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Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting (TZ-CAS)

Primary Purpose

Carotid Artery Stenosis

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Terazosin
Carotid artery stenting
Sponsored by
Capital Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Carotid Artery Stenosis focused on measuring Carotid artery stenting, Silent embolism, Terazosin

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;

Sites / Locations

  • Beijing Anzhen HospitalRecruiting
  • The Luhe Teaching Hospital of the Capital Medical UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

TZ group

control group

Arm Description

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

Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of New DWI Lesions (MRI)
Number of new ischemic lesions as defined by DWI MRI 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
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
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.
Laboratory Examination
Laboratory Examination before and post-treatment
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Number of Patients with Any Side Events
Any side events caused by TZ, regular treatment or CAS
Mortality
Any cause of death

Full Information

First Posted
June 20, 2017
Last Updated
December 9, 2018
Sponsor
Capital Medical University
Collaborators
The Luhe Teaching Hospital of the Capital Medical University, Beijing Anzhen Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03195673
Brief Title
Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Acronym
TZ-CAS
Official Title
A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Study Type
Interventional

2. Study Status

Record Verification Date
December 2018
Overall Recruitment Status
Unknown status
Study Start Date
March 2, 2018 (Actual)
Primary Completion Date
November 15, 2019 (Anticipated)
Study Completion Date
December 15, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
Collaborators
The Luhe Teaching Hospital of the Capital Medical University, Beijing Anzhen Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carotid Artery Stenosis
Keywords
Carotid artery stenting, Silent embolism, Terazosin

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TZ group
Arm Type
Experimental
Arm Description
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
Arm Title
control group
Arm Type
Other
Arm Description
Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
Intervention Type
Drug
Intervention Name(s)
Terazosin
Other Intervention Name(s)
TZ
Intervention Description
TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
Intervention Type
Procedure
Intervention Name(s)
Carotid artery stenting
Other Intervention Name(s)
CAS
Intervention Description
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.
Primary Outcome Measure Information:
Title
Participants who got New DWI Lesions (MRI)
Description
Patients who got new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Time Frame
Within 48 hours after carotid artery stenting
Secondary Outcome Measure Information:
Title
Number of New DWI Lesions (MRI)
Description
Number of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Time Frame
Within 48 hours after carotid artery stenting
Title
Volume of New DWI Lesions (MRI)
Description
Volume of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Time Frame
Within 48 hours after carotid artery stenting
Title
Number of patients with New DWI Lesions (MRI) diameter greater than 5mm
Description
Patients who got new ischemic lesions diameter greater than 5mm as defined by DWI MRI within 48 hours carotid artery stenting
Time Frame
Within 48 hours after carotid artery stenting
Title
Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death.
Description
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.
Time Frame
From baseline to 30 days after treatment
Title
Laboratory Examination
Description
Laboratory Examination before and post-treatment
Time Frame
Before and 24 hours after carotid artery stenting
Title
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Description
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Time Frame
0-7 days or discharge which comes early
Title
Number of Patients with Any Side Events
Description
Any side events caused by TZ, regular treatment or CAS
Time Frame
From baseline to 30 days after treatment
Title
Mortality
Description
Any cause of death
Time Frame
From baseline to 30 days after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xunming Ji, MD PhD
Phone
+86-83198952
Email
jixunming@vip.163.com; jiangfanghappy@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Fang Jiang, MD
Email
jiangfanghappy@126.com
Facility Information:
Facility Name
Beijing Anzhen Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100029
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
He Yin, MD
Facility Name
The Luhe Teaching Hospital of the Capital Medical University
City
Beijing
State/Province
Beijing
ZIP/Postal Code
101100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xiaokun Geng, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes

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

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