Stroke Prevention With Abciximab in Carotid Endarterectomy

Status:

WITHDRAWN

Stroke Prevention With Abciximab in Carotid Endarterectomy

Lead Sponsor:

University of Rochester

Collaborating Sponsors:

Eli Lilly and Company

Conditions:

Carotid Stenosis

Eligibility:

All Genders

18+ years

Phase:

PHASE1

PHASE2

Brief 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 ult...

Detailed Description

Carotid endarterectomy is the most frequently performed vascular procedure in the United States. In the last decade, there has been a large increase in case volume following confirmation of the effica...

Eligibility Criteria

Inclusion

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

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

Key Trial Info

Start Date :

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

Patients enrolled

Trial Details

Trial ID

NCT00178451

Last Update

December 18 2015

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