Status:
TERMINATED
Simvastatin For Intracerebral Hemorrhage Study
Lead Sponsor:
Johns Hopkins University
Collaborating Sponsors:
National Center for Research Resources (NCRR)
National Institutes of Health (NIH)
Conditions:
Intracerebral Hemorrhage
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
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 hemo...
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 surg...
Eligibility Criteria
Inclusion
- Patient with CT evidence of ICH admitted within 24 hours of onset of symptoms.
Exclusion
- 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)
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2009
Estimated Enrollment :
1 Patients enrolled
Trial Details
Trial ID
NCT00718328
Start Date
October 1 2008
End Date
June 1 2009
Last Update
October 9 2017
Active Locations (1)
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1
Johns Hopkins Bayview Medical Center
Baltimore, Maryland, United States, 21224