Simvastatin For Intracerebral Hemorrhage Study

• Status: Terminated
• Trial end date: 2009-06-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johns Hopkins University
• Collaborators: National Center for Research Resources (NCRR); National Institutes of Health (NIH)
• Treatments: Simvastatin

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)