Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03195673
Recruitment Status : Recruiting
First Posted : June 22, 2017
Last Update Posted : December 11, 2018
Sponsor:
Collaborators:
The Luhe Teaching Hospital of the Capital Medical University
Beijing Anzhen Hospital
Information provided by (Responsible Party):
Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing

Tracking Information
First Submitted Date  ICMJE June 20, 2017
First Posted Date  ICMJE June 22, 2017
Last Update Posted Date December 11, 2018
Actual Study Start Date  ICMJE March 2, 2018
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03195673 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: December 9, 2018)
  • 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
  • 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
  • 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
  • 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.
  • Laboratory Examination [ Time Frame: 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 [ Time Frame: 0-7 days or discharge which comes early ]
    Number of Patients underwent hypertensive treatment due to post-procedure hypotention
  • 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
  • Mortality [ Time Frame: From baseline to 30 days after treatment ]
    Any cause of death
Original Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2017)
  • 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
  • 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
  • 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
  • Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death. [ Time Frame: From baseline to 1, 3, 6 and 12 months 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 [ Time Frame: Before, 2 and 24 hours after carotid artery stenting ]
    Laboratory Examination before and post-treatment
  • Change of MMSE (Mini-mental State ExaminatIon) [ Time Frame: Before carotid artery stenting and 3, 6 and 12 months later ]
    Change of MMSE between treatment before and 3, 6 and 12 months later
  • Change of MoCA (Montreal cognitive assessment) [ Time Frame: Before carotid artery stenting and 3, 6 and 12 months later ]
    Change of MoCA between treatment before and 3, 6 and 12 months later
  • 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
  • Number of Patients with Any Side Events [ Time Frame: From baseline to 1, 3, 6 and 12 months after treatment ]
    Any side events caused by TZ, regular treatment or CAS
  • Mortality [ Time Frame: From baseline to 1, 3, 6 and 12 months after treatment ]
    Any cause of death
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Official Title  ICMJE A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Carotid Artery Stenosis
Intervention  ICMJE
  • Drug: Terazosin
    TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
    Other Name: 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 Name: CAS
Study Arms  ICMJE
  • 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

    Interventions:
    • Drug: Terazosin
    • Procedure: Carotid artery stenting
  • control group
    Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
    Intervention: Procedure: Carotid artery stenting
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 9, 2018)
160
Original Estimated Enrollment  ICMJE
 (submitted: June 20, 2017)
60
Estimated Study Completion Date  ICMJE December 15, 2019
Estimated Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xunming Ji, MD PhD +86-83198952 jixunming@vip.163.com; jiangfanghappy@126.com
Contact: Fang Jiang, MD jiangfanghappy@126.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03195673
Other Study ID Numbers  ICMJE TZ-CAS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Responsible Party Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
Study Sponsor  ICMJE Capital Medical University
Collaborators  ICMJE
  • The Luhe Teaching Hospital of the Capital Medical University
  • Beijing Anzhen Hospital
Investigators  ICMJE Not Provided
PRS Account Capital Medical University
Verification Date December 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP