The Effect of Cilostazol Compared to Aspirin on Endothelial Function Measured by Flow Mediated Dilatation in Acute Cerebral Ischemia Patients
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- flow mediated dilation
研究概览
简要总结
Patients presenting with acute cerebral ischemic events are randomly assigned into aspirin (n=40) or cilostazol (n=40) group in a double-blinded manner. FMD is measured as a primary outcome at baseline (T0) and 90 days (T1). Serious and non-serious adverse events were described.
详细描述
This investigator-initiated, randomized, double-blind trial is prospectively conducted with two-arm parallel treatment groups and a single dose scheme: 100 mg aspirin daily and cilostazol placebo twice daily versus aspirin placebo daily and 100 mg cilostazol twice daily.
A total of 80 eligible patients is planned to be recruited.
All included patients undergo diagnostic studies including routine blood tests and cardiologic work-ups. The primary outcome is differences in endothelial function in the two groups measured by means of FMD on admission and at 3 months. According to previous studies, the adverse effects in two groups are investigated.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •acute ischemic stroke confirmed by diffusion weighted imaging
- •transient ischemic attack (TIA) within 7 days
排除标准
- •there is intracranial hemorrhage on imaging study
- •patients is previously taking antiplatelets, vitamin K antagonists, factor Xa antagonists, or chronic treatment with systemic steroidal and non-steroidal anti-inflammatory drugs
- •patients who received fibrinolytics within the previous 48 hours
- •cognitive impairment interfering with the possibility of obtaining informed consent
- •participation in another pharmacological study
- •peptic ulcer disease or hematological abnormality
- •initial modified Barthel index <30 points
- •liver function tests exceeding a 2-fold upper range value.
研究组 & 干预措施
cilostazol group
aspirin placebo daily and 100 mg cilostazol twice daily
干预措施: Cilostazol 100mg (Drug)
aspirin group
100 mg aspirin daily and cilostazol placebo twice daily
干预措施: Aspirin (Drug)
结局指标
主要结局
flow mediated dilation
时间窗: 3 month change
flow mediated dilation of the brachial artery in response to hyperemia
次要结局
未报告次要终点
研究者
Ji Man Hong
Associate proffessor
Ajou University School of Medicine