The PRoFESS trial: future impact on secondary stroke prevention.
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 x 2 factorial design, PRoFESS is the largest stroke trial to investigate the prevention of recurrent stroke.
Diener
Hans-Christoph
HC
University Duisburg-Essen, Department of Neurology, Hufelandstrasse 55, 45122 Essen, Germany. h.diener@uni-essen.de
D000806:Angiotensin-Converting Enzyme Inhibitors / Q000008:administration & dosage; D001241:Aspirin / Q000008:administration & dosage*; D001562:Benzimidazoles / Q000008:administration & dosage*; D001565:Benzoates / Q000008:administration & dosage*; D002545:Brain Ischemia / Q000150:complications / Q000188:drug therapy*; D000077144:Clopidogrel; D004176:Dipyridamole / Q000008:administration & dosage*; D004359:Drug Therapy, Combination; D005544:Forecasting; D006801:Humans; D038622:Internationality; D010975:Platelet Aggregation Inhibitors / Q000008:administration & dosage; D016032:Randomized Controlled Trials as Topic; D055502:Secondary Prevention; D020521:Stroke / Q000209:etiology / Q000517:prevention & control*; D000077333:Telmisartan; D013988:Ticlopidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D016896:Treatment Outcome; D014665:Vasodilator Agents / Q000008:administration & dosage
D000806:Angiotensin-Converting Enzyme Inhibitors; D001562:Benzimidazoles; D001565:Benzoates; D010975:Platelet Aggregation Inhibitors; D014665:Vasodilator Agents; D004176:Dipyridamole; D000077144:Clopidogrel; D013988:Ticlopidine; D001241:Aspirin; D000077333:Telmisartan