Patients suffering from symptomatic carotid artery stenosis, transient ischemic attacks (TIAs), amaurosis fugax or stroke receive either Revacept (single dose) plus antiplatelet monotherapy or monotherapy alone. Patients receive a single dose of trial medication by intravenous infusion for 20 minutes. Patients are followed up one and three days after treatment, at 3 months and by a telephone interview at 12 months.
Patients had a more than 50% carotid artery stenosis according to ECST and suffered from ischemic stroke, transitory ischemic attack or intermittent blindness (amaurosis fugax) within the last 30 days. All patients were on standard medication with aspirin or clopidogrel and received heparin for thrombosis prophylaxis. Carotid endarterectomy (CEA), carotid stenting (CAS) or best medical therapy for treatment of the carotid stenosis and prevention of secondary thrombo-emboli was performed according to guidelines. Additional treatment with Revacept or placebo was done on top of the standard therapy. Therefore the control group receiving placebo was already on the standard medical therapy for patients with symptomatic carotid stenosis and received also the guideline conform interventions CEA, CAS or best medical therapy. Secondary prophylaxis of thrombo-embolic ischemic events by Revacept should be investigated. Therefore microemboli were detected by transcranial Doppler and ischemic brain lesions were investigated by diffusion weighted imaging magnetic resonance imaging (DWI-MRI) scan as exploratory endpoints. Moreover clinical endpoints such as stroke, TIA, myocardial infarction, coronary intervention and death were investigated at 1 week, 3 months and 12 months follow-up. Safety was closely monitored with emphasis on bleeding complications as bleeding is the most dreaded complication of anti-thrombotic agents especially in patients with cerebral strokes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
Site 01: Department of Neurology, TU Munich
Munich, Bavaria, Germany
Site 08: Universitätsklinikum Essen, Klinik für Neurologie
Essen, Germany
Site 11: Universitätsklinikum Hamburg Eppendorf
Hamburg, Germany
New DWI Lesion(s)
The number of new diffusion weighted imaging (DWI) lesion(s) reported. (1 day after intervention compared to baseline).
Time frame: 1 day post intervention
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Site 07: Medizinische Hochschule Hannover, Klinik für Neurologie
Hanover, Germany
Site 12: Universitätsklinikum Leipzig AöR
Leipzig, Germany
Site 09: Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie
Mainz, Germany
Site 04: Universitätsklinikum Tübingen, Klinik für Allgemeine Neurologie
Tübingen, Germany
Site 06: Universitätsklinikum Ulm, Abteilung für Neurologie
Ulm, Germany
Site 23 - University Hospital Coventry NHS Trust
Coventry, United Kingdom
Site 26 - University College London Hospital
London, United Kingdom
...and 2 more locations