Effect of Cilostazol on In-stent Restenosis After Carotid Artery Stenting; Multi-center, Prospective, Randomized, Open-label Blind-endpoint Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 707
- 试验地点
- 1
- 主要终点
- Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence
研究概览
简要总结
CAS-CARE study was conducted to evaluate the inhibitory effect of cilostazol, compared to that of other antiplatelet drugs, on in-stent restenosis following carotid artery stenting (CAS) in patients scheduled to undergo CAS. Study design is Multicenter Prospective Ranodomized Controlled Study, rondomized by cilostazol/non-cilostazol group prior to CAS. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography.
详细描述
Restenosis after carotid artery stenting (CAS) is a critical issue. Cilostazol can reduce restenosis after interventions in coronary or femoropopliteal arteries. The investigators confirmed and published periprocedural cilostazol administration reduced incidences of in-stent restenosis (ISR) or target vessel revascularization (TVR) after CAS, retrospectively.
CAS-CARE study is Multicenter Prospective Ranodomized Controlled Study. Patients, scheduled for CAS within 30 days, 50% or more symptomatic carotid stenosis or 80% or more asymptomatic carotid stenosis, will enroll and randomize by cilostazol/non-cilostazol group. 900 patients will be enrolled for 2 years and followed 2 years with in-stent restenosis after CAS, evaluated by carotid ultrasound and angiography. And, evaluate cardiovascular events, including stroke, myocardial infarction, and hemorrhagic events in periprocedural period and followed period. In this study, ISR is diagnosed by ultrasound and DSA/CTA. Equivalence of CTA to ultrasound will be studied.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •50% or more symptomatic carotid artery stenosis or 80% or more asymptomatic carotid artery stenosis
- •scheduled for carotid artery stenting within 30 days
- •45 or more years-old and less than 80 years old
- •antiplatelet agents can be administratered orally
- •follow-up is anticipated possible for 2 years after CAS
- •self-supporoted in daily activities (modified Rankin Scale 2 or less)
- •patients who have given informed consent to participation in the study
排除标准
- •received endovascular interevention
- •scheduled for bilateral carotid intervention
- •aortitis or cvasculitis
- •congessive heart failure
- •ischemic stroke within 48 hours
- •hemorrhagic stroke within 90 days
- •renal failure
研究组 & 干预措施
Cilostazol group
Continuous administration of cilostazol (unrestricted use of other antiplatelet agents and concomitant drugs)
干预措施: Cilostazol or Non-Cilostazol (Drug)
Non-Cilostazol group
Antiplatelet agent other than cilostazol (unrestricted use of concomitant drugs)
干预措施: Cilostazol or Non-Cilostazol (Drug)
结局指标
主要结局
Presence or absence of in-stent restenosis within 2 years after CAS and time to occurrence
时间窗: 2 years
Difinition of endpoint is 50% or more in-stent restenosis detected by carotid ultrasound or angiopraphy. In cases restenosis does not occur, the final observation point will be used as the final evaluation point.
次要结局
- stroke within 2 years(2 years)
- In-stent restenosis, new out-stent stenosis, or retreatment within 2 years(2 years)
- In-stent restenosis, new out-stent stenosis, or retreatment of stented artery, cardiovascular event, or death from any cause within 30 days(30 days)
- Cardiovascular event, death, hemorrhagic event, in-stent restenosis, new out-stent stenosis, or retreatment of stented artery within 2 yrs(2 years)
- hemorrhagic event within 2 years(2 years)
- Severe in-stent restenosis within 2 yrs(2 yeras)
- Change from baseline in max-IMT in both common carotid arteries(2 years)
研究者
Nobuyuki Sakai
Director, Neurosurgery
Kobe City General Hospital