PRoFESS
Trial question
What is the role of combination of aspirin and ER dipyridamole in patients with a recent stroke?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 20332
20332 patients (7310 female, 13022 male)
Inclusion criteria: patients with a recent ischemic stroke
Key exclusion criteria: contraindications to one of the antiplatelet agents, primary hemorrhagic stroke, brain tumor, dementia requiring institutional care, or a mRS score > 4 at baseline
Interventions
N=10181 ASA-ERDP (aspirin 25 mg plus 200 mg ER dipyridamole BID)
N=10151 clopidogrel (75 mg daily)
Primary outcome
Recurrent stroke
9
8.8
9.0 %
6.8 %
4.5 %
2.3 %
0.0 %
ASA-ERDP
Clopidogrel
No significant
difference ↔
No significant difference in recurrent stroke (9% vs. 8.8%; HR 1.01, 95% CI 0.92 to 1.11)
Secondary outcomes
No significant difference in stroke, myocardial infarction, or death from vascular causes (13.1% vs. 13.1%; HR 0.99, 99% CI 0.92 to 1.07)
No significant difference in recurrent stroke or major hemorrhagic event (11.7% vs. 11.4%; HR 1.03, 95% CI 0.95 to 1.11)
No significant difference in myocardial infarction (1.7% vs. 1.9%; HR 0.9, 95% CI 0.73 to 1.1)
Safety outcomes
No significant differences in frequency of death, any hemorrhagic event, TTP or neutropenia.
Significant differences in major hemorrhagic events (4.1% vs. 3.6%), ICH (1.4% vs. 1.0%).
Conclusion
In patients with a recent ischemic stroke, ASA-ERDP was not superior to clopidogrel with respect to recurrent stroke.
Reference
Sacco RL, Diener HC, Yusuf S et al. Aspirin and extended-release dipyridamole versus clopidogrel for recurrent stroke. N Engl J Med. 2008 Sep 18;359(12):1238-51.
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