Use of Simvastatin for the Prevention of Vasospasm in Aneurysmal Subarachnoid Hemorrhage

NCT00487461 | Terminated Results

• 1 other identifier: 2005-0857
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to test whether treatment with a drug called Simvastatin prevents and improves outcome in patients who have Subarachnoid bleeding. Simvastatin is currently approved for the treatment of high cholesterol levels.

Conditions

Aneurysmal Subarachnoid Hemorrhage; Cerebral Vasospasm

Keywords

SAH; Vasospasm

Outcome Measures

Primary Outcomes (1)

• To Measure Outcome in Patients Diagnosed With Aneurysmal Subarachnoid Hemorrhage (aSAH) Treated With Simvastatin, by Assessing Neurological Outcome by Accessing Glasgow Outcome Score, Modified Rankin Scale, and Barthel Index Score at Day 21 Post aSAH

  21 days

Secondary Outcomes (1)

• To Determine Efficiency of Simvastatin in Decreasing the Incidence of Clinical Vasospasm in aSAH, and Define the Optimal Dose of Simvastatin and to Measure Outcome at 6 Months Follow up

  6 months

Study Arms (3)

Control Group

PLACEBO COMPARATOR

Placebo tablet

Drug: Placebo

Study Group #1

EXPERIMENTAL

Simvastatin 40 mg

Drug: Simvastatin 40 mg

Study Group #2

EXPERIMENTAL

Simvastatin 80 mg

Drug: Simvastatin 80 mg

Interventions

Simvastatin 40 mg DRUG

Comparing two doses of Simvastatin to placebo

Also known as: Zocor

Study Group #1

Placebo DRUG

Placebo tablet

Also known as: dummy pill, sugar pill

Control Group

Simvastatin 80 mg DRUG

Comparing two doses of Simvastatin to placebo

Also known as: Zocor

Study Group #2

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old inclusive
• Subarachnoid hemorrhage diagnosed by CT on admission
• Randomizable within 732 hours of subarachnoid hemorrhage
• Saccular intracranial aneurysm proven by cerebral angiography or computed tomographic angiography (CTA)
• Surgical or endovascular obliteration
• Able to obtain written informed consent from patient or surrogate

You may not qualify if:

• Pregnancy, as confirmed by routine urine test on admission
• Elevated liver function test at time of randomization, defined as more than three times the upper limit of normal
• On Statins, niacin, or fibrate therapy within 30 days of presentation
• Any vasospasm on the initial diagnostic angiogram
• Glasgow Coma Scale 5 or less at the time of randomization
• History of liver disease or active liver disease
• Hypersensitivity to statins
• Patient taking medication not recommended for concomitant use with Simvastatin (40 or 80 mg) as per the product label

Sponsors & Collaborators

• University of Illinois at Chicago: lead

Study Sites (1)

Univeristy of Illinois at Chicago, Dept of Neurosurgery

Chicago, Illinois, 60612, United States

Location

MeSH Terms

Conditions

Subarachnoid Hemorrhage; Vasospasm, Intracranial

Interventions

Simvastatin; Sugars

Condition Hierarchy (Ancestors)

Intracranial Hemorrhages; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Lovastatin; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds; Carbohydrates

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed and Primary Physician leaving institution before study completion.

Results Point of Contact

• Title: Ali Alaraj, MD
• Organization: University of Illinois at Chicago

alaraj@uic.edu

312-996-4842

Study Officials

• Ben Z. Roitberg, MD

  Assnt Prof. Univ. of Illinois at Chicago, Dept of Neurosurgery

  PRINCIPAL INVESTIGATOR

• Ali Alaraj, MD

  Clinical Fellow Department of Neurosurgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 15, 2007
• First Posted: June 18, 2007
• Study Start: May 1, 2007
• Primary Completion: February 1, 2009
• Study Completion: June 1, 2009
• Last Updated: November 25, 2015
• Results First Posted: November 25, 2015

Record last verified: 2015-10

Locations

US (1)