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

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Brigham and Women's Hospital
• Treatments: Simvastatin

Criteria

Inclusion Criteria:

1. Aneurysmal subarachnoid hemorrhage, Fisher Grade III.

2. Patient or spouse or first degree relative able to give informed consent

3. Age greater then 18

4. Aneurysm secured surgically, or via endovascular technique

5. Subject seen within 96 hours of bleeding

Exclusion Criteria:

1. Contraindication for the use of simvastatin

2. Hunt-Hess Grade V

3. Initial intracranial pressure over 30 cm H2O and sustained for more then 30 minutes

4. Patient already on an HMG CoA-reductase inhibitor.

5. Patients with severe chronic renal failure (creatinine >3 and/or BUN >40).