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

NCT00126139 | Terminated Phase 3 DMC

• 1 other identifier: E-046/2001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 5

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 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.

Conditions

Stroke; Stenosis

Keywords

stroke, ischemic; stenosis, internal carotid artery; Acute ischemic stroke; Stenosis of extracranial internal carotid artery

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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.

Interventions

Abciximab DRUG

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Zurich: lead
• Schweizerische Herzstiftung: collaborator
• Eli Lilly and Company: collaborator

Study Sites (5)

University of Basel, Department of Neurology

Basel, 4031, Switzerland

Location

University of Bern, Department of Neurology

Bern, 3010, Switzerland

Location

University of Geneva, Department of Neurology

Geneva, 1211, Switzerland

Location

University of Lausanne, Department of Neurology

Lausanne, 1011, Switzerland

Location

University of Zurich, Department of Neurology

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Stroke; Constriction, Pathologic; Ischemic Stroke; Carotid Stenosis

Interventions

Abciximab

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Carotid Artery Diseases; Arterial Occlusive Diseases

Intervention Hierarchy (Ancestors)

Immunoglobulin Fab Fragments; Immunoglobulin Fragments; Peptide Fragments; Peptides; Amino Acids, Peptides, and Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Serum Globulins; Globulins

Study Officials

• Ralf W. Baumgartner, MD

  University Hospital of Zurich, Department of Neurology, Switzerland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 29, 2005
• First Posted: August 2, 2005
• Study Start: April 1, 2004
• Study Completion: May 1, 2005
• Last Updated: May 3, 2007

Record last verified: 2007-05

Locations

CH (5)