Simvastatin For Intracerebral Hemorrhage Study

• ClinicalTrials.gov Identifier: NCT00718328
• Recruitment Status: Terminated
• First Posted: July 18, 2008
• Results First Posted: June 12, 2017
• Last Update Posted: October 9, 2017
• Sponsor: Johns Hopkins University
• Collaborators: National Center for Research Resources (NCRR); National Institutes of Health (NIH)
• Information provided by (Responsible Party): Johns Hopkins University

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Intracerebral Hemorrhage	Drug: Simvastatin 80 mg; Drug: Placebo	Phase 2

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 1 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Simvastatin For Intracerebral Hemorrhage Study
• Study Start Date: October 2008
• Actual Primary Completion Date: June 2009
• Actual Study Completion Date: June 2009

Arms and Interventions

Arm	Intervention/treatment
Experimental: I; Simvastatin Group	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 Comparator: II; Placebo Group	Drug: Placebo; Patients in study arm II will receive placebo once daily for 14 days or until death or discharge.

Outcome Measures

Primary Outcome Measures :

1. Perihematomal Edema [ Time Frame: Days 7 and 14 ]
   Solitary patient lost to follow up (out of state)

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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)

Contacts and Locations

Locations

United States, Maryland

Johns Hopkins Bayview Medical Center

Baltimore, Maryland, United States, 21224

Sponsors and Collaborators

Johns Hopkins University

National Center for Research Resources (NCRR)

National Institutes of Health (NIH)

Investigators

• Principal Investigator: Neeraj S Naval, M.D.; Johns Hopkins University

More Information

Publications:

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.

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.

• Responsible Party: Johns Hopkins University
• ClinicalTrials.gov Identifier: NCT00718328
• Other Study ID Numbers: NA_00016284; NIH UL1 RR 025005
• First Posted: July 18, 2008
• Results First Posted: June 12, 2017
• Last Update Posted: October 9, 2017
• Last Verified: September 2017

Keywords provided by Johns Hopkins University:

Intracerebral; Hemorrhage; Edema; Statins

Additional relevant MeSH terms:

Cerebral Hemorrhage; Hemorrhage; Pathologic Processes; Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Simvastatin; Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Lipid Regulating Agents; Hydroxymethylglutaryl-CoA Reductase Inhibitors; Enzyme Inhibitors