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

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: Unknown
• Conditions: Carotid Artery Stenosis
• Intervention / Treatment: Drug: Terazosin; Procedure: Carotid artery stenting

• Study Type: Interventional
• Enrollment (Anticipated): 160
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Xunming Ji, MD PhD; Phone Number: +86-83198952; Email: jixunming@vip.163.com; jiangfanghappy@126.com
• Study Contact Backup: Name: Fang Jiang, MD; Email: jiangfanghappy@126.com

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / 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 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

Outcome Measure	Measure Description	Time Frame
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	Within 48 hours after carotid artery stenting

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of New DWI Lesions (MRI)	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)	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	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.	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	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	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	Any side events caused by TZ, regular treatment or CAS	From baseline to 30 days after treatment
Mortality	Any cause of death	From baseline to 30 days after treatment

Collaborators and Investigators

• Sponsor: Capital Medical University
• Collaborators: Beijing Anzhen Hospital; The Luhe Teaching Hospital of the Capital Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 2, 2018
• Primary Completion (ANTICIPATED): November 15, 2019
• Study Completion (ANTICIPATED): December 15, 2019

Study Registration Dates

• First Submitted: June 20, 2017
• First Submitted That Met QC Criteria: June 20, 2017
• First Posted (ACTUAL): June 22, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 11, 2018
• Last Update Submitted That Met QC Criteria: December 9, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Keywords: Carotid artery stenting; Terazosin; Silent embolism
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Arterial Occlusive Diseases; Carotid Artery Diseases; Carotid Stenosis; Physiological Effects of Drugs; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Urological Agents; Adrenergic alpha-1 Receptor Antagonists; Adrenergic alpha-Antagonists; Terazosin
• Other Study ID 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