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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00235963
First Posted: October 12, 2005
Last Update Posted: October 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Brigham and Women's Hospital
  Purpose
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
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

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


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Brigham and Women's Hospital
Investigators
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
First Submitted: October 7, 2005
First Posted: October 12, 2005
Last Update Posted: October 16, 2008
Last Verified: October 2008

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