- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00178451
Stroke Prevention With Abciximab in Carotid Endarterectomy
Study Overview
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 efficacy of endarterectomy for carotid artery atherosclerotic disease by the NASCET and ACAS trials. Estimates for 1994 suggested that over 130,000 patients underwent carotid endarterectomy in the United States.
Despite the efficacy of endarterectomy over medical management for extra cranial cerebral vascular disease, the risk of having an ipsilateral perioperative stroke after carotid endarterectomy remains at 2-7%. There are two main types of operation-related stroke. The intra-operative stroke is apparent upon recovery from anesthesia and is directly attributable to intra-operative ischemia or embolization. The post-operative stroke occurs sometime after an uneventful recovery from surgery and is due to vessel occlusion or embolization off the thrombogenic endarterectomy surface. Evidence suggests that platelets adhere to the exposed collagen of the endarterectomy surface within minutes of restoring flow. The maximal rate of adherence appears to be one hour after clamp release. Postoperative strokes are preceded by micro-particulate embolization, which can be detected by transcranial Doppler ultrasound. There is good correlation between TCD detection of 25 or more emboli in the middle cerebral artery distribution during any ten-minute period after surgery and an increased occurrence of transient ischemic attack and or stroke. Another study found an embolic rate greater than 50 per hour predicted stroke in 50% of patients.
Further study by TCD of the prevalence of post-operative micro particulate thromboembolic events after carotid endarterectomy found five percent of patients have sustained postoperative embolization. The embolic rate is maximal in the first two hours postoperatively and if no evidence is found for embolization by the third post-operative hour then it is unlikely to occur thereafter. Infusion of Dextran 40 has been shown to decrease the rate of embolization of micro particulate debris.
Recent success in decreasing thrombotic events in both percutaneous coronary interventions and acute myocardial infarction with platelet glycoprotein IIB/IIIA antagonists has stimulated interest in furthering the applications of these drugs. A recent randomized clinical trial using Abciximab in acute ischemic stroke documented safety when administered up to twenty-four hours after stroke onset, with a trend toward improvement in functional outcomes. Abciximab has also been used in conjunction with heparin and aspirin in carotid artery percutaneous angioplasty and stenting and is thought to potentially reduce recurrent stenoses. Unfortunately, the use of platelet IIb/IIIa inhibitors with open surgical procedures not been studied due to concerns of bleeding.
Study Aims:
Use of a platelet glycoprotein IIb/IIIa antagonist holds great potential for diminishing or eliminating the micro particulate embolization seen with TCD and thus helping lower the combined operative morbidity and mortality to less than the five percent rate that is commonly accepted. Our primary aim is to document the safety and ideal dosing of Abciximab for use in open vascular surgery, namely Carotid Endarterectomy. Our secondary aim is to evaluate the incidence of perioperative embolic events after carotid endarterectomy as monitored by transcranial Doppler with the perioperative administration of Abciximab.
Study Type
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
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New York
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Rochester, New York, United States, 14642
- University of Rochester Medical Center- Strong Memorial Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Allocation: RANDOMIZED
- Interventional Model: SINGLE_GROUP
- Masking: DOUBLE
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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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.
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Secondary Outcome Measures
Outcome Measure |
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Determine incidence of microemboli recorded on transcranial Doppler imaging during carotid endarterectomy with use of Abciximab.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: William S Burgin, MD, University of Rochester
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RSRB 10187
- H4S-MC-1018
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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