Status:
COMPLETED
A Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin on Subarachnoid Hemorrhage-Induced Vasospasm
Lead Sponsor:
Brigham and Women's Hospital
Conditions:
Subarachnoid Hemorrhage
Delayed Vasospasm
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.
Detailed Description
The mortality rate of aneurysmal subarachnoid hemorrhage (SAH) approaches 50% within the 1st 24 hours of ictus. Patients who survive can subsequently develop a progressive vasospasm of large cerebral ...
Eligibility Criteria
Inclusion
- Aneurysmal subarachnoid hemorrhage, Fisher Grade III.
- Patient or spouse or first degree relative able to give informed consent
- Age greater then 18
- Aneurysm secured surgically, or via endovascular technique
- Subject seen within 96 hours of bleeding
Exclusion
- Contraindication for the use of simvastatin
- Hunt-Hess Grade V
- Initial intracranial pressure over 30 cm H2O and sustained for more then 30 minutes
- Patient already on an HMG CoA-reductase inhibitor.
- Patients with severe chronic renal failure (creatinine \>3 and/or BUN \>40).
Key Trial Info
Start Date :
December 1 2002
Trial Type :
INTERVENTIONAL
End Date :
February 1 2006
Estimated Enrollment :
104 Patients enrolled
Trial Details
Trial ID
NCT00235963
Start Date
December 1 2002
End Date
February 1 2006
Last Update
October 16 2008
Active Locations (1)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114