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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 February 2015
• Main ID: NCT00126139
• Date of registration: 29/07/2005
• Prospective Registration: No
• Primary sponsor: University of Zurich
• Public title: Abciximab for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic Carotid Stenosis
• Scientific title: Abciximab Versus Aspirin for Prevention of Stroke Recurrence Before Endarterectomy in Symptomatic >50% Carotid Stenosis: A Pilot Study (ASTERICS)
• Date of first enrolment: April 2004
• Target sample size: 100
• Recruitment status: Terminated
• URL: http://clinicaltrials.gov/show/NCT00126139
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Treatment
• Phase: Phase 3

Countries of recruitment

Switzerland

Contacts

• Name: Ralf W. Baumgartner, MD
• Affiliation: University Hospital of Zurich, Department of Neurology, Switzerland

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Stroke

Stenosis

Intervention(s)

Drug: Abciximab

Primary Outcome(s)

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(s)

Clinical outcome at 90 days will be assessed using the NIHSS and the mRS.

Size of plaque/intraplaque thrombus and intraplaque hemorrhage will be assessed at pathological examination of endarterectomy specimen after CEA.

Symptomatic ICH and asymptomatic hemorrhagic transformation occurring during or within 48-72 h after 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.

Reduction of MES counts measured 48-72 h after compared to 24 h prior to the administration of the iv study drugs.

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.

Secondary ID(s)

E-046/2001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Eli Lilly and Company

Schweizerische Herzstiftung