Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)
- Conditions
- Aneurysmal Subarachnoid Hemorrhage
- Interventions
- Other: Placebo
- Registration Number
- NCT04148105
- Lead Sponsor
- Ascension South East Michigan
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 19
- 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
- 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)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway. Experimental Cilostazol 100 MG 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.
- Primary Outcome Measures
Name Time Method Delayed Cerebral Infarction 1 month (+/- 7 days) postoperatively Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
- Secondary Outcome Measures
Name Time Method Symptomatic Cerebral Vasospasm At any point leading up to 14 days post-operation Development of a new focal or global neurological deficit or deterioration of at least 2 points on the Glasgow Coma Scale which was not explained by initial hemorrhage, re-bleeding, hydrocephalus, surgical complications, fever, infections, or electrolyte or metabolic disturbances; regardless of cerebral infarctions or angiographic vasospasm on imaging
Radiographic Vasospasm Between 7-10 days postoperatively Arterial narrowing not attributable to atherosclerosis, catheter-induced vasospasm, or vessel hypoplasia
Trial Locations
- Locations (1)
Ascension Providence Hospital
🇺🇸Southfield, Michigan, United States