PRoFESS Trial

Diener HC , Sacco R, Yusud S et al. Rationale, design and baseline data of a randomized, double blind controlled trial comparing two antithromobotic regiments (a fixed dose combinations of ER dipyridamole and plus ASA with clopidogrel) and telmisartan versus placebo in patients with strokes: the prevention regiment for effectively avoiding second strokes trial. Cereebrovasc Dis 2007; 23:368-380.

Blogger comment: The authors were obviously science and not English majors, and the lower case "O" is annoying. In sum this study compares aggrenox against plavix, and makes a side study of telmisartan.

There are 695 sites from 35 countries, involving patients over 50 with stroke within 120 days, with recurrent stroke as the primary outcome in a time to event analysis. The secondary outcome measure is the composite of stroke, MI or vascular death. The main study is non-inferiority, then superiority and the side study assesses suuperiority over placebo. Over 20,000 patients are randomized. The mean age was 66, 2:1 male, large and small vessel strokes are included. The deisgn is 2 x 2 factorial design.

The expected event rate in the clopidogrel group was 5.25 % per year, necessitating 15,500 subjects but the number was increased when the event rate turned out to be lower.