The PRoFESS trial: future impact on secondary stroke prevention

Abstract

Patients with transient ischemic attack and ischemic stroke have a high risk of recurrent stroke and death. While aspirin is accepted as standard therapy in these patients, recent trials demonstrate that a combination of aspirin and extended-release dipyridamole or clopidogrel is superior to aspirin monotherapy. Blockade of the renin–angiotensin system with angiotensin-converting enzyme inhibitors or angiotensin-receptor blockers may also reduce recurrent stroke. The ongoing Prevention Regimen for Effectively Avoiding Second Strokes (PRoFESS) trial is designed to evaluate whether extended-release dipyridamole plus aspirin compared with clopidogrel, and whether telmisartan in addition to usual care, in individuals after a stroke, will reduce the risk of further strokes. PRoFESS is a multicenter, randomized, double-blind trial involving 695 sites from 35 countries or regions. The primary outcome for the trial is recurrent stroke, using a time-to-event analysis. Safety is evaluated by assessing the risk of major hemorrhagic and other serious adverse events. With over 20,000 patients randomized, and utilizing a 2 × 2 factorial design, PRoFESS is the largest stroke trial to investigate the prevention of recurrent stroke.

Keywords::

• aspirin
• blood pressure
• clopidogrel
• dipyridamole
• extended release
• placebo
• stroke
• stroke prevention
• stroke severity
• telmisartan
• TIA
• vascular dementia

Financial disclosure

The PRoFESS study is financially supported by Boehringer Ingelheim. Hans-Christoph Diener for the Publication Committee of the PRoFESS Study. Publication committee: P Bath, HC Diener, G Donnan, C Estol, R Roberts, P Teal, D Toni, R Sacco, S Yusuf, D Cotton and S Ounpuu.

HC Diener received honoraria for participation in clinical trials, contribution to advisory boards or oral presentations from: Abbott, AstraZeneca, Bayer Vital, Böehringer Ingelheim, D-Pharm, Fresenius, GlaxoSmithKline, Janssen Cilag, MSD, Novartis, Novo-Nordisk, Paion, Parke-Davis, Pfizer, Sanofi-Aventis, Sankyo, Servier, Solvay, Wyeth and Yamaguchi. Financial support for research projects was provided by: Astra/Zeneca, GSK, Böehringer Ingelheim, Novartis, Janssen-Cilag and Sanofi-Aventis. The Department of Neurology at the University Duisburg-Essen received research grants from the German Research Council, the German Ministry of Education and Research, the European Union, the Bertelsmann Foundation and the Heinz-Nixdorf Foundation. Diener has no ownership interests and does not own stocks of any pharmaceutical company.