Cilostazol for Prevention of Recurrent Stroke Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 1
- 主要终点
- Major adverse cardiovascular event (MACE)
研究概览
简要总结
The goal of this clinical trial is to learn whether adding cilostazol to aspirin or clopidogrel prevents stroke and heart attack in people who have had a stroke or mini-stroke.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Masked Statistician and Unmasked statistician.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of stroke or mini-stroke (also called TIA) within the last 180 days
- •Currently taking aspirin or clopidogrel (not both) to prevent another stroke
排除标准
- •Had a spontaneous brain bleed within the last 2 years.
- •Moderate to severe heart failure.
- •Life expectancy is less than 6 months.
研究组 & 干预措施
Cilostazol 100mg
Participants take oral cilostazol until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.
干预措施: Cilostazol 100 mg (Drug)
Placebo
Participants take oral placebo until a study endpoint occurs, they reach maximum follow up duration (4 years), the participant withdraws, or the study ends.
干预措施: Placebo (Drug)
结局指标
主要结局
Major adverse cardiovascular event (MACE)
时间窗: Up to 4 years after randomization
Time to stroke (ischemic and hemorrhagic), acute myocardial infarction, or vascular death
次要结局
- Ischemic stroke(Up to 4 years after randomization)
- Major hemorrhage(Up to 4 years after randomization)
研究者
Maarten Lansberg
Professor of Neurology
Stanford University