(Stroke. 2000;31:601.)
© 2000 American Heart Association, Inc.
Original Contributions |
Abciximab in Acute Ischemic Stroke
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study
From the Department of Neurology, University of Iowa, Iowa City, and the Department of Neurology, CHUV, Lausanne, Switzerland.
Correspondence to H.P. Adams, Jr, MD, Department of Neurology, University of Iowa, Iowa City, IA 52242-1053. E-mail julien.bogousslavsky{at}chuv.hospvd.ch
Background and Purpose—Abciximab is a potent parenterally administered platelet 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 stroke. 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-escalation trial. Seventy-four eligible and consenting patients presenting within 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 hours after the completion of study agent administration to monitor for bleeding 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
abciximab patients (7%) and in 1 of 20 placebo patients (5%). Six
additional abciximab patients had asymptomatic hemorrhagic
lesions detected by unscheduled brain imaging during their follow-up
period. Nine of 11 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 minimal residual disability (Barthel Index 
95 or modified Rankin
scale 
1) among abciximab patients compared with those who received
placebo.
Conclusions—Abciximab appears to be safe when administered up to 24 hours after stroke onset, and it might improve functional outcome.
Key Words: platelet aggregation inhibitors • randomized controlled trials • stroke, ischemic
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