A Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin on Subarachnoid Hemorrhage-Induced Vasospasm

Completed · Phase 1/Phase 2

Conditions studied: Subarachnoid Hemorrhage, Delayed Vasospasm

In brief

To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.

Key facts

Study ID

NCT00235963

Run by

Brigham and Women's Hospital

People needed

104

Starts

2002-12-01

Expected to finish

2006-02-01

Last updated by the study team

2008-10-16

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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).

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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