Drug Research Study for Patients at Risk for Heart Disease

Study Summary

The University of Chicago and Dr. Matthew Sorrentino are conducting a research study that involves an experimental drug. This study focuses on people who are 55 years of age or older and have a specific combination of other risk factors that can effect the health of your heart and blood vessels. The purpose of this research study is to see whether an experimental drug can help lower the chances of your having a heart attack, a stroke, or of your dying from a heart attack or stroke.

This is a randomized (like a flip of a coin), placebo controlled, double blind study. Neither you nor your doctor will know if you get study drug or placebo (a substance that does not contain drug, like a sugar pill) during the study.

The duration of your participation depends on whether you are enrolled at the beginning, middle, or at the end of the study, as described above. The longest duration is expected to be 50 months (just over four years).

You will be screened to see if you qualify for participation. If you do, you will be randomized to study drug or placebo ("sugar pill"). After starting the study pills, you will be asked to see your study doctor at one month, three months, six months, and then every six months to the last visit at the end of the study. The study staff will contact you by telephone at months nine, 15, 21, 27, 33, 39, and 45, so they can better follow your medical condition between each of the office visits. Some of the procedures that may be done during the study include physical exams, blood tests, pregnancy test, electrocardiogram (test that measures the electrical activity of your heart), and neurological and psychiatric questionnaires.

Benefits

There is a chance that you will not any experience benefits from receiving the study drug. During this study you may benefit from medical follow-up of your conditions. You and your doctor may learn about possible conditions from your blood tests and ECGs. You will receive counseling on diet, exercise, and, if needed, stopping smoking. You may not lose weight. Although the study drug has helped some subjects in other studies lose weight, some of the good changes in blood sugar and lipids did not seem to be caused by weight loss. For this reason, you may receive some benefit in blood sugar and lipids from the study drug even if you do not lose weight. Your participation in this research study may provide important new information about the effects of the study drug.

Participation Details

Initial selection criteria include:

• Must be age 55 years or older
• Must have certain risks factors for cardiovascular (heart and blood vessels) disease
• Females of child-bearing potential must have a negative pregnancy test in order to participate.
• Must be available for clinic visits for the duration of the study
• Must meet study medical criteria as evaluated by Dr. Sorrentino

Study Director: Dr. Matthew Sorrentino
Department: Cardiology

For more information contact:
ebayer@medicine.bsd.uchicago.edu
(773) 702-0347

IRB: #14549B