Abciximab in acute ischemic stroke - A randomized, double-blind, placebo-controlled, dose-escalation study

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 1 1 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 greater than or equal to 95 or modified Rankin scale less than or equal to 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.