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

Last updated: May 29, 2024
Sponsor: Ascension South East Michigan
Overall Status: Terminated

Phase

4

Condition

Stroke

Hemorrhage

Treatment

Placebo

Cilostazol 100 MG

Clinical Study ID

NCT04148105
1072359
  • Ages 18-100
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 CTscan

  • Consent for study participation

Exclusion

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 absolutecontraindication for cilostazol

  • Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g.stent-assisted coiling or flow-diverting stent obliteration of aneurysm)

Study Design

Total Participants: 19
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 4
Study Start date:
November 01, 2019
Estimated Completion Date:
May 26, 2023

Study 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.

Connect with a study center

  • Ascension Providence Hospital

    Southfield, Michigan 48075
    United States

    Site Not Available

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