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

Carotid Artery Stenosis Clinical Trial

— TZ-CAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03195673
• Other study ID #: TZ-CAS
• Status: Recruiting
• Phase: Phase 2
• Start date: March 2, 2018
• Est. completion date: December 15, 2019

Study information

• Verified date: December 2018
• Source: Capital Medical University
• Contact: Xunming Ji, MD PhD
• Phone: +86-83198952
• Email: jixunming[@]vip.163.com; jiangfanghappy[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 160
• Est. completion date: December 15, 2019
• Est. primary completion date: November 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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;

Related Conditions & MeSH terms

• Carotid Artery Stenosis
• Carotid Stenosis

Intervention

Drug:
• Terazosin
TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.

Procedure:
• Carotid 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.

Locations

Country	Name	City	State
China	Beijing Anzhen Hospital	Beijing	Beijing
China	The Luhe Teaching Hospital of the Capital Medical University	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Capital Medical University	Beijing Anzhen Hospital, The Luhe Teaching Hospital of the Capital Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Laboratory Examination	Laboratory Examination before and post-treatment	Before and 24 hours after carotid artery stenting
Secondary	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
Secondary	Number of Patients with Any Side Events	Any side events caused by TZ, regular treatment or CAS	From baseline to 30 days after treatment
Secondary	Mortality	Any cause of death	From baseline to 30 days after treatment