Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis

• Status: Terminated
• Trial end date: 2005-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Zurich
• Collaborators: Eli Lilly and Company; Schweizerische Herzstiftung
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

• Age at least 18 years.

• Presence of symptoms of an ischemic stroke with a baseline National Institutes of Health Stroke Scale (NIHSS) scale of one up to 20 or due to an ipsilateral atherosclerotic >50% stenosis of the extracranial internal carotid artery (ICA) as shown by ultrasonography.

• Latency between the onset of stroke symptoms and intended administration of the study drugs is not more than 24 hours.

• Latency between the intended administration of the study drugs and intended carotid endarterectomy is at least three days.

Exclusion Criteria:

• Documented peptic ulcer disease within the preceding 30 days.

• Septicemia or severe localized infection.

• Severe illness (active cancer or significant liver or renal disease) or disability.

• Alcohol or illicit drug abuse.

• Pregnancy.

• Need for chronic anticoagulant therapy (e.g. atrial fibrillation, deep venous thrombosis).

• Need for long-term daily nonsteroidal antiinflammatory drugs.

• Contraindications for platelet therapy such as severe bleeding disorder within the past three months prior to randomization (coagulopathy, platelet disorder including history of heparin-induced thrombopenia, hemorrhage) or significant retinopathy with hemorrhages and exudates.

• Hypersensitivity to abciximab, murine monoclonal antibodies or aspirin.

• Any preexisting intracranial neurological disease such as tumor or multiple sclerosis.

• Intracranial or intraspinal operation or trauma or lumbar puncture within the last 2 months.

• Cardiac lesions likely to cause cardioembolism.

• Suspicion of or established non-atherosclerotic carotid artery disease such as dissection or vasculitis (Takayasu disease, giant cell arteritis, significant collagen vascular disease, systemic necrotizing vasculitis, granulomatous angiitis of the nervous system).

• Participation in another acute stroke trial investigating drugs other than abciximab.

• Treatment for the present stroke with tissue plasminogen activator, urokinase or ancrod.

• ICH, aneurysm, vascular malformation or arteriovenous fistula or sinovenous thrombosis of the brain.

• Brain infarct involving the whole territory of the middle cerebral artery (MCA).

• Stupor or coma.

• Uncontrolled hypertension (systolic pressure >200 mmHg and/or diastolic pressure >110 mmHg).

• No informed consent.

• Contraindication to undergo magnetic resonance (MR) imaging (eg pacemaker).