Abciximab in acute XXXX . A randomized, double-blind, placebo-controlled, dose-escalation study.

@entity1 @entity717 @entity932 @entity64 @entity548 @entity453 @entity385
BACKGROUND AND PURPOSE: Abciximab is a potent parenterally administered platelet glycoprotein IIb/IIIa antagonist. Because this agent has been shown to improve outcomes in @entity453 , there is interest to evaluate whether it could improve cerebral perfusion and outcomes after @entity385 . This study was designed to evaluate the safety of abciximab in acute @entity385 and to obtain pilot efficacy data. METHODS: We conducted a randomized, double-blind, placebo-controlled, dose-escalation trial. Seventy-four eligible and consenting @entity1 presenting within 24 hours after @entity385 onset at 38 study sites were randomly allocated to receive either an escalating dose of abciximab (54 @entity1 ) or placebo (20 @entity1 ) in a ratio of 3:1. We studied 4 escalating doses of abciximab. @entity1 underwent a scheduled follow-up head CT scan 24 to 36 hours after the completion of study agent administration to monitor for @entity548 complications and were evaluated through 3 months. RESULTS: There were no cases of major @entity932 . Asymptomatic parenchymal hemorrhages were detected on post-study agent CT in 4 of 54 abciximab @entity1 (7%) and in 1 of 20 placebo @entity1 (5%). Six additional abciximab @entity1 had asymptomatic @entity548 detected by unscheduled brain imaging during their follow-up period. Nine of 11 @entity1 with asymptomatic @entity548 had a baseline National Institutes of Health Stroke Scale score >14. At 3 months, there was a trend toward a higher rate of minimal @entity717 (Barthel Index > or =95 or modified Rankin scale < or =1) among abciximab @entity1 compared with those who received placebo. CONCLUSIONS: Abciximab appears to be safe when administered up to 24 hours after @entity64 onset, and it might improve functional outcome.
