Simvastatin For Intracerebral Hemorrhage Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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Simvastatin For Intracerebral Hemorrhage Study

Conditions
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Intracerebral Hemorrhage

Intervention / Treatment
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* Drug: Simvastatin 80 mg
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br>Simvastatin Group | Drug: Simvastatin 80 mg<br>* Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.<br>|
| Placebo Comparator: II<br>Placebo Group | Drug: Placebo<br>* Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perihematomal Edema | Solitary patient lost to follow up (out of state) | Days 7 and 14 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intracerebral, Hemorrhage, Edema, Statins