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

December 9, 2018 updated by: Ji Xunming,MD,PhD, Capital Medical University

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
160

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100029
        • Recruiting
        • Beijing Anzhen Hospital
        • Contact:
          • He Yin, MD
      • Beijing, Beijing, China, 101100
        • Recruiting
        • The Luhe Teaching Hospital of the Capital Medical University
        • Contact:
          • Xiaokun Geng, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: TZ group

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
Drug: Terazosin
TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
Other Names:
  • TZ
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.
Other Names:
  • CAS
OTHER: control group
Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
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.
Other Names:
  • CAS

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Participants who got New DWI Lesions (MRI)
Time Frame: 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
Within 48 hours after carotid artery stenting

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of New DWI Lesions (MRI)
Time Frame: Within 48 hours after carotid artery stenting
Number of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Within 48 hours after carotid artery stenting
Volume of New DWI Lesions (MRI)
Time Frame: Within 48 hours after carotid artery stenting
Volume of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Within 48 hours after carotid artery stenting
Number of patients with New DWI Lesions (MRI) diameter greater than 5mm
Time Frame: 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
Within 48 hours after carotid artery stenting
Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death.
Time Frame: 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.
From baseline to 30 days after treatment
Laboratory Examination
Time Frame: Before and 24 hours after carotid artery stenting
Laboratory Examination before and post-treatment
Before and 24 hours after carotid artery stenting
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Time Frame: 0-7 days or discharge which comes early
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
0-7 days or discharge which comes early
Number of Patients with Any Side Events
Time Frame: From baseline to 30 days after treatment
Any side events caused by TZ, regular treatment or CAS
From baseline to 30 days after treatment
Mortality
Time Frame: From baseline to 30 days after treatment
Any cause of death
From baseline to 30 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Capital Medical University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Beijing Anzhen Hospital
The Luhe Teaching Hospital of the Capital Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 2, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 15, 2019

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 15, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 20, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 20, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 22, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 11, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TZ-CAS

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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