Simvastatin For Intracerebral Hemorrhage Study

NCT ID: NCT00718328

Last Updated: 2017-10-09

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31
• Study Completion Date: 2009-06-30

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.

Conditions

Intracerebral Hemorrhage

Keywords

Intracerebral; Hemorrhage; Edema; Statins

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

I

Simvastatin Group

Group Type: EXPERIMENTAL

Simvastatin 80 mg

Intervention Type: DRUG

Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.

II

Placebo Group

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Interventions

Simvastatin 80 mg

Patients in study arm 1 will receive simvastatin 80 mg once daily for 14 days or until death or discharge.

Intervention Type: DRUG

Placebo

Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Research Resources (NCRR)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neeraj S Naval, M.D.

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 17701108 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17701107 (View on PubMed)

Other Identifiers

NIH UL1 RR 025005

Identifier Type: -

Identifier Source: secondary_id

NA_00016284

Identifier Type: -

Identifier Source: org_study_id