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Warfarin-Aspirin Symptomatic
Intracranial Disease Study
for Stroke
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If you are a physician and want to know more about how to refer patients
to the WASID study contact the principal
investigator nearest you. Other
questions may be sent to the study coordinator in your area.
Aspirin provided by Bayer: http://www.bayer.com/
Warfarin provided by DuPont: http://www.dupont.com/
Principal Investigator
Marc I. Chimowitz, MBChB
Department of Neurology
School of Medicine
Emory University
Atlanta, GA 30322
Study Design
The main objective of this trial is to compare warfarin (target INR 2-3)
with aspirin (1300 mg/day) for preventing stroke (ischemic and
hemorrhagic) and vascular death in patients with symptomatic stenosis
of a major intracranial artery. This is a prospective, randomized
double-blind, multi-center trial. The sample size required will be 403
patients per group
Study Criteria
Patients with transient ischemic attack TIA or stroke caused by
angiographically proven stenosis of greater than or equal to 50
percent of a major intracranial artery will be randomized to warfarin
or aspirin therapy. See
inclusion and exclusion criteria
Endpoints
The primary analysis will compare the rates of stroke (ischemic and
hemorrhagic) and vascular death in the two treatment groups.
Secondary analyses will compare the two treatment groups with
respect to rates of i) all vascular deaths and disabling stroke, ii) all
stroke (ischemic and hemorrhagic), iii) fatal and nonfatal ischemic
stroke, iv) all ischemic stroke, myocardial infarction and vascular
death, v) all major systemic and any intracranial hemorrhage, vi) all
ischemic stroke in the territory of the stenotic intracranial artery.
A
secondary analysis of the patients in the "best medical therapy group",
will identify the rate of ischemic stroke in the territory of the
stenotic
intracranial artery. Predictions are that the ischemic stroke rate
will be
<3% per year in patients with 50%-69% intracranial stenosis and >
6%
per year in patients with 70%-99% intracranial stenosis.
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