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

Phase 2

• Conditions: Carotid Artery Stenosis
• Interventions: Drug: Terazosin; Procedure: Carotid artery stenting

• Registration Number: NCT03195673
• Lead Sponsor: Capital Medical University

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-06-20
• Study First Submitted QC: 2017-06-20
• Study First Posted: 2017-06-22
• Study Start: 2018-03-02
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-09
• Last Update Posted: 2018-12-11
• Primary Completion: 2019-11-15
• Study Completion: 2019-12-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 160

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TZ group	Carotid artery stenting	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
control group	Carotid artery stenting	Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
TZ group	Terazosin	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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Laboratory Examination	Before and 24 hours after carotid artery stenting	Laboratory Examination before and post-treatment
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 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
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 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

Trial Locations

Locations (2)

The Luhe Teaching Hospital of the Capital Medical University; 🇨🇳 Beijing, Beijing, China

Beijing Anzhen Hospital; 🇨🇳 Beijing, Beijing, China