Clinical trial NCT00718328: Simvastatin For Intracerebral Hemorrhage Study
Official title: Simvastatin For Intracerebral Hemorrhage Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Intracerebral Hemorrhage
Keywords: Intracerebral
Hemorrhage
Edema
Statins
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: National Center for Research Resources (NCRR)
name: National Institutes of Health (NIH)
First posted: 2008-07-18
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Perihematomal Edema
timeFrame: Days 7 and 14
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Bayview Medical Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Neeraj S Naval, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Naval NS, Abdelhak TA, Zeballos P, Urrunaga N, Mirski MA, Carhuapoma JR. Prior statin use reduces mortality in intracerebral hemorrhage. Neurocrit Care. 2008;8(1):6-12. doi: 10.1007/s12028-007-0080-2.
citation: Naval NS, Abdelhak TA, Urrunaga N, Zeballos P, Mirski MA, Carhuapoma JR. An association of prior statin use with decreased perihematomal edema. Neurocrit Care. 2008;8(1):13-8. doi: 10.1007/s12028-007-0081-1.