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

Citation
Hp. Adams et al., Abciximab in acute ischemic stroke - A randomized, double-blind, placebo-controlled, dose-escalation study, STROKE, 31(3), 2000, pp. 601-609
Citations number
30
Language
INGLESE
art.tipo
Article
Categorie Soggetti
Neurology,"Cardiovascular & Hematology Research
Journal title
STROKE
ISSN journal
0039-2499 → ACNP
Volume
31
Issue
3
Year of publication
2000
Pages
601 - 609
Database
ISI
SICI code
0039-2499(200003)31:3<601:AIAIS->2.0.ZU;2-R
Abstract
Background and Purpose-Abciximab is a potent parenterally administered plat elet 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 st roke. 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-e scalation trial. Seventy-four eligible and consenting patients presenting w ithin 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 h ours after the completion:of study agent administration to monitor for blee ding 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 abc iximab patients (7%) and in 1 of 20 placebo patients (5%). Six additional a bciximab patients had asymptomatic hemorrhagic lesions detected by unschedu led 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 m inimal residual disability (Barthel Index greater than or equal to 95 or mo dified Rankin scale less than or equal to 1) among abciximab patients compa red with those who received placebo. Conclusions-Abciximab appears to be safe when administered up-to 24 hours a fter stroke onset, and it might improve functional outcome.