Clinical trial NCT04148105: Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Aneurysmal Subarachnoid Hemorrhage
Keywords: Delayed cerebral ischemia
Cerebral vasospasm
Cilostazol
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2019-11-01
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Delayed Cerebral Infarction
timeFrame: Baseline
measure: Delayed Cerebral Infarction
timeFrame: 1 week (+/- 2 days) postoperatively
measure: Delayed Cerebral Infarction
timeFrame: 1 month (+/- 7 days) postoperatively
Secondary outcomes:
measure: Symptomatic Cerebral Vasospasm
timeFrame: At any point leading up to 14 days post-operation
measure: Radiographic Vasospasm
timeFrame: Between 7-10 days postoperatively
Other outcomes:
measure: Quality of Life Outcomes: Short-Form 12
timeFrame: Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively
measure: Modified Rankin Scale
timeFrame: Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively
Locations:
city: Southfield
country: United States
facility: Ascension Providence Hospital
state: Michigan
Study officials:
affiliation: Div of Neurosurgery Ascension Providence Hospital MSU College of Human Medicine
name: Boyd Richards, DO
role: PRINCIPAL_INVESTIGATOR
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