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Abciximab Emergent Stroke Treatment Trial - AbESTT
Description:
The goal of the trial was to evaluate the safety and efficacy of treatment with abciximab compared with placebo among patients with acute ischemic stroke.
Study Design
Study Design:
Patients Screened: 5342
Patients Enrolled: 400
Mean Follow Up: 3 months
Mean Patient Age: Mean age 67 years
Female: 44
Patient Populations:
Age > 18 years with acute ischemic stroke that could be treated within 6 hours of onset of symptoms and baseline NIHSS score 4 to <23.
Exclusions:
Disabled prior to stroke; received rtPA in prior 3 hours for stroke; persistent hypertension that cannot be controlled; coagulation abnormality on baseline tests; recent major hemorrhage, surgery, or trauma; concomitant severe medical illness; need for contraindicated surgical or medical therapies.
Primary Endpoints:
Safety: Symptomatic intracranial hemorrhage (ICH) within 5 days or hospital discharge
Efficacy: Modified Rankin scale score (mRS) score at 3 months
Drug/Procedures Used:
Patients were randomized in a double-blind manner to treatment with abciximab (0.25 mg/kg bolus and 12 hour infusion of 0.125 µg/kg/min; n=200) or placebo (n=200). CT study was repeated at 36-48 hours after study drug infusion. Other antithrombotic agents were not to be used until after study drug discontinuation and after the CT was performed.
Principal Findings:
The mean time from stroke until treatment with randomized therapy was 5 hours. Mean NIHSS score was 10. Cause of stroke was cardioembolic in 25% of patients, large artery atherosclerosis in 16%, and small vessel occlusion in 12%.
The primary safety endpoint of symptomatic ICH within 5 days or hospital discharge occurred in 3.6% of the abciximab group and 1% of the placebo group (odds ratio [OR] 3.7, p=0.09). TIMI major or minor bleeding occurred in 8 patients in the abciximab group and 3 in the placebo group. Thrombocytopenia during the first 5 days was reported in 3 patients in the abciximab group and 1 in the placebo group. Mortality at 5 days occurred in 8 abciximab patients and 2 placebo patients.
The primary efficacy endpoint of mRS scores at 3 months did not differ between treatment group (OR 1.20, p=0.33). mRS scores of 0 or 1 were present in 48.5% of the abciximab group and 40.0% of the placebo group. NIHSS score of 0 or 1 at 3 months also occurred more frequently in the abciximab group (46% vs 34%, OR 1.65, p=0.01).
Interpretation:
Among patients with acute ischemic stroke, treatment with abciximab was not associated with a significant difference in the modified Rankin scale score at 3 months but was associated with a trend toward an increase in ICH within 5 days compared with placebo.
Standard treatment for acute ischemic stroke is use of recombinant tissue plasminogen activator (rtPA). However, rtPA must be administered within 3 hours of the onset of the stroke, which limits its use. Based on the findings of this phase 2 trial, the larger AbESTT II trial was undertaken. The AbESTT II trial was discontinued early due to a high rate of ICH.
References:
Abciximab Emergent Stroke Treatment Trial (AbESTT) Investigators. Emergency administration of abciximab for treatment of patients with acute ischemic stroke: results of a randomized phase 2 trial. Stroke 2005;36:880-90.
Keywords: Stroke, Atherosclerosis, Platelet Aggregation Inhibitors, Cerebrovascular Disorders, Fibrinolytic Agents, Immunoglobulin Fab Fragments, Tissue Plasminogen Activator, Thrombocytopenia
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