PRoFESS® - Results
Please note: Aggrenox® did not meet the predefined statistical non-inferiority margin versus clopidogrel. Both regimens show comparable efficacy.
Primary outcome
First recurrence of stroke was confirmed in 1,814 patients.
In 916 recipients (9.0%) treated with extended-release dipyridamole plus ASA
and 898 recipients (8.8%) treated with clopidogrel, a first recurrent stroke occurred
(hazard ratio, 1.01; 95% CI, 0.92 to 1.11).
The results for the primary outcome had a hazard ratio very close to 1.00
(representing equivalence). However, the upper limit of the confidence
interval extended beyond the non-inferiority margin of 1.075.
Time Until Recurrent Stroke
* Covariates in Cox model are age, baseline ACE-inhibitor use, modified Rankin, and baseline diabetes status.
References
Sacco RL, Diener HC, Yusuf S et al. N Engl J Med 2008; 359.
PubMed Abstract
