Simvastatin For Intracerebral Hemorrhage Study

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.

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)