Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting

Study Overview
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Brief Summary
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The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting

Official Title
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A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting

Conditions
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Carotid Artery Stenosis

Intervention / Treatment
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* Drug: Terazosin
* Procedure: Carotid artery stenting


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Symptomatic or asymptomatic carotid artery stenosis. In symptomatic patients the degree of stenosis should more than 50% (Based on NASCET Criteria), in asymptomatic patients the degree of stenosis should more than 70% (Based on NASCET Criteria); Tolerance to any of the study medications, including TZ, clopidogrel, aspirin and statins; Hypertensive patients with or without oral antihypertensive drugs Can cooperate with and complete brain MRI examination; Stable vital signs, cardiopulmonary, liver and kidney function was no obvious abnormalities; Has a negative pregnancy test within 7 days before randomization and no childbearing potential; Stable vital sign, normal renal and hepatic functions; Informed consent. Exclusion Criteria: Evolving stroke; Hemorrhagic tendency； Severe dementia or Prior major ipsilateral stroke, if likely to confound study endpoints; Chronic atrial fibrillation or any other Cardiogenic emboli source disease; Myocardial infarction within previous 30 days; Spontaneous Intracerebral Hemorrhage within the past 180 days, Hemorrhagic conversion of an ischemic stroke within the past 60 days or recent (<7 days) large area cerebral infarction has a hemorrhagic conversion tendence; Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe; High risk candidates of CAS defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST); Thiazides taken within 14 days before randomization; Participating in any other clinical trial that has not completed the required protocol follow-up period;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TZ group<br>Treatment:Patients in this group received standard medical therapy and Terazosin (TZ) treatment. Drug: TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later. Procedure: Carotid Artery Stenting | Drug: Terazosin<br>* TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.<br>* Other names: TZ;Procedure: Carotid artery stenting<br>* Carotid artery stenting is an alternative treatment of carotid artery stenosis, which would be performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.<br>* Other names: CAS;|
| Other: control group<br>Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting | Procedure: Carotid artery stenting<br>* Carotid artery stenting is an alternative treatment of carotid artery stenosis, which would be performed by experienced neuroradiologist according to the latest guideline from American Heart Association and American Stroke Association.<br>* Other names: CAS;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participants who got New DWI Lesions (MRI) | Patients who got new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting | Within 48 hours after carotid artery stenting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of New DWI Lesions (MRI) | Number of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting | Within 48 hours after carotid artery stenting | 
| Volume of New DWI Lesions (MRI) | Volume of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting | Within 48 hours after carotid artery stenting | 
| Number of patients with New DWI Lesions (MRI) diameter greater than 5mm | Patients who got new ischemic lesions diameter greater than 5mm as defined by DWI MRI within 48 hours carotid artery stenting | Within 48 hours after carotid artery stenting | 
| Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death. | Cerebrovascular events included ischemic stroke, transient ischemic attack (TIA), cerebral hemorrhage and hyperperfusion syndrome. Cardiovascular events included angina and myocardial infarction. Death included any reason caused death. | From baseline to 30 days after treatment | 
| Laboratory Examination | Laboratory Examination before and post-treatment | Before and 24 hours after carotid artery stenting | 
| Number of Patients underwent hypertensive treatment due to post-procedure hypotention | Number of Patients underwent hypertensive treatment due to post-procedure hypotention | 0-7 days or discharge which comes early | 
| Number of Patients with Any Side Events | Any side events caused by TZ, regular treatment or CAS | From baseline to 30 days after treatment | 
| Mortality | Any cause of death | From baseline to 30 days after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Carotid artery stenting, Silent embolism, Terazosin