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

  • STATUS
    Recruiting
  • End date
    Oct 1, 2023
  • participants needed
    120
  • sponsor
    Ascension South East Michigan
Updated on 27 January 2021

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.

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.

Details
Condition Subarachnoid Hemorrhage, aneurysmal subarachnoid hemorrhage
Treatment Placebo, Cilostazol 100 mg
Clinical Study IdentifierNCT04148105
SponsorAscension South East Michigan
Last Modified on27 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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)
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