Carotid Artery Stenosis
Conditions
Keywords
Carotid artery stenting, Silent embolism, Terazosin
Brief summary
The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting
Interventions
DRUGTerazosin
TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
PROCEDURECarotid artery stenting
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.
Sponsors
The Luhe Teaching Hospital of the Capital Medical University
Beijing Anzhen Hospital
Capital Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 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); 2. Tolerance to any of the study medications, including TZ, clopidogrel, aspirin and statins; 3. Hypertensive patients with or without oral antihypertensive drugs 4. Can cooperate with and complete brain MRI examination; 5. Stable vital signs, cardiopulmonary, liver and kidney function was no obvious abnormalities; 6. Has a negative pregnancy test within 7 days before randomization and no childbearing potential; 7. Stable vital sign, normal renal and hepatic functions; 8. Informed consent.
Exclusion criteria
1. Evolving stroke; 2. Hemorrhagic tendency； 3. Severe dementia or Prior major ipsilateral stroke, if likely to confound study endpoints; 4. Chronic atrial fibrillation or any other Cardiogenic emboli source disease; 5. Myocardial infarction within previous 30 days; 6. 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; 7. Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe; 8. High risk candidates of CAS defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST); 9. Thiazides taken within 14 days before randomization; 10. Participating in any other clinical trial that has not completed the required protocol follow-up period;
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Participants who got New DWI Lesions (MRI) | Within 48 hours after carotid artery stenting | Patients who got new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Volume of New DWI Lesions (MRI) | Within 48 hours after carotid artery stenting | Volume of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting |
| Number of patients with New DWI Lesions (MRI) diameter greater than 5mm | Within 48 hours after carotid artery stenting | Patients who got new ischemic lesions diameter greater than 5mm as defined by DWI MRI within 48 hours carotid artery stenting |
| Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death. | From baseline to 30 days after treatment | 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. |
| Number of New DWI Lesions (MRI) | Within 48 hours after carotid artery stenting | Number of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting |
| Number of Patients underwent hypertensive treatment due to post-procedure hypotention | 0-7 days or discharge which comes early | Number of Patients underwent hypertensive treatment due to post-procedure hypotention |
| Number of Patients with Any Side Events | From baseline to 30 days after treatment | Any side events caused by TZ, regular treatment or CAS |
| Mortality | From baseline to 30 days after treatment | Any cause of death |
| Laboratory Examination | Before and 24 hours after carotid artery stenting | Laboratory Examination before and post-treatment |
Countries
China
Contacts
Primary ContactXunming Ji, MD PhD
Backup ContactFang Jiang, MD
Outcome results
None listed