Carotid Artery StenosisPhase 2TZ-CASNCT03195673
Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
A Phase 2 study testing Terazosin and Carotid artery stenting in people with Carotid Artery Stenosis, run by Capital Medical University at 2 sites in China.
Trial summary
The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Carotid Artery Stenosis
- What is being tested?
- Terazosin and Carotid artery stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- 2 sitesChina
- Study dates
- 2 Mar 2018to 15 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
Trial locations and contacts
2 sites in 1 country.
Fang Jiang, MD contact
China2 sites, 2 recruiting
- Recruiting
Beijing Anzhen Hospital
Beijing, Beijing Municipality, 100029
He Yin, MD
- Recruiting
The Luhe Teaching Hospital of the Capital Medical University
Beijing, Beijing Municipality, 101100
Xiaokun Geng, MD
About this study
Official title: 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
- Conditions
- Carotid Artery Stenosis
- Being tested
- Terazosin, Carotid artery stenting
- Keywords
- Carotid artery stenting, Silent embolism, Terazosin
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TerazosinDrug
Also called TZ
TZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later.
Carotid artery stentingProcedure or surgery
Also called CAS
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Terazosin; Procedure: Carotid artery stenting |
| control group | Other | Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting Receives: Procedure: Carotid artery stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Within 48 hours after carotid artery stenting
Secondary outcomes (8)
Number of New DWI Lesions (MRI)
Number of new ischemic lesions as defined by DWI MRI within 48 hours after carotid artery stenting
Measured: 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
Measured: 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
Measured: 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.
Measured: From baseline to 30 days after treatment
Laboratory Examination
Laboratory Examination before and post-treatment
Measured: 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
Measured: 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
Measured: From baseline to 30 days after treatment
Mortality
Any cause of death
Measured: From baseline to 30 days after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2017
- Study start2 Mar 2018
- Primary completion15 Nov 2019 (estimated)
- Study completion15 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University, Beijing Anzhen Hospital
- Responsible party
- Principal investigator, Ji Xunming,MD,PhD, Xuanwu Hospital, Beijing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03195673
- Sponsor's protocol ID
- TZ-CAS
- Acronym
- TZ-CAS
- Status last verified
- Dec 2018
- First submitted
- 20 Jun 2017
- Last updated
- 11 Dec 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
- ClinicalTrials.gov ID
- NCT03195673
- Acronym / sponsor ID
- TZ-CAS / TZ-CAS
- Conditions
- Carotid Artery Stenosis
- Keywords
- Carotid artery stenting, Silent embolism, Terazosin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- The Luhe Teaching Hospital of the Capital Medical University, Beijing Anzhen Hospital
- Study start
- 2 Mar 2018 (actual)
- Primary completion
- 15 Nov 2019 (estimated)
- Study completion
- 15 Dec 2019 (estimated)
- First posted
- 22 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TZ group | Experimental | Drug: Terazosin, Procedure: Carotid artery stentingTreatment: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 |
| control group | Other | Procedure: Carotid artery stentingTreatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TerazosinAlso: TZTZ 0.5mg once a day for 3-7 days before carotid artery stenting to 30 days later. | Drug | TZ group |
| Carotid artery stentingAlso: CASCarotid 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. | Procedure or surgery | TZ group, control group |
Primary outcome
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
8 secondary outcomes
Number of New DWI Lesions (MRI)
Time frame: Within 48 hours after carotid artery stenting
Volume of New DWI Lesions (MRI)
Time frame: 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
Number of Patients with Cerebrovascular Events, Cardiovascular Events or Death.
Time frame: From baseline to 30 days after treatment
Laboratory Examination
Time frame: Before and 24 hours after carotid artery stenting
Number of Patients underwent hypertensive treatment due to post-procedure hypotention
Time frame: 0-7 days or discharge which comes early
Number of Patients with Any Side Events
Time frame: From baseline to 30 days after treatment
Mortality
Time frame: From baseline to 30 days after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2018.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fang Jiang, MD contact
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Terazosin and Carotid artery stenting in people with Carotid Artery Stenosis, run by Capital Medical University at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xunming Ji, MD PhD (+86-83198952, jixunming@vip.163.com; jiangfanghappy@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participants who got New DWI Lesions (MRI) (time frame: Within 48 hours after carotid artery stenting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2018.