Published online before print February 24, 2005, doi: 10.1161/01.STR.0000157668.39374.56
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(Stroke. 2005;36:880.)
© 2005 American Heart Association, Inc.
Special Report |
Emergency Administration of Abciximab for Treatment of Patients With Acute Ischemic Stroke
Results of a Randomized Phase 2 Trial
Correspondence to Harold P. Adams Jr, MD, Department of Neurology, University of Iowa, 200 Hawkins Drive, Iowa City, IA 52242. E-mail harold-adams{at}uiowa.edu, or Werner Hacke, MD, PhD, Department of Neurology, University of Heidelberg, Im Neuenheimer Feld 400, D-69120 Heidelberg, Germany. E-mail werner_hacke{at}med.uni-heidelberg.de
Background and Purpose— Because of its success in treatment of acute cardiac ischemia, there is interest in the use of abciximab for treating patients with acute ischemic stroke. A previous dose-escalation study determined that abciximab could be given safely in a regimen of 0.25 mg/kg intravenous bolus followed by a 12-hour infusion at 0.125 µg/kg per minute (maximum 10 µg/min). This study was performed to obtain more information about the safety and potential efficacy of abciximab in patients with stroke.
Methods— An international randomized, double-blind, placebo-controlled phase 2 trial enrolled 400 patients within 6 hours of onset of ischemic stroke. The primary safety outcome was the rate of symptomatic hemorrhage that occurred during the first 5 days after stroke. The primary efficacy measure was the distribution of outcomes at 3 months after stroke using the modified Rankin Scale (mRS) based on an ordinal regression model of outcomes, adjusting for baseline severity of stroke, age, and interval from stroke.
Results— Symptomatic intracranial hemorrhage within 5 days was diagnosed in 7 of 195 (3.6%) patients treated with abciximab and 2 of 199 (1%) patients given placebo (odds ratio [OR], 3.7; P=0.09; 95% confidence interval [CI], 0.7 to 25.9). Asymptomatic hemorrhagic transformation was detected by brain imaging in 24 patients administered abciximab and 33 patients receiving placebo (OR, 0.74; P=0.25; 95% CI, 0.4 to 1.3). Treatment with abciximab showed a nonsignificant shift in favorable outcomes as measured by mRS scores at 3 months (OR, 1.20; P=0.33; 95% CI, 0.84 to 1.70).
Conclusions— Intravenously administered abciximab can be given to patients with a reasonable degree of safety. The trial also suggests that abciximab could improve outcomes at 3 months after stroke. A larger randomized, double-blind, placebo-controlled trial is necessary to test the efficacy of abciximab.
Key Words: antiplatelet agents • emergency medical treatment • stroke
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