Journal article
Emergency administration of abciximab for treatment of patients with acute ischemic stroke : Results of a randomized phase 2 trial
Stroke (1970), Vol.36(4), pp.880-890
2005
DOI: 10.1161/01.STR.0000157668.39374.56
PMID: 15731473
Abstract
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 microg/kg per minute (maximum 10 microg/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.
Details
- Title: Subtitle
- Emergency administration of abciximab for treatment of patients with acute ischemic stroke : Results of a randomized phase 2 trial
- Creators
- Abciximab Emergent Stroke Treatment Trial (AbESTT) Investigators
- Contributors
- Harold P Adams Jr (Contributor) - University of Iowa, Neurology
- Resource Type
- Journal article
- Publication Details
- Stroke (1970), Vol.36(4), pp.880-890
- Publisher
- Lippincott Williams & Wilkins; Hagerstown, MD
- DOI
- 10.1161/01.STR.0000157668.39374.56
- PMID
- 15731473
- ISSN
- 0039-2499
- eISSN
- 1524-4628
- Language
- English
- Date published
- 2005
- Academic Unit
- Neurology; Iowa Neuroscience Institute
- Record Identifier
- 9984018905702771
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