Ignite Creation Date:
2025-12-24 @ 12:58 PM
Ignite Modification Date:
2025-12-28 @ 9:32 PM
Study NCT ID:
NCT00487461
Status:
TERMINATED
Last Update Posted:
2015-11-25
First Post:
2007-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Sponsor:
University of Illinois at Chicago
Organization:
Study Overview
Official Title:
Randomized Double Blind Study Using Simvastatin for the PRevention Aof Vasospasm in Aneurysmal Subarachnoid Hemorrhage
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study PI left the institution and study was stopped at that time.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: