IRB Number:

08-003819

Trial Status:

Open for Enrollment

Phase: III

Why is this study being done?

A blood vessel abnormality called an aneurysm can cause a bleed within the head. The purpose of this trial is to study the potential benefits of giving a standard cholesterol lowering drug (called simvastatin) after a bleed has occurred. This is a licensed medication used regularly in the treatment for other vascular conditions including heart attacks and strokes, but it is not licensed at this stage for the treatment of a bleed in the brain.

Who is Eligible to Participate in the Study?

To be included in the study:
1. Patients aged 18-65 years in which the admitting neurosurgeon has confirmed evidence of an aneurysm, either by CT angiography, MR angiography or DSA
2. Time lapse from the time of the presenting bleed to randomization and initiation of trial medication does not exceed 96 hours.
3. Living independently prior to the SAH.

Exclusion Criteria
The presence of any of the following will preclude patient inclusion:
1. Already taking statin therapy.
2. Those taking Warfarin - type drugs.
3. Pregnancy.
4. Known renal or hepatic impairment
5. Suspected or known disease which threatens life expectancy
6. Known or strong suspicion of drug abuse, alcoholism, or those who are unlikely to be amenable to 6-month follow-up.
7. Those already taking amiodarone, verapamil or potent CYP3A4 inhibitor

What is Involved With this Study?

If you agree to be in the study, you will be asked to participate in the following:

You will have an interview with a study research coordinator. They will record information from your medical record including your vital signs (temperature, heart rate and respiratory rate) as well as information on what tests and procedures you received as part of your standard of care for your stroke.

Randomization Procedures for Study Medication:
You will be put in one of 2 groups by chance (as in the flip of a coin). One group will receive the study medication, simvastatin 40 mg. The other group will receive an inactive "dummy" drug called a placebo. You will have a 50/50 chance of receiving the study medication. You will take this medication once a day for up to 21 days. If you are discharged from the hospital before the 21st day, you will have the option to either continue taking the medication for the full 21 days, or stopping the medication upon being discharged. Nobody (even the doctors) will know which treatment is being given until the study is over. However, if necessary the doctor will be able to find out which treatment has been administered if any concern arises. Before leaving hospital a research coordinator will help to fill in a health questionnaire regarding your health. Similar questionnaires will be sent to your home 6 months later asking about the current state of health. We will ask you, or a care-giver if you are unable to, to complete these and send them back to the hospital in the stamped addressed envelope provided. We may need to call you to check on this process.

Some questions you will be asked to answer in the study health survey may make you feel uncomfortable. You may choose not to answer any questions that are uncomfortable to you.

The drug used in this study is considered investigational, which means it has either not been approved by the U.S. Food and Drug Administration (FDA) for routine clinical use or for the use described in this study. However the FDA has allowed the use of this drug/device in this research study. You will not pay for the medication.

You will have blood draws on recruitment and on days 3, 6, 9, and 12 after recruitment and on the day you are discharged from the hospital. Each blood drawn will be approximately 2 tablespoons of blood. These blood draws are done to monitor you while you are on the medication and the results of these tests will be recorded by the study coordinator. If you are discharged from the hospital prior to day 12, you will not have to complete the remaining scheduled blood draws.

How long will the Study run?

6 months

Who can I Contact for Additional Information on this Trial?

Alexa Richie, MPH, CCRP
904-953-7839
Richie.alexa@mayo.edu

What is/are the Locations of this Clinical Trial?

• Jacksonville, FL

Last updated: 04/03/2009