Challenges of designing trials for the primary prevention of stroke

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.