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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 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
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)
  Show Detailed Description


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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 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 Identifier (NCT Number):
Responsible Party: Cenk Ayata, MD, Massachusetts General Hopital Identifier: NCT00235963     History of Changes
Other Study ID Numbers: 2002-P-000215
Study First Received: October 7, 2005
Last Updated: October 14, 2008

Additional relevant MeSH terms:
Subarachnoid Hemorrhage
Pathologic Processes
Intracranial Hemorrhages
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors processed this record on May 25, 2017