Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting

NCT ID: NCT03195673

Last Updated: 2018-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-02

Study Completion Date

2019-12-15

Brief Summary

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

Detailed Description

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Conditions

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Carotid Artery Stenosis

Keywords

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Carotid artery stenting Silent embolism Terazosin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Terazosin

Intervention Type DRUG

TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.

Carotid artery stenting

Intervention Type PROCEDURE

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.

control group

Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting

Group Type OTHER

Carotid artery stenting

Intervention Type PROCEDURE

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.

Interventions

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Terazosin

TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Other Intervention Names

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TZ CAS

Eligibility Criteria

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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;
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Luhe Teaching Hospital of the Capital Medical University

OTHER

Sponsor Role collaborator

Beijing Anzhen Hospital

OTHER

Sponsor Role collaborator

Capital Medical University

OTHER

Sponsor Role lead

Responsible Party

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Ji Xunming,MD,PhD

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Beijing Anzhen Hospital

Beijing, Beijing Municipality, China

Site Status RECRUITING

The Luhe Teaching Hospital of the Capital Medical University

Beijing, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xunming Ji, MD PhD

Role: CONTACT

Phone: +86-83198952

Email: [email protected]; [email protected]

Fang Jiang, MD

Role: CONTACT

Email: [email protected]

Facility Contacts

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He Yin, MD

Role: primary

Xiaokun Geng, MD

Role: primary

Other Identifiers

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TZ-CAS

Identifier Type: -

Identifier Source: org_study_id