Simvastatin For Intracerebral Hemorrhage Study

Terminated

Phase 2 Results

Trial Description

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).

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.

Trial Stopped: Poor recruitment, trial terminated

Conditions

Interventions

  • Simvastatin Drug
    Intervention Desc: HMG-CoA reductase inhibitor; lowers cholesterol
  • Placebo Drug
    Intervention Desc: Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
    ARM 1: Kind: Experimental
    Label: II
    Description: Placebo Group
  • Simvastatin 80 mg Drug
    Intervention Desc: Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
    ARM 1: Kind: Experimental
    Label: I
    Description: Simvastatin Group

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Patient Involvement

Patients are randomized to receive either generic simvastatin 80 mg or placebo for 14 days or until death or discharge.

Outcomes

Type Measure Time Frame Safety Issue
Primary Perihematomal edema.
Secondary 30 day Mortality; 90 day Functional outcomes using Modified Rankin Score, Barthel Index.
Primary Perihematomal edema Days 7 and 14 No
Secondary Mortality 30 days No
Secondary Functional outcomes using Modified Rankin Score, Barthel Index 90 days No

Sponsors