Medizinische Universität Graz Austria/Österreich - Forschungsportal - Medical University of Graz
Gewählte Publikation:
SHR Neuro Krebs Kardio Lipid Stoffw Microb
Abciximab Emergent Stroke Treatment Trial (AbESTT) Investigators.
Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial.
Stroke. 2005; 36(4):880-890
Doi: 10.1161/01.STR.0000157668.39374.56
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- Co-Autor*innen der Med Uni Graz
- Fazekas Franz
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- 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.
- Find related publications in this database (using NLM MeSH Indexing)
- Acute Disease -
- Aged -
- Antibodies, Monoclonal - adverse effects
- Brain - pathology
- Brain Ischemia - drug therapy
- Cerebrovascular Accident - drug therapy
- Dose-Response Relationship, Drug - drug therapy
- Double-Blind Method - drug therapy
- Emergency Treatment - drug therapy
- Female - drug therapy
- Humans - drug therapy
- Immunoglobulin Fab Fragments - adverse effects
- Male - adverse effects
- Middle Aged - adverse effects
- Odds Ratio - adverse effects
- Placebos - adverse effects
- Platelet Aggregation Inhibitors - therapeutic use
- Regression Analysis - therapeutic use
- Time Factors - therapeutic use
- Treatment Outcome - therapeutic use
- Find related publications in this database (Keywords)
- antiplatelet agents
- emergency medical treatment
- stroke