A Pilot Study Assessing the Safety and Efficacy of Low Dosage of Terazosin in Subjects Undergoing Carotid Artery Stenting
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 160
- 试验地点
- 2
- 主要终点
- Participants who got New DWI Lesions (MRI)
研究概览
简要总结
The purpose of this study is to assess the safety and efficacy of low dosage of Terazosin in Carotid Artery Stenting
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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;
研究组 & 干预措施
control group
Treatment: Patients in this group received standard medical therapy alone. Procedure: Carotid Artery Stenting
干预措施: Carotid artery stenting (Procedure)
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
干预措施: Terazosin (Drug)
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
干预措施: Carotid artery stenting (Procedure)
结局指标
主要结局
Participants who got New DWI Lesions (MRI)
时间窗: 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
次要结局
- 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)
- 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(From baseline to 30 days after treatment)
- Mortality(From baseline to 30 days after treatment)
研究者
Ji Xunming,MD,PhD
Professor
Xuanwu Hospital, Beijing