Simvastatin For Intracerebral Hemorrhage Study

Johns Hopkins University

Status and phase: Terminated; Phase 2

Conditions: Intracerebral Hemorrhage

Treatments: Drug: Simvastatin 80 mg; Drug: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00718328

NA_00016284

NIH UL1 RR 025005

Details and patient eligibility

About

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).

Full 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.

Enrollment: 1 patient

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1 participants in 2 patient groups, including a placebo group

I

Experimental group

Description:

Simvastatin Group

Treatment:

Drug: Simvastatin 80 mg

II

Placebo Comparator group

Description:

Placebo Group

Treatment:

Drug: Placebo