AbESTT-II
A Study of Effectiveness and Safety of Abciximab in Patients With Acute Ischemic Stroke
|
Status:
This study has been terminated. Based on the data and observed benefit-risk profile, the trial's independent oversight committee recommended that enrollment not resume.
Purpose:
To determine the effectiveness of abciximab in the treatment of acute ischemic stroke.
Interventions:
Abciximab
Intravenous platelet aggregation inhibitor, monoclonal antibody directed against the platelet glycoprotein GP IIb-IIIa receptor
|
Location(s):
International
Year Started:
2003
Year Finished:
2005
Design:
Interventional, Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study.
Inclusion Criteria
Patients with diagnosis of acute ischemic stroke with onset within 5 hours and 30 minutes before randomization and planned treatment initiation within 6 hours of onset
After 600 patients are enrolled in previous criteria, the new criteria for enrollment will be, patients with diagnosis of acute ischemic stroke with onset within 4 hours and 30 minutes before randomization and planned treatment initiation within 5 hours of onset.
Exclusion Criteria
Patients who had participation in another study with an investigational drug or device within the last 30 days, prior participation in the present study, or planned participation in another trial; patients with symptoms suggestive of subarachnoid hemorrhage; female patients known to be pregnant, lactating, or having a positive or indeterminate pregnancy test; patients with neurological deficit that has led to stupor or coma; patients with minor stroke.
Patient Involvement:
Patients will receive either Abciximab: 0.25 mg/kg bolus (to a maximum of 30 mg) followed by a 0.125 µg/kg/min infusion (to a maximum of 10 µg/min) for 12 hours or a bolus of placebo followed by infusion for 12 hours. Patient monitoring will consist of laboratory tests, vital signs (such as blood pressure), physical examinations and the occurrence and severity of adverse events as well as other study specific procedures at baseline, discharge, 5 days after discharge and 3 months.
Primary Outcome:
The proportion of modified Rankin Scale responders at 3 months in the primary population.
Secondary Outcome:
Proportion of patients with neurological recovery and all-cause mortality at 3 months in the primary population; fatal intracranial-, nonfatal symptomatic parenchymal-, or other symptomatic intracranial hemorrhages though discharge at 5th day and 3 months.
Results:
The trial was terminated prematurely after 808 patients in all cohorts were enrolled by recommendation of an independent safety and efficacy monitoring board due to an unfavorable benefit-risk profile. At 3 months, approximately 33% of patients assigned placebo (72/218) and 32% of patients assigned abciximab (71/221; P=0.944) in the primary cohort were judged to have a favorable response to treatment. The distributions of outcomes on the modified Rankin Scale were similar between the treated and control groups. Within 5 days of enrollment, approximately 5.5% of abciximab-treated and 0.5% of placebo-treated patients in the primary cohort had symptomatic or fatal intracranial hemorrhage (P=0.002). The trial also did not demonstrate an improvement in outcomes with abciximab among patients in the companion and wake-up cohorts. Although the number of patients was small, an increased rate of hemorrhage was noted within 5 days among patients in the wake-up population who received abciximab (13.6% versus 5% for placebo). This trial did not demonstrate either safety or efficacy of intravenous administration of abciximab for the treatment of patients with acute ischemic stroke regardless of end point or population studied. There was an increased rate of symptomatic or fatal intracranial hemorrhage in the primary and wake-up cohorts.
Source of Information:
ClinicalTrials.gov
2008 article in Stroke
|
|
Web Links and Publications:
|
|
This information last updated on: 7/16/2008
Reviewed on: 07/16/2008.
|
Trials
Directories