Double Blind Placebo Controlled Multicenter Trial for Prevention of IMT Progression in the Ischemic Stroke Patients With High Risk of Cerebral Hemorrhage With Cilostazol and Probucol
试验速览
- 阶段
- 4 期
- 入组人数
- 800
- 主要终点
- mean carotid IMT progression
研究概览
简要总结
Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.
The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of ischemic stroke within 120 days
- •Adult aged 20 years or older
- •High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
- •Informed consent
排除标准
- •Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks
- •Bleeding tendency
- •Pregnant or breast-feeding woman
- •Hemorrhagic stroke within 6 months
- •Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
- •Severe cardiovascular disease such as cardiomyopathy or congestive heart failure
- •Life expectancy less than one year
- •Contraindication to long term aspirin use
- •Enrolled in other clinical trial within 30 days
研究组 & 干预措施
Cilostazol
cilostazol plus placebo of aspirin
干预措施: Placebo of aspirin (Drug)
Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
干预措施: cilostazol (Drug)
Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
干预措施: Probucol (Drug)
Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
干预措施: Placebo of aspirin (Drug)
Cilostazol+ Probucol
100mg cilostazol bid plus probucol plus placebo of aspirin
干预措施: Intima-medial thickness (Device)
Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
干预措施: Probucol (Drug)
Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
干预措施: Aspirin (Drug)
Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
干预措施: placebo of cilostazol (Drug)
Aspirin + Probucol
aspirin plus placebo cilostazol plus probucol
干预措施: Intima-medial thickness (Device)
Cilostazol
cilostazol plus placebo of aspirin
干预措施: cilostazol (Drug)
Cilostazol
cilostazol plus placebo of aspirin
干预措施: Intima-medial thickness (Device)
Aspirin
aspirin plus placebo of cilostazol
干预措施: Aspirin (Drug)
Aspirin
aspirin plus placebo of cilostazol
干预措施: placebo of cilostazol (Drug)
Aspirin
aspirin plus placebo of cilostazol
干预措施: Intima-medial thickness (Device)
结局指标
主要结局
mean carotid IMT progression
时间窗: one year
Annualized rate of change in mean common carotid intimal-medial thickness
次要结局
- maximum carotid IMT progression(one year)
- carotid plaque score(one year)
研究者
Sun U. Kwon
Professor
Asan Medical Center