Status:
TERMINATED
Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis
Lead Sponsor:
University of Zurich
Collaborating Sponsors:
Schweizerische Herzstiftung
Eli Lilly and Company
Conditions:
Stroke
Stenosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Detailed Description
Prospective randomized trials have shown that carotid endarterectomy (CEA) is beneficial for stroke prevention in symptomatic severe or moderate stenoses of the carotid artery. Medical treatment and t...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
End Date :
May 1 2005
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT00126139
Start Date
April 1 2004
End Date
May 1 2005
Last Update
May 3 2007
Active Locations (5)
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1
University of Basel, Department of Neurology
Basel, Switzerland, 4031
2
University of Bern, Department of Neurology
Bern, Switzerland, 3010
3
University of Geneva, Department of Neurology
Geneva, Switzerland, 1211
4
University of Lausanne, Department of Neurology
Lausanne, Switzerland, 1011