Drug Research Study for Heart Patients
Study Summary
The University of Chicago and Dr. John Lopez are conducting a research study for subjects who have coronary atherosclerosis (hardening of the blood vessels that supply the heart) that requires having a procedure to restore the blood flow in the blood vessels of the heart (a percutaneous coronary intervention [PCI]). One complication that can occur after a PCI procedure is blood clotting and narrowing of the artery in the area that was treated. This can result in a decrease in the blood flow to heart. To avoid this complication, patients are given blood-thinning drugs as part of their routine care before, during and after this procedure. The purpose of this study is to compare the effects of an experimental drug with an FDA approved drug in subjects who are having a PCI procedure. An experimental drug is a drug that has not been approved by the US Food and Drug Administration (FDA).
For the purposes of this study, you will be assigned to one of two groups. One group will receive the experimental drug and the other group will receive usual care with an FDA approved drug. During your hospitalization for the PCI procedure, you will need to have a total of three ECGs (test to monitor the electrical activity of your heart) and approximately seven blood samples (about 16 teaspoons) taken for the study. You will be in this study for approximately one year after your PCI procedure. You will receive follow-up phone calls at approximately two days (if you are no longer in hospital), one month and again at one year after your procedure to check your condition.
Benefits
You may not benefit directly from this research if, for example, the experimental drug does not work. You may benefit if the experimental drug proves to be safer and/or more effective than any other treatment you might have received. The information learned about the experimental drug and how it works may be helpful to patients with heart disease in the future.
Participation Details
Initial selection criteria include:
- Must be at least 18 years of age
- Must not be pregnant or breast feeding during the study
- Must have coronary atherosclerosis requiring PCI
- Must meet study medical criteria as evaluated by Dr. Lopez
Study Director: Dr. John Lopez
Department: Cardiology
For more information contact:
Charity Ball, RN
cball@medicine.bsd.uchicago.edu
(773) 834-8399
IRB: #15441B
