NCT03195673

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
160

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Mar 2018

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 20, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 22, 2017

Completed
8 months until next milestone

Study Start

First participant enrolled

March 2, 2018

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 15, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2019

Completed
Last Updated

December 11, 2018

Status Verified

December 1, 2018

Enrollment Period

1.7 years

First QC Date

June 20, 2017

Last Update Submit

December 9, 2018

Conditions

Carotid Artery Stenosis

Keywords

Carotid artery stentingSilent embolismTerazosin

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Number of New DWI Lesions (MRI)

    Within 48 hours after carotid artery stenting

  • Volume of New DWI Lesions (MRI)

    Within 48 hours after carotid artery stenting

  • Number of patients with New DWI Lesions (MRI) diameter greater than 5mm

    Within 48 hours after carotid artery stenting

  • Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death.

    From baseline to 30 days after treatment

  • Laboratory Examination

    Before and 24 hours after carotid artery stenting

  • +3 more secondary outcomes

Study Arms (2)

TZ group

EXPERIMENTAL

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: TerazosinProcedure: Carotid artery stenting

control group

OTHER

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

Procedure: Carotid artery stenting

Interventions

TerazosinDRUG

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

Also known as: TZ
TZ group
Carotid artery stentingPROCEDURE

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.

Also known as: CAS
TZ groupcontrol group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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);
  • Tolerance to any of the study medications, including TZ, clopidogrel, aspirin and statins;
  • Hypertensive patients with or without oral antihypertensive drugs
  • Can cooperate with and complete brain MRI examination;
  • Stable vital signs, cardiopulmonary, liver and kidney function was no obvious abnormalities;
  • Has a negative pregnancy test within 7 days before randomization and no childbearing potential;
  • Stable vital sign, normal renal and hepatic functions;
  • Informed consent.

You may not qualify if:

  • Evolving stroke;
  • Hemorrhagic tendency；
  • Severe dementia or Prior major ipsilateral stroke, if likely to confound study endpoints;
  • Chronic atrial fibrillation or any other Cardiogenic emboli source disease;
  • Myocardial infarction within previous 30 days;
  • 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;
  • Any conditions that hampers proper angiographic assessment or makes percutaneous arterial access unsafe;
  • High risk candidates of CAS defined as the Carotid Revascularization Endarterectomy vs. Stenting Trial (CREST);
  • Thiazides taken within 14 days before randomization;
  • Participating in any other clinical trial that has not completed the required protocol follow-up period;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Beijing Anzhen Hospital

Beijing, Beijing Municipality, 100029, China

RECRUITING

The Luhe Teaching Hospital of the Capital Medical University

Beijing, Beijing Municipality, 101100, China

RECRUITING

MeSH Terms

Conditions

Carotid Stenosis

Interventions

Terazosin

Condition Hierarchy (Ancestors)

Carotid Artery DiseasesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesArterial Occlusive DiseasesVascular DiseasesCardiovascular Diseases

Central Study Contacts

Xunming Ji, MD PhD

CONTACT

+86-83198952jixunming@vip.163.com; jiangfanghappy@126.com

Fang Jiang, MD

CONTACT

jiangfanghappy@126.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 20, 2017

First Posted

June 22, 2017

Study Start

March 2, 2018

Primary Completion

November 15, 2019

Study Completion

December 15, 2019

Last Updated

December 11, 2018

Record last verified: 2018-12

Data Sharing

IPD Sharing
Will share

Locations

CN(2)