Simvastatin For Intracerebral Hemorrhage Study
|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|
- Perihematomal edema [ Time Frame: Days 7 and 14 ] [ Designated as safety issue: No ]
- 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 ]
|Study Start Date:||October 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
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
Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00718328
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Neeraj S Naval, M.D.||Johns Hopkins University|