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Published Online
on December 8, 2008

Stroke. 2008
Published online before print December 8, 2008, doi: 10.1161/STROKEAHA.108.526947
A more recent version of this article appeared on March 1, 2009
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Submitted on May 26, 2008
Accepted on July 30, 2008

Challenges of Designing Trials for the Primary Prevention of Stroke

Philip B. Gorelick MD, MPH*

From the Center for Stroke Research, Department of Neurology and Rehabilitation, University of Illinois College of Medicine at Chicago, Chicago, Ill, and Alexian Brothers Hospital Network.

* To whom correspondence should be addressed. E-mail: pgorelic{at}uic.edu.

Background and Purpose—Prevention of a first stroke is an important strategy to reduce morbidity and mortality associated with cerebrovascular disease. In this discussion, we review challenges to development of clinical trials for prevention of a first stroke.

Summary of Review—We discuss prevention of first stroke in the context of clinical trial design in the ARRIVE trial and a primary prevention trial in development for the elderly.

Conclusions—Stroke is an important outcome in cerebrovascular disease trials in the elderly, but it may be trumped by coronary heart disease as a more common end point.


Key words: clinical trials • primary prevention • stroke