Aneurysmal Subarachnoid Hemorrhage, Cerebral Vasospasm
Conditions
Keywords
SAH, Vasospasm
Brief summary
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.
Detailed description
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.
Interventions
Comparing two doses of Simvastatin to placebo
DRUGPlacebo
Placebo tablet
Comparing two doses of Simvastatin to placebo
Sponsors
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH | 21 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up | 6 months | Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Control Group Placebo tablet
Placebo: Placebo tablet | 2 |
| Study Group #1 Simvastatin 40 mg
Simvastatin: Comparing two doses of Simvastatin to placebo | 12 |
| Study Group #2 Simvastatin 80 mg
Simvastatin: Comparing two doses of Simvastatin to placebo | 11 |
| Total | 25 |
Baseline characteristics
| Characteristic | Control Group | Study Group #1 | Study Group #2 | Total |
|---|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 5.6 | 47 years STANDARD_DEVIATION 10.7 | 50 years STANDARD_DEVIATION 11.6 | 49 years STANDARD_DEVIATION 10.9 |
| Age, Customized 40-50 years | 0 participants | 6 participants | 4 participants | 10 participants |
| Age, Customized < 40 years | 0 participants | 2 participants | 1 participants | 3 participants |
| Age, Customized 50-60 years | 1 participants | 3 participants | 3 participants | 7 participants |
| Age, Customized 60-70 years | 1 participants | 0 participants | 1 participants | 2 participants |
| Age, Customized > 70 years | 0 participants | 1 participants | 2 participants | 3 participants |
| Race/Ethnicity, Customized Black | 0 participants | 3 participants | 4 participants | 7 participants |
| Race/Ethnicity, Customized Caucasian | 1 participants | 6 participants | 4 participants | 11 participants |
| Race/Ethnicity, Customized Hispanic | 1 participants | 3 participants | 3 participants | 7 participants |
| Region of Enrollment United States | 2 participants | 12 participants | 11 participants | 25 participants |
| Sex: Female, Male Female | 2 Participants | 8 Participants | 8 Participants | 18 Participants |
| Sex: Female, Male Male | 0 Participants | 4 Participants | 3 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
Outcome results
Primary
To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH
Time frame: 21 days
Population: Study PI left before outcome data was collected for the study and therefore the Outcome(s) will never be analyzed.
Secondary
To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up
Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.
Time frame: 6 months
Population: Study PI left before the efficacy of Simvastatin decreasing the incidence of clinical vasospasm in aSAH, and defining the optimal dose of Simvastatin and measuring the outcome at 6 months follow up data was collected for the study and therefore these outcomes will never be analyzed.