Stroke Prevention With Abciximab in Carotid Endarterectomy
2 other identifiers
interventional
N/A
1 country
1
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 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.
Trial Health
Trial Health Score
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 15, 2005
CompletedDecember 18, 2015
December 1, 2015
September 12, 2005
December 17, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
the safety of Abciximab in patients undergoing carotid endarterectomy. This dose ranging study will seek to define the optimal dose regimen for safe use of Abciximab in patients with asymptomatic >75% carotid artery stenosis.
Secondary Outcomes (1)
Determine incidence of microemboli recorded on transcranial Doppler imaging during carotid endarterectomy with use of Abciximab.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Rochesterlead
- Eli Lilly and Companycollaborator
Study Sites (1)
University of Rochester Medical Center- Strong Memorial Hospital
Rochester, New York, 14642, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
William S Burgin, MD
University of Rochester
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 15, 2005
Last Updated
December 18, 2015
Record last verified: 2015-12