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Simvastatin For Intracerebral Hemorrhage Study

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ClinicalTrials.gov Identifier: NCT00718328
Recruitment Status : Terminated (Poor recruitment, trial terminated)
First Posted : July 18, 2008
Results First Posted : June 12, 2017
Last Update Posted : October 9, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Intracerebral Hemorrhage Drug: Simvastatin 80 mg Drug: Placebo Phase 2

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.


Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Simvastatin For Intracerebral Hemorrhage Study
Study Start Date : October 2008
Primary Completion Date : June 2009
Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

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

Arms and Interventions

Arm Intervention/treatment
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.


Outcome Measures

Primary Outcome Measures :
  1. Perihematomal Edema [ Time Frame: Days 7 and 14 ]
    Solitary patient lost to follow up (out of state)


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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 Glasgow Coma Score (GCS) < 6
  • ICH volume < 10 cc
  • ICH secondary to trauma, aneurysm, Arterio-Venous Malformation (AVM), tumor or post surgical
  • Multiple ICH
  • Associated Subdural hematoma or significant Subarachnoid hemorrhage
  • History of prior neurologic disease with modified Rankin Scale (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

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): 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 University
More Information

Publications:
Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00718328     History of Changes
Other Study ID Numbers: NA_00016284
NIH UL1 RR 025005
First Posted: July 18, 2008    Key Record Dates
Results First Posted: June 12, 2017
Last Update Posted: October 9, 2017
Last Verified: September 2017

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
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors