIA, myocardial infarction, ischemic events and other vascular events.
Results:
The 24-month stroke rate was 12.9% in the aspirin-alone group, 12.2% in the dipyridamole-alone group, 9.9% in the combination group and 15.8% in the placebo group. This difference among the four groups was significant (p<0.001). The results regarding the endpoint of stroke or death were similar but there was no significant difference among the groups for the endpoint of death (p=0.616). Stroke risk was significantly reduced by 18.1% in the aspirin-alone group, by 16.3% in the dipyridamole-alone group, and by 37.0% in the combination group compared to the placebo group.
Source of Information:
J Neurol Sci 1996 Nov; 143 (1-2):1-13.
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This information last updated on: 11/14/2000
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