Simvastatin For Intracerebral Hemorrhage Study

Intracerebral Hemorrhage Clinical Trial

Official title:

Simvastatin For Intracerebral Hemorrhage Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00718328
• Other study ID #: NA_00016284
• Secondary ID: NIH UL1 RR 02500
• Status: Terminated
• Phase: Phase 2
• First received: July 15, 2008
• Last updated: September 8, 2017
• Start date: October 2008
• Est. completion date: June 2009

Study information

• Verified date: September 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage

Intervention

Drug:
• Simvastatin 80 mg
Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.
• Placebo
Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Locations

Country	Name	City	State
United States	Johns Hopkins Bayview Medical Center	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Center for Research Resources (NCRR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Perihematomal Edema	Solitary patient lost to follow up (out of state)	Days 7 and 14