Cilostazol and Aspirin in Acute Minor Stroke and Transient Ischemic Attack
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 378
- 试验地点
- 1
- 主要终点
- New stroke event for 90 days (Ischemic or hemorrhagic)
研究概览
简要总结
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin or to clopidogrel plus aspirin. The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis.
详细描述
This study is a randomized, open-labelled trial. We randomly assigned patients within 24 hours after the onset of minor ischemic stroke or high-risk TIA to combination therapy with cilostazol and aspirin (aspirin 100mg with cilostazol 200 mg for 21 days) or to clopidogrel plus aspirin (aspirin 100mg with clopidogrel 75mg for 21 days). The primary outcome was stroke (ischemic or hemorrhagic) during 90 days of follow-up in an intention-to-treat analysis. The primary safety outcome was the moderate-to-severe bleeding event according to (GUSTO) definition. The secondary outcomes were new clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes. Vascular death was defined as death due to stroke (ischemic or hemorrhagic), systemic hemorrhage, myocardial infarction, congestive heart failure, pulmonary embolism, sudden death, or arrhythmia.
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
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of an acute minor ischemic stroke or TIA
- •Acute minor stroke was defined by a score of 3 or less at the time of randomization on the National Institutes of Health Stroke Scale (NIHSS; scores range from 0 to 42, with higher scores indicating greater deficits)
排除标准
- •Intracerebral Hemorrhage
- •Brain tumor
- •Brain abscess, or other major non-ischemic brain disease;
- •Isolated sensory symptoms (numbness, isolated visual changes, or isolated dizziness or vertigo) without evidence of acute infarction on baseline CT or MRI of the head
- •A score of more than 2 on the modified Rankin scale, immediately before the occurrence of the index ischemic stroke or TIA, indicating moderate disability or worse at baseline
- •An NIHSS score of 4 or more at randomization
- •A clear indication for anticoagulation therapy (presumed cardiac source of embolus, such as atrial fibrillation or prosthetic cardiac valve) or a contraindication to clopidogrel, cilostazol or aspirin
- •History of intracranial hemorrhage
- •Anticipated requirement for long-term non-study antiplatelet drugs or for nonsteroidal anti-inflammatory drugs affecting platelet function
- •Heparin therapy or oral anticoagulation therapy within 10 days before randomization
- •Gastrointestinal bleeding or major surgery within the previous 3 months
- •Planned or probable revascularization (any angioplasty or vascular surgery) within 3 months after screening (if clinically indicated, vascular imaging was to be performed before randomization, whenever possible)
- •Planned surgery or interventional treatment requiring cessation of the study drug
- •TIA or minor stroke caused by angiography or surgery
- •Severe non- cardiovascular coexisting condition, with a life expectancy of less than 3 months
研究组 & 干预措施
aspirin with clopidogrel
aspirin 100mg with clopidogrel 75mg for 21 days
干预措施: Clopidogrel (Drug)
aspirin with cilostazol
aspirin 100mg with cilostazol 200 mg for 21 days
干预措施: Cilostazol (Drug)
结局指标
主要结局
New stroke event for 90 days (Ischemic or hemorrhagic)
时间窗: for 90 days
New stroke event for 90 days (Ischemic or hemorrhagic)
Moderate-to-severe bleeding event according to (GUSTO) definition
时间窗: for 90 days
Moderate-to-severe bleeding event according to (GUSTO) definition: Moderate : bleeding requiring transfusion Severe : Fatal or intracerebral bleeding, or bleeding resulting in substantial hemodynamic compromise requiring treatment
次要结局
- New clinical vascular event (ischemic or hemorrhagic stroke, myocardial infarction, or vascular death), analyzed as a composite outcome and also as individual outcomes.(for 90 days)
研究者
Taewon Kim
Principal Investigator
Incheon St.Mary's Hospital