Background and Purpose-Abciximab is a potent parenterally administered plat
elet glycoprotein IIb/IIIa antagonist, Because:this agent has been shown to
improve outcomes in coronary artery disease, there is interest to evaluate
whether it could improve cerebral perfusion and outcomes after ischemic st
roke. This study was designed to evaluate the safety of abciximab in acute
ischemic stroke and to obtain pilot efficacy data.
Methods-We conducted a randomized, double-blind, placebo-controlled, dose-e
scalation trial. Seventy-four eligible and consenting patients presenting w
ithin 24 hours after ischemic stroke onset at 38 study sites were randomly
allocated to receive either an escalating dose of abciximab (54 patients)or
placebo (20 patients) in a ratio of 3:1, We studied 4 escalating doses of
abciximab. Patients underwent a scheduled follow-up head CT scan 24 to 36 h
ours after the completion:of study agent administration to monitor for blee
ding complications and were evaluated through 3 months.
Results-There were no cases of major intracranial hemorrhage, Asymptomatic
parenchymal hemorrhages were detected on post-study agent CT in 4 of 54 abc
iximab patients (7%) and in 1 of 20 placebo patients (5%). Six additional a
bciximab patients had asymptomatic hemorrhagic lesions detected by unschedu
led brain imaging during their follow-up period. Nine of 1 1 patients with
asymptomatic hemorrhage had a:baseline National Institutes of Health Stroke
Scale-score > 14. At 3 months, there was a trend toward a higher rate of m
inimal residual disability (Barthel Index greater than or equal to 95 or mo
dified Rankin scale less than or equal to 1) among abciximab patients compa
red with those who received placebo.
Conclusions-Abciximab appears to be safe when administered up-to 24 hours a
fter stroke onset, and it might improve functional outcome.