Stroke, Vol 20, 844-849, Copyright © 1989 by American Heart Association
This report summarizes the study design and organization of a multicenter,
randomized trial of carotid endarterectomy for the treatment of
asymptomatic carotid stenosis. The Asymptomatic Carotid Atherosclerosis
Study will determine whether the addition of carotid endarterectomy to
aspirin plus risk factor modifications affects the incidence of ipsilateral
transient ischemic attack, amaurosis fugax, and retinal and cerebral
infarction in patients with asymptomatic hemodynamically significant
carotid stenosis in at least one artery. Power calculations are based on
assumptions of alpha = 0.05 (two-sided test) with annual event rate 3%
transient ischemic attack and 1% cerebral infarction per year. The study
has 90% power for detection of a 25% difference in events in a 5-year
study. Two continuous validation programs are in use: a Doppler/angiogram
correlation study for each Doppler instrument used in screening potential
candidates and a transient ischemic attack/stroke questionnaire/validation
study for verification of end points. Quality assurance is a major
component in study design.
ARTICLES
Study design for randomized prospective trial of carotid endarterectomy for asymptomatic atherosclerosis. The Asymptomatic Carotid Atherosclerosis Study Group
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