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Simvastatin For Intracerebral Hemorrhage Study

This study has been terminated.
(Poor recruitment, trial terminated)
Sponsor:
Collaborators:
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
Information provided by (Responsible Party):
Neeraj Naval, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00718328
First received: July 15, 2008
Last updated: December 14, 2011
Last verified: December 2011
History of Changes
  Purpose

Study Objective: To analyze if statins are effective in ameliorating perihematomal edema evolution thereby reducing mortality and improving functional outcomes following spontaneous intracerebral hemorrhage (ICH).


Condition Intervention Phase
Intracerebral Hemorrhage
 Drug: Simvastatin 80 mg
Drug: Placebo
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Simvastatin For Intracerebral Hemorrhage Study

Resource links provided by NLM:

MedlinePlus related topics: Edema Statins
Drug Information available for: Simvastatin
U.S. FDA Resources

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Perihematomal edema [ Time Frame: Days 7 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mortality [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Functional outcomes using Modified Rankin Score, Barthel Index [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Enrollment: 1
Study Start Date: October 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: I
Simvastatin Group
 Drug: Simvastatin 80 mg
Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
Placebo Comparator: II
Placebo Group
 Drug: Placebo
Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Detailed Description:

Intracerebral hemorrhage (ICH) causes 10% to 15% of first-ever strokes, with a 30-day mortality rate of 35% to 52% with only 20% expected to be functionally independent at 6 months. No medical or surgical interventions have been found to alter the natural evolution of this disease. The high risk for mortality and poor outcomes seems to occur despite relatively small hematoma volumes and small amounts of neuronal tissue at risk for injury. The reasons for this observation remain unknown; however perihematomal edema formation and inflammation that follows ICH seems to play an important role.

The Simvastatin for Intracerebral Hemorrhage Study is a prospective double blinded placebo controlled randomized (1:1) clinical trial that compares outcomes in patients receiving generic simvastatin 80 mg for 14 days or until death or discharge with patients in the placebo group.

The hypothesis for our study is that statins ameliorate perihematomal edema evolution thereby reducing mortality and improving functional outcomes following Intracerebral Hemorrhage (ICH). This hypothesis in turn is based on animal data showing suppression of inflammatory reaction and improved neurological outcomes following administration of statins to rodents with experimental ICH, and on a retrospective review of patients admitted to The Johns Hopkins Hospital over the last 7 years with spontaneous ICH which showed significantly better outcomes (decreased 30 day mortality secondary to decreased perihematomal edema) in patients on statins at the time of admission.

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

Exclusion Criteria:

  • Age < 18 or > 85
  • Admission GCS < 6
  • ICH volume < 10 cc
  • ICH secondary to trauma, aneurysm, AVM, tumor or post surgical
  • Multiple ICH
  • Associated Subdural hematoma or significant Subarachnoid hemorrhage
  • History of prior neurologic disease with mRS > 1
  • Hematoma evacuation, hemicraniectomy, clot lysis
  • Myopathy
  • Active Liver disease
  • Pregnancy
  • Statin allergy
  • Patients on statins prior to admission
  • Patients with an acute indication for statin therapy (Unstable angina)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718328

Locations
United States, Maryland
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
Investigators
Principal Investigator: Neeraj S Naval, M.D. Johns Hopkins Medical Institutions
  More Information

Publications:

Responsible Party: Neeraj Naval, MD, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00718328     History of Changes
Other Study ID Numbers: UL1-RR-025005, NIH UL1 RR 025005
Study First Received: July 15, 2008
Last Updated: December 14, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Johns Hopkins University:
Intracerebral
Hemorrhage
Edema
Statins

Additional relevant MeSH terms:
Hemorrhage
Cerebral 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 19, 2013