Cilostazol and Nimodipine Combined Therapy After Aneurysmal Subarachnoid Hemorrhage (aSAH)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 4 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Implement standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway. |
Other: Placebo
The standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
|
| Experimental: Experimental 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. |
Drug: Cilostazol 100 MG
The addition of 100 mg cilostazol, twice daily for 14 days, to the standard treatment regimen of 60 mg nimodipine every 4 hours for 21 days and the standard aneurysmal subarachnoid treatment pathway
|
Outcome Measures
Primary Outcome Measures
- Delayed Cerebral Infarction [Baseline]
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
- Delayed Cerebral Infarction [1 week (+/- 2 days) postoperatively]
Ischemic lesions demonstrated on follow-up CT or MRI will be interpreted as new cerebral infarctions
- 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
- 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
Other Outcome Measures
- Quality of Life Outcomes: Short-Form 12 [Baseline, 1 month postoperatively, 3 month postoperatively, and 6 month postoperatively]
Short-Form 12 is answered by the patient. On a scale of 0-100, a higher score means better overall physical and mental health.
- Modified Rankin Scale [Baseline, 1 month postoperatively, 3 month postoperatively, 6 month postoperatively]
The patient's clinical status is graded on a scale of 0-6. An increasing score means a worse functional outcome.
Eligibility Criteria
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:
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Non-aneurysmal subarachnoid hemorrhage
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Multiple ruptured aneurysms
-
Patients with congestive heart failure
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Severe aneurysmal subarachnoid hemorrhage (Hunt Hess Grade V)
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Active pathological bleeding
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Allergy to cilostazol
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Positive pregnancy test
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Coagulopathy not caused by anti-coagulant use
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History of hemorrhagic complications (gastrointestinal bleeding, etc)
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Uncontrolled or severe comorbidity that would qualify as an absolute contraindication for cilostazol
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Patients requiring anticoagulant/antiplatelet treatment following intervention (e.g. stent-assisted coiling or flow-diverting stent obliteration of aneurysm)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ascension Providence Hospital | Southfield | Michigan | United States | 48075 |
Sponsors and Collaborators
- Ascension South East Michigan
Investigators
- Principal Investigator: Boyd Richards, DO, Div of Neurosurgery Ascension Providence Hospital MSU College of Human Medicine
Study Documents (Full-Text)
None provided.More Information
Publications
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- Allen GS, Ahn HS, Preziosi TJ, Battye R, Boone SC, Boone SC, Chou SN, Kelly DL, Weir BK, Crabbe RA, Lavik PJ, Rosenbloom SB, Dorsey FC, Ingram CR, Mellits DE, Bertsch LA, Boisvert DP, Hundley MB, Johnson RK, Strom JA, Transou CR. Cerebral arterial spasm--a controlled trial of nimodipine in patients with subarachnoid hemorrhage. N Engl J Med. 1983 Mar 17;308(11):619-24.
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