Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis
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ClinicalTrials.gov Identifier: NCT00126139 |
Recruitment Status :
Terminated
(Higher hemorrhage rates of Abciximab in ABESST II trial)
First Posted : August 2, 2005
Last Update Posted : May 3, 2007
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Stroke Stenosis | Drug: Abciximab | Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Single Group Assignment |
Masking: | Double |
Primary Purpose: | Treatment |
Official Title: | Abciximab Versus Aspirin for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic >50% Carotid Stenosis: A Pilot Study (ASTERICS) |
Study Start Date : | April 2004 |
Actual Study Completion Date : | May 2005 |

- 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
- 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.

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00126139
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 |
Study Chair: | Ralf W. Baumgartner, MD | University Hospital of Zurich, Department of Neurology, Switzerland |
ClinicalTrials.gov Identifier: | NCT00126139 |
Other Study ID Numbers: |
E-046/2001 |
First Posted: | August 2, 2005 Key Record Dates |
Last Update Posted: | May 3, 2007 |
Last Verified: | May 2007 |
stroke, ischemic stenosis, internal carotid artery Acute ischemic stroke Stenosis of extracranial internal carotid artery |
Stroke Carotid Stenosis Constriction, Pathologic Recurrence 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 Anticoagulants Platelet Aggregation Inhibitors |