Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial.

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.

• Authors: Abciximab Emergent Stroke Treatment Trial (AbESTT) Investigators
• Journal: Stroke (Stroke) Vol. 36 Issue 4 Pg. 880-90 (Apr 2005) ISSN: 1524-4628 [Electronic] United States
• PMID: 15731473 (Publication Type: Clinical Trial, Clinical Trial, Phase II, Journal Article, Randomized Controlled Trial)

Chemical References

• Antibodies, Monoclonal
• Immunoglobulin Fab Fragments
• Placebos
• Platelet Aggregation Inhibitors
• Abciximab

Topics

• Abciximab
• Acute Disease
• Aged
• Antibodies, Monoclonal (adverse effects, therapeutic use)
• Brain (pathology)
• Brain Ischemia (drug therapy)
• Dose-Response Relationship, Drug
• Double-Blind Method
• Emergency Treatment
• Female
• Humans
• Immunoglobulin Fab Fragments (adverse effects, therapeutic use)
• Male
• Middle Aged
• Odds Ratio
• Placebos
• Platelet Aggregation Inhibitors (therapeutic use)
• Regression Analysis
• Stroke (drug therapy)
• Time Factors
• Treatment Outcome