Clinical trial NCT03195673: Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Official title: A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Carotid Artery Stenosis
Keywords: Carotid artery stenting
Silent embolism
Terazosin
Lead sponsor: Capital Medical University
Sponsor class: OTHER
Collaborators: name: The Luhe Teaching Hospital of the Capital Medical University
name: Beijing Anzhen Hospital
First posted: 2017-06-22
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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;

Primary outcomes:
measure: Participants who got New DWI Lesions (MRI)
timeFrame: Within 48 hours after carotid artery stenting
Secondary outcomes:
measure: Number of New DWI Lesions (MRI)
timeFrame: Within 48 hours after carotid artery stenting
measure: Volume of New DWI Lesions (MRI)
timeFrame: Within 48 hours after carotid artery stenting
measure: Number of patients with New DWI Lesions (MRI) diameter greater than 5mm
timeFrame: Within 48 hours after carotid artery stenting
measure: Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death.
timeFrame: From baseline to 30 days after treatment
measure: Laboratory Examination
timeFrame: Before and 24 hours after carotid artery stenting
measure: Number of Patients underwent hypertensive treatment due to post-procedure hypotention
timeFrame: 0-7 days or discharge which comes early
measure: Number of Patients with Any Side Events
timeFrame: From baseline to 30 days after treatment
measure: Mortality
timeFrame: From baseline to 30 days after treatment
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: The Luhe Teaching Hospital of the Capital Medical University
state: Beijing
Study officials:
References: