Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)

Ascension South East Michigan

Status and phase: Terminated; Phase 4

Conditions: Aneurysmal Subarachnoid Hemorrhage

Treatments: Other: Placebo; Drug: Cilostazol 100 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT04148105

1072359

Details and patient eligibility

About

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.

Full 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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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19 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway.

Treatment:

Other: Placebo

Experimental

Experimental group

Description:

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.

Treatment:

Drug: Cilostazol 100 MG