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

Publication ,  Journal Article
Abciximab in Ischemic Stroke Investigators,
Published in: Stroke
March 2000

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 11 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 > or =95 or modified Rankin scale < or =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.

Duke Scholars

Published In

Stroke

DOI

ISSN

0039-2499

Publication Date

March 2000

Volume

31

Issue

3

Start / End Page

601 / 609

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Safety
  • Radiography
  • Platelet Aggregation Inhibitors
  • Placebos
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Length of Stay
 

Citation

APA
Chicago
ICMJE
MLA
NLM
Abciximab in Ischemic Stroke Investigators, . (2000). Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study. Stroke, 31(3), 601–609. https://doi.org/10.1161/01.str.31.3.601
Abciximab in Ischemic Stroke Investigators, N. J. “Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study.Stroke 31, no. 3 (March 2000): 601–9. https://doi.org/10.1161/01.str.31.3.601.
Abciximab in Ischemic Stroke Investigators. Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study. Stroke. 2000 Mar;31(3):601–9.
Abciximab in Ischemic Stroke Investigators, N. J. “Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study.Stroke, vol. 31, no. 3, Mar. 2000, pp. 601–09. Pubmed, doi:10.1161/01.str.31.3.601.
Abciximab in Ischemic Stroke Investigators. Abciximab in acute ischemic stroke. A randomized, double-blind, placebo-controlled, dose-escalation study. Stroke. 2000 Mar;31(3):601–609.

Published In

Stroke

DOI

ISSN

0039-2499

Publication Date

March 2000

Volume

31

Issue

3

Start / End Page

601 / 609

Location

United States

Related Subject Headings

  • Treatment Outcome
  • Stroke
  • Safety
  • Radiography
  • Platelet Aggregation Inhibitors
  • Placebos
  • Neurology & Neurosurgery
  • Middle Aged
  • Male
  • Length of Stay