Table 1.
Randomized clinical trials on aspirin plus dipyridamole after stroke or TIA.
| Trial | Population | Antiplatelet regimen | Endpoints | Major findings |
|---|---|---|---|---|
| ESPS-2 [22] | 6602 patients with prior (<3 months) TIA or ischemic stroke | Aspirin 25 mg twice daily or ER-dipyridamole 200 mg twice daily oraspirin 25 mg plus ER-dipyridamole 200 mg twice daily or placebo | Stroke (fatal or nonfatal), death, stroke and/or death | Significant risk reduction (37%, P < .001) in primary endpoint with combination therapy |
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| ESPRIT [23] | 2603 patients with prior (<6 months) TIA or minor ischemic stroke of arterial origin | Aspirin 30–325 mg/d plus dipyridamole 200 mg twice daily or aspirin 30–325 mg/d alone | Vascular death, nonfatal stroke, nonfatal MI, or major bleeding complication | Significant relative risk reduction (20%, hazard ratio 0.80, 95% CI 0.66–0.98) in the primary endpoint with combination therapy |
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| PROFESS [24] | 20332 patients with prior stroke (<3 months) | Aspirin 25 mg plus ER-dipyridamole 200 mg twice daily or clopidogrel 75 mg/d alone | Stroke recurrence and composite of stroke, MI, or vascular death | The trial did not meet the predefined criteria for noninferiority. Recurrent stroke: 9.0% ER-dipyridamole plus aspirin, 8.8% clopidogrel; hazard ratio 1.01, 95% CI 0.92–1.11. Composite endpoint: 13.1% ER-dipyridamole plus aspirin, 13.1% clopidogrel; hazard ratio 0.99, 95% CI 0.92–1.07, P = .83 |
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| EARLY [25] | 543 patients with ischemic stroke within 24 hours of symptomonset | Aspirin 25 mg plus ER-dipyridamole 200 mg twice daily or aspirin 100 mg/d alone for 7 days. All patients were then given aspirin plus ER-dipyridamole for up to 90 day | Functional neurological status (mRS) at 90 days. Vascular adverse events (nonfatal stroke, TIA, nonfatal MI, and major bleeding complications) and mortality within first 90 days | No significant difference between the groups in good functional outcome (mRS 0–2; OR 1.37, 95% CI 0.86–2.18, P = .19). No significant difference between the groups in composite endpoint (hazard ratio 0.73, 95% CI 0.44–1.19, P = .20) |
Legend: TIA: transient ischemic attack; ER: extended released; MI: myocardial infarction; CI: confidence interval.