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

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ClinicalTrials.gov Identifier: NCT00235963
Recruitment Status : Completed
First Posted : October 12, 2005
Last Update Posted : October 16, 2008
Sponsor:
Information provided by:
Brigham and Women's Hospital

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

Condition or disease Intervention/treatment Phase
Subarachnoid Hemorrhage Delayed Vasospasm Drug: Simvastatin Phase 1 Phase 2

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Enrollment : 104 participants
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
Study Start Date : December 2002
Actual Primary Completion Date : January 2006
Actual Study Completion Date : February 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding
Drug Information available for: Simvastatin





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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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).

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

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 Posted: October 12, 2005    Key Record Dates
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