Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis
The purpose of the present prospective, randomized, double-blind, double dummy controlled multicenter pilot study is to investigate whether abciximab, compared with aspirin, is able to reduce the rate of recurrent ischemic strokes before and during carotid endarterectomy [CEA] (primary endpoints); and the degree of carotid stenosis, number of microembolic signal (MES) counts, number of ischemic infarcts at diffusion weighted imaging (DWI) and amount of intraluminal thrombus at pathological examination (secondary endpoints) in patients with ischemic stroke due to a >50% carotid stenosis who will undergo CEA.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Primary Purpose: Treatment
|Official Title:||Abciximab Versus Aspirin for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic >50% Carotid Stenosis: A Pilot Study (ASTERICS)|
- Whether abciximab compared with aspirin reduces the rate of recurrent ischemic strokes in territory of symptomatic carotid artery during administration of study drug, preoperative period or carotid endarterectomy
- Reduction of the degree of carotid stenosis at ultrasound studies performed 48-72 h after compared to 24 h prior to iv administration of the study agents.
- Reduction of MES counts measured 48-72 h after compared to 24 h prior to the administration of the iv study drugs.
- Difference of number of acute ischemic infarct on DWI assessed 48-72 h after compared to 24 h prior to the administration of the iv study drugs.
- Symptomatic ICH and asymptomatic hemorrhagic transformation occurring during or within 48-72 h after the administration of the iv study drugs.
- Size of plaque/intraplaque thrombus and intraplaque hemorrhage will be assessed at pathological examination of endarterectomy specimen after CEA.
- Clinical outcome at 90 days will be assessed using the NIHSS and the mRS.
|Study Start Date:||April 2004|
|Study Completion Date:||May 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00126139
|University of Basel, Department of Neurology|
|Basel, Switzerland, 4031|
|University of Bern, Department of Neurology|
|Bern, Switzerland, 3010|
|University of Geneva, Department of Neurology|
|Geneva, Switzerland, 1211|
|University of Lausanne, Department of Neurology|
|Lausanne, Switzerland, 1011|
|University of Zurich, Department of Neurology|
|Zurich, Switzerland, 8091|
|Study Chair:||Ralf W. Baumgartner, MD||University Hospital of Zurich, Department of Neurology, Switzerland|