Stroke Prevention With Abciximab in Carotid Endarterectomy

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

In the first portion of the study, the goal will be to determine the safety of the drug Abciximab for use during and in the period after open carotid artery surgery. In addition, using specialized ultrasound equipment (a probe that is placed on the outside of your skin of your head), we will aim to measure the number of particles released around the time of surgery while being treated with Abciximab. The second phase of the study will be determine if Abciximab can safely reduce the number of particles released into the bloodstream around the time of surgery in order to reduce the risk of stroke.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Rochester
• Collaborator: Eli Lilly and Company
• Treatments: Abciximab; Antibodies, Monoclonal; Immunoglobulin Fab Fragments

Criteria

Inclusion Criteria:

Subjects will be eligible if the following criteria are met:

• Ability to provide written informed consent and comply with study assessments for the full duration of the study.

• Age >18 years

• Diagnosis of >75% asymptomatic carotid artery stenosis by ultrasound or angiographic evaluation

• No contraindication to Abciximab or anticoagulation

• Ability to insonate an adequate window for Transcranial Doppler Imaging pre-operatively

• In women of childbearing capacity a negative pregnancy test

• Signed authorization of release of protected health care information

Exclusion Criteria:

• Inability to insonate an ipsilateral window; bilateral monitoring will be performed when possible.

• CT or MRI positive CVA within past 12 weeks

• Active internal bleeding

• Recent within six weeks gastrointestinal or genitourinary bleeding of clinical significance

• Bleeding diathesis

• Administration of oral anti-coagulants within seven days unless prothrombin time is less than or equal to 1.2 times control

• History of CVA within two years or CVA with a significant residual neurological deficit

• Thrombocytopenia (<100,000 cells/uL)

• Recent (within six weeks) major surgery or trauma Intracranial neoplasm, AVM, or aneurysm

• Severe uncontrolled hypertension

• Presumed or documented history of vasculitis

• Use of intravenous dextran before PCI or intent to use during an intervention

• Known hypersensitivity to any component of ReoPro

• Known hypersensitivity to murine proteins