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Simvastatin For Intracerebral Hemorrhage Study

This study has been terminated.
(Poor recruitment, trial terminated)
Sponsor:
Collaborators:
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

July 15, 2008
December 14, 2011
October 2008
June 2009   (final data collection date for primary outcome measure)
Perihematomal edema [ Time Frame: Days 7 and 14 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00718328 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Simvastatin For Intracerebral Hemorrhage Study
Simvastatin For Intracerebral Hemorrhage Study

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).

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Intracerebral Hemorrhage
  • Drug: Simvastatin 80 mg
    Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
  • Drug: Placebo
    Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
  • Experimental: I
    Simvastatin Group
    Intervention: Drug: Simvastatin 80 mg
  • Placebo Comparator: II
    Placebo Group
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
1
June 2009
June 2009   (final data collection date for primary outcome measure)

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)
Both
18 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00718328
UL1-RR-025005, NIH UL1 RR 025005
Yes
Neeraj Naval, Johns Hopkins University
Johns Hopkins University
  • National Center for Research Resources (NCRR)
  • National Institutes of Health (NIH)
Principal Investigator: Neeraj S Naval, M.D. Johns Hopkins University
Johns Hopkins University
December 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP