Intravenous Ancrod for Treatment of Acute Ischemic Stroke: The STAT Study: A Randomized Controlled Trial
2000
ContextApproved treatment options for acute ischemic stroke in the United States
and Canada are limited at present to intravenous tissue-type plasminogen activator,
but bleeding complications, including intracranial hemorrhage, are a recognized
complication.ObjectiveTo evaluate the efficacy and safety of the defibrinogenating agent ancrod
in patients with acute ischemic stroke.DesignThe Stroke Treatment with Ancrod Trial (STAT), a randomized, parallel-group,
double-blind, placebo-controlled trial conducted between August 1993 and January
1998.SettingForty-eight centers, primarily community hospitals, in the United States
and Canada.PatientsA total of 500 patients with an acute or progressing ischemic neurological
deficit were enrolled and included in the intent-to-treat analysis.InterventionsPatients were randomly assigned to receive ancrod (n=248) or placebo
(n=252) as a continuous 72-hour intravenous infusion beginning within 3 hours
of stroke onset, followed by infusions lasting approximately 1 hour at 96
and 120 hours. The ancrod regimen was designed to decrease plasma fibrinogen
levels to 1.18 to 2.03 µmol/L.Main Outcome MeasuresThe primary efficacy end point was functional status, with favorable
functional status defined as survival to day 90 with a Barthel Index of 95
or more or at least the prestroke value, compared by treatment group. Primary
safety variables included symptomatic intracranial hemorrhage and mortality.ResultsFavorable functional status was achieved by more patients in the ancrod
group (42.2%) than in the placebo group (34.4%; P=.04)
by the prespecified covariate-adjusted analysis. Mortality was not different
between treatment groups (at 90 days, 25.4% for the ancrod group and 23% for
the placebo group; P=.62), and the proportion of
severely disabled patients was less in the ancrod group than in the placebo
group (11.8% vs 19.8%; P=.01). The favorable functional
status observed with ancrod vs placebo was consistent in all subgroups defined
for age, stroke severity, sex, prestroke disability, and time to treatment
(≤3 or >3 hours after stroke onset). There was a trend toward more symptomatic
intracranial hemorrhages in the ancrod group vs placebo (5.2% vs 2.0%; P=.06), as well as a significant increase in asymptomatic
intracranial hemorrhages (19.0% vs 10.7%; P=.01).ConclusionIn this study, ancrod had a favorable benefit-risk profile for patients
with acute ischemic stroke.
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