Stroke Trials Registry

AbESTT
Abciximab in Emergent Stroke Treatment Trial

Principal Investigator
Harold P. Adams Jr., M.D.

PI Address
Department of Neurology, University of Iowa, Iowa City, IA
University of Iowa College of Medicine
Iowa City, Iowa

Contact Email
harold-adams@uiowa.edu

Sponsor

Trial Phase:	Phase II
Study Size Actual:	400
Centers Actual:	40
Max Time from onset:	6 Hours
Max Age:	90
Min Age:	18

Status:
Trial complete. Preliminary results presented in October of 2002, with final results presented in February of 2003. A phase III trial is planned.

Purpose:
To determine the safety of abciximab in acute stroke.

Interventions:

Abciximab
Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor

Location(s):
North America, Europe

Year Finished: 2002

Year Presented: 2002

Year Published: 2005

Design:
Randomized, double-blind, placebo-controlled trial.

Inclusion Criteria
Patients who present within 6 hours of ischemic stroke, who have a National Institute of Health Stroke Scale (NIHSS) score between 4 and 22, were eligible for this study.

Patient Involvement:
Patients randomized to abcixmab received a 0.25mcg/kg bolus followed by a 0.125mcg/kg/minute infusion for 12 hours.

Primary Outcome:
Fatal intracerebral hemorrhage (ICH), nonfatal symptomatic parenchymal hemorrhage, or other symptomatic ICH through discharge or day 5, if earlier.

Secondary Outcome:
Patient outcome was measured by the Modified Rankin Scale at 3 months.

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.

Comments:
Preliminary results:
Abciximab goup - 23.5% of patients achieved a 0 on the MRS at 90 days. 25% achieved a score of 1. 9% of patients died. Symptomatic ICH rate for this group was 3.6%, with an asymptomatic ICH rate of 12.3%.

Placebo group - 13.5% achieved a 0 on the MRS at 90 days. 26.5% achieved a score of 1. 12.5% of patients died. Symptomatic ICH rate for this group was 1.0%, with an asymptomatic ICH rate of 16.6%.

Source of Information:
Internet trial sites. Direct correspondence with trial coordinator. Presented at the 28th International Stroke Conference (February 2003). Stroke. 2003;34:252.

Web Links and Publications:

Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial.
Stroke 2005 Apr;36(4):880-90

This information last updated on: 10/19/2009

Reviewed on: 05/14/2008.

UID: 416