Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis - Full Text View

Purpose

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.

Condition	Intervention	Phase
Stroke Stenosis	Drug: Abciximab	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	Abciximab Versus Aspirin for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic >50% Carotid Stenosis: A Pilot Study (ASTERICS)

Resource links provided by NLM:

Drug Information available for: Abciximab

U.S. FDA Resources

Further study details as provided by University of Zurich:

Primary Outcome Measures:

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 Outcome Measures:

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.


Estimated Enrollment:	100
Study Start Date:	April 2004
Study Completion Date:	May 2005

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Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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).

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00126139

Locations


Switzerland
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

Sponsors and Collaborators

University of Zurich

Schweizerische Herzstiftung

Eli Lilly and Company

Investigators


Study Chair:	Ralf W. Baumgartner, MD	University Hospital of Zurich, Department of Neurology, Switzerland

More Information


ClinicalTrials.gov Identifier:	NCT00126139 History of Changes
Other Study ID Numbers:	E-046/2001
Study First Received:	July 29, 2005
Last Updated:	May 1, 2007
Health Authority:	Switzerland: Swissmedic

Keywords provided by University of Zurich:


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

Additional relevant MeSH terms:


Stroke Constriction, Pathologic Recurrence Carotid Stenosis Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases Vascular Diseases Cardiovascular Diseases Pathological Conditions, Anatomical	Disease Attributes Pathologic Processes Carotid Artery Diseases Arterial Occlusive Diseases Abciximab Antibodies, Monoclonal Immunoglobulin Fab Fragments Anticoagulants Platelet Aggregation Inhibitors Immunologic Factors Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2016