PRoFESS® (Prevention Regimen For Effectively avoiding Second Strokes) involves more than 20,300 patients from 720 sites throughout Asia, Australia, Europe, North and South America and South Africa, for an observation period of up to 4 years, is sponsored by Boehringer Ingelheim and is the largest-ever secondary stroke prevention trial conducted.
PRoFESS® Overview
| Duration: | 4 years follow up | ||||||
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| Results expected: | May 2008 at the European Stroke Conference | ||||||
| Clinical outcome: | Aggrenox®/Asasantin® (extended-release dipyridamole + ASA) is superior to clopidogrel in secondary stroke prevention. | ||||||
| Study design: (2 x 2 factorial) |
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| Lead investigator: | Professor Hans-Christoph Diener Head of Neurology University Duisburg-Essen Germany |
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| Online activities: | www.profess-study.com | ||||||
Key findings for the PRoFESS® study
As stroke is the third-leading cause of death and the leading cause of neurological disability worldwide, prevention of recurrent stroke is an important therapeutic goal.
The concept for the PRoFESS® study is based on two key findings
1. Combination antiplatelet agents are more effective in the secondary prevention of stroke than single agents, as shown in the ESPS 2 trial comparing Aggrenox®/Asasantin® vs. ASA alone. The results of the CURE study have also demonstrated that clopidogrel + ASA was significantly superior to ASA alone in preventing cardiovascular events, although this was not in a stroke population. The potential benefits of combining clopidogrel with ASA vs. clopidogrel alone was investigated in a stroke population in the MATCH trial, but the trial failed while the risk of life- threatening or major bleeding is increased by the addition of aspirin.
2. Blood pressure is an important risk factor for stroke but in addition a variety of other important factors increase the risk of stroke, e.g.: vascular factors such as atherosclerosis, endothelial dysfunction and thrombosis; neuronal factors, including the susceptibility to cerebral ischaemia and inflammation, and cardiac factors, such as atrial fibrillation. Angiotensin II, acting via the AT1 receptor, plays a pivotal role in the development of these. There is now significant evidence that antihypertensive agents that block the actions of angiotensin II may also provide protection against primary and recurrent stroke through mechanisms independent of their blood pressure lowering effects.
