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

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

Condition or disease Intervention/treatment Phase
Carotid Artery Stenosis Drug: Terazosin Procedure: Carotid artery stenting Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 160 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
Actual Study Start Date : March 2, 2018
Estimated Primary Completion Date : November 15, 2019
Estimated Study Completion Date : December 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 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

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 Name: CAS




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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.

  5. Laboratory Examination [ Time Frame: Before and 24 hours after carotid artery stenting ]
    Laboratory Examination before and post-treatment

  6. 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

  7. 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

  8. Mortality [ Time Frame: From baseline to 30 days after treatment ]
    Any cause of death



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03195673


Contacts
Layout table for location contacts
Contact: Xunming Ji, MD PhD +86-83198952 jixunming@vip.163.com; jiangfanghappy@126.com
Contact: Fang Jiang, MD jiangfanghappy@126.com

Locations
Layout table for location information
China, Beijing
Beijing Anzhen Hospital Recruiting
Beijing, Beijing, China, 100029
Contact: He Yin, MD         
The Luhe Teaching Hospital of the Capital Medical University Recruiting
Beijing, Beijing, China, 101100
Contact: Xiaokun Geng, MD         
Sponsors and Collaborators
Capital Medical University
The Luhe Teaching Hospital of the Capital Medical University
Beijing Anzhen Hospital

Layout table for additonal information
Responsible Party: Ji Xunming,MD,PhD, Professor, Xuanwu Hospital, Beijing
ClinicalTrials.gov Identifier: NCT03195673     History of Changes
Other Study ID Numbers: TZ-CAS
First Posted: June 22, 2017    Key Record Dates
Last Update Posted: December 11, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing:
Carotid artery stenting
Silent embolism
Terazosin

Additional relevant MeSH terms:
Layout table for MeSH terms
Carotid Stenosis
Carotid Artery Diseases
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Terazosin
Prazosin
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Urological Agents
Antihypertensive Agents