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(Stroke. 2009;40:S82.)
© 2009 American Heart Association, Inc.

Prevention 2: High-Risk Populations

Challenges of Designing Trials for the Primary Prevention of Stroke

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.

Correspondence to Philip B. Gorelick, MD, MPH, Professor and Head, Director, Center for Stroke Research, Department of Neurology and Rehabilitation, University of Illinois College of Medicine at Chicago, 912 S Wood Street, Room 855N, Chicago, IL 60612. 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