Efficacy and Safety of Cilostazol-Nimodipine Combined Therapy on Delayed Cerebral Ischemia After Aneurysmal Subarachnoid Hemorrhage (aSAH): A Prospective, Randomized, Double-Blinded, Placebo-Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Delayed Cerebral Infarction
研究概览
简要总结
The investigators seek to demonstrate that the combined use of cilostazol and nimodipine will significantly decrease the rate of delayed cerebral infarction and cerebral vasospasm after cerebrovascular intervention when compared to nimodipine alone.
详细描述
This research study is for people who have a brain hemorrhage, due to a ruptured aneurysm. Adding the drug cilostazol to the standard care may improve outcomes after surgery. The blood within the brain following aneurysmal hemorrhage can have harmful effects on the blood vessels causing them to narrow and thus decrease blood flow; this process is called vasospasm. Decreased blood flow in the brain can lead to more damage. Delayed cerebral ischemia is a complication which is believed to be a consequence of reduced blood flow to the brain following this type of hemorrhage. Cilostazol opens blood vessels and reduces the formation of blood clots. The standard treatment of these hemorrhages currently involves the use of nimodipine which also relaxes blood vessels and allows blood to flow more freely. The combination of these two drugs cilostazol and nimodipine may improve neurologic outcomes after surgery.
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)
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or older
- •Anterior circulation aneurysm
- •Patients who have undergone surgical intervention
- •Absence of rebleeding or new intracranial hemorrhage noted on post-intervention CT scan
- •Consent for study participation
排除标准
- •Non-aneurysmal subarachnoid hemorrhage
- •Multiple ruptured aneurysms
- •Patients with congestive heart failure
- •Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V)
- •Active pathological bleeding
- •Allergy to cilostazol
- •Positive pregnancy test
- •Coagulopathy not caused by anti-coagulant use
- •History of hemorrhagic complications (gastrointestinal bleeding, etc)
- •Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol
- •Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)
研究组 & 干预措施
Placebo
Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway.
干预措施: Placebo (Other)
Experimental
Administer 100 mg cilostazol, twice daily for 14 days. In addition, implement the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days, and the standard aneurysmal subarachnoid treatment pathway.
干预措施: Cilostazol 100 MG (Drug)
结局指标
主要结局
Delayed Cerebral Infarction
时间窗: 1 month (+/- 7 days) postoperatively
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
次要结局
- Symptomatic Cerebral Vasospasm(At any point leading up to 14 days post-operation)
- Radiographic Vasospasm(Between 7-10 days postoperatively)