Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
| Status: | Terminated |
|---|---|
| Conditions: | Neurology |
| Therapuetic Areas: | Neurology |
| Healthy: | No |
| Age Range: | 18 - 85 |
| Updated: | 4/21/2016 |
| Start Date: | May 2007 |
| End Date: | June 2009 |
Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
The purpose of this study is to test whether treatment with a drug called Simvastatin
prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is
currently approved for the treatment of high cholesterol levels.
prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is
currently approved for the treatment of high cholesterol levels.
Aneurysmal Subarachnoid hemorrhage or SAH (bleeding on the surface of the brain) affects 10
per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing
of the blood vessels (vasospasm) and related delayed strokes are the most common serious
complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite
maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke.
Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH,
this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients
enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80
mg per mouth daily), while the control group will receive a sugar tablet. The treatment will
be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures,
these are included with the application for your review) at day 21 post aSAH will be
reviewed at time of discharge as well at 6 months of follow up.
per 100,000 population each year. For survivors of the initial hemorrhage, delayed narrowing
of the blood vessels (vasospasm) and related delayed strokes are the most common serious
complication. Narrowing of blood vessels affect 30% of patients with such bleeding. Despite
maximum therapy, nearly 50% of patients with symptomatic vasospasm with develop stroke.
Because cerebral vasospasm remains the leading cause of morbidity and mortality after aSAH,
this critically important issue needs further studies.
One hundred and fifty patients will be randomized, 50 to each arm of the study. Patients
enrolled in the study will be receive the drug (either Simvastatin 40 mg or Simvastatin 80
mg per mouth daily), while the control group will receive a sugar tablet. The treatment will
be continued for a total of 21 days. The neurological abilities (Stroke Outcome measures,
these are included with the application for your review) at day 21 post aSAH will be
reviewed at time of discharge as well at 6 months of follow up.
Inclusion Criteria:
- 18-85 years old inclusive
- Subarachnoid hemorrhage diagnosed by CT on admission
- Randomizable within 732 hours of subarachnoid hemorrhage
- Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic
angiography (CTA)
- Surgical or endovascular obliteration
- Able to obtain written informed consent from patient or surrogate
Exclusion Criteria:
- Pregnancy, as confirmed by routine urine test on admission
- Elevated liver function test at time of randomization, defined as more than three
times the upper limit of normal
- On Statins, niacin, or fibrate therapy within 30 days of presentation
- Any vasospasm on the initial diagnostic angiogram
- Glasgow Coma Scale 5 or less at the time of randomization
- History of liver disease or active liver disease
- Hypersensitivity to statins
- Patient taking medication not recommended for concomitant use with Simvastatin (40 or
80 mg) as per the product label
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