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

• ClinicalTrials.gov Identifier: NCT03195673
• Recruitment Status: Recruiting
• First Posted: June 22, 2017
• Last Update Posted: December 11, 2018
• Sponsor: Capital Medical University
• 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: June 20, 2017
• First Posted Date: June 22, 2017
• Last Update Posted Date: December 11, 2018
• Actual Study Start Date: March 2, 2018
• Estimated Primary Completion Date: November 15, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Change History: Complete list of historical versions of study NCT03195673 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (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 (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: Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
• Official Title: 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: Carotid Artery Stenosis

Intervention

• 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

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 9, 2018): 160
• Original Estimated Enrollment (submitted: June 20, 2017): 60
• Estimated Study Completion Date: December 15, 2019
• Estimated Primary Completion Date: November 15, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years to 80 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Xunming Ji, MD PhD; +86-83198952; jixunming@vip.163.com; jiangfanghappy@126.com

Contact: Fang Jiang, MD; jiangfanghappy@126.com

• Listed Location Countries: China

Administrative Information

• NCT Number: NCT03195673
• Other Study ID Numbers: 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

• Plan to Share IPD: Yes

• Responsible Party: Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
• Study Sponsor: Capital Medical University

Collaborators

• The Luhe Teaching Hospital of the Capital Medical University
• Beijing Anzhen Hospital

• Investigators: Not Provided
• PRS Account: Capital Medical University
• Verification Date: December 2018