Simvastatin For Intracerebral Hemorrhage Study

Phase 2

Terminated

• Conditions: Intracerebral Hemorrhage
• Interventions: Drug: Simvastatin 80 mg; Drug: Placebo

• Registration Number: NCT00718328
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study First Submitted: 2008-07-15
• Study First Submitted QC: 2008-07-16
• Study First Posted: 2008-07-18
• Study Start: 2008-10
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Results First Submitted: 2017-05-07
• Results First Submitted QC: 2017-05-07
• Results First Posted: 2017-06-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-08
• Last Update Posted: 2017-10-09

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

• Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
I	Simvastatin 80 mg	Simvastatin Group
II	Placebo	Placebo Group

Primary Outcome Measures

Name	Time	Method
Perihematomal Edema	Days 7 and 14	Solitary patient lost to follow up (out of state)

Trial Locations

Locations (1)

Johns Hopkins Bayview Medical Center; 🇺🇸 Baltimore, Maryland, United States