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

This study has been completed.
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
First received: October 7, 2005
Last updated: October 14, 2008
Last verified: October 2008
To determine whether HMG-CoA reductase inhibitor simvastatin prevents or ameliorates subarachnoid hemorrhage-induced delayed vasospasm and its ischemic consequences.

Condition Intervention Phase
Subarachnoid Hemorrhage
Delayed Vasospasm
Drug: Simvastatin
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Placebo-Controlled Trial of Simvastatin on Subarachnoid Hemorrhage-Induced Vasospasm

Resource links provided by NLM:

Further study details as provided by Brigham and Women's Hospital:

Estimated Enrollment: 104
Study Start Date: December 2002
Study Completion Date: February 2006
Primary Completion Date: January 2006 (Final data collection date for primary outcome measure)
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Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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).
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00235963

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital
Principal Investigator: Cenk Ayata, M.D. Massachusetts General Hospital
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Cenk Ayata, MD, Massachusetts General Hopital
ClinicalTrials.gov Identifier: NCT00235963     History of Changes
Other Study ID Numbers: 2002-P-000215 
Study First Received: October 7, 2005
Last Updated: October 14, 2008
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Brain Diseases
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Intracranial Hemorrhages
Nervous System Diseases
Pathologic Processes
Vascular Diseases
Anticholesteremic Agents
Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 26, 2016