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

This study has been completed.
Sponsor:
Information provided by:
Brigham and Women's Hospital
ClinicalTrials.gov Identifier:
NCT00235963
First received: October 7, 2005
Last updated: October 14, 2008
Last verified: October 2008
History of Changes
  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
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:

Drug Information available for: Simvastatin
U.S. FDA Resources

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Brigham and Women's Hospital

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

ClinicalTrials.gov processed this record on May 16, 2013