Simvastatin For Intracerebral Hemorrhage Study
|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
|Condition or disease||Intervention/treatment||Phase|
|Intracerebral Hemorrhage||Drug: Simvastatin 80 mg Drug: Placebo||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Simvastatin For Intracerebral Hemorrhage Study|
|Study Start Date :||October 2008|
|Actual Primary Completion Date :||June 2009|
|Actual Study Completion Date :||June 2009|
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.
- Perihematomal Edema [ Time Frame: Days 7 and 14 ]Solitary patient lost to follow up (out of state)
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00718328
|United States, Maryland|
|Johns Hopkins Bayview Medical Center|
|Baltimore, Maryland, United States, 21224|
|Principal Investigator:||Neeraj S Naval, M.D.||Johns Hopkins University|