EXACT 2 (Angina Associated with Coronary Artery Disease) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if an experimental drug called XC001 (the study drug) is an effective option for people who have angina that is caused by coronary artery disease. We want to know if the study drug can provide relief when common, approved therapies have failed to do so.
The study drug is made using an adenovirus (one of the causes of the common cold). The adenovirus in the study drug is genetically altered so it is able to deliver a protein called VEGF (vascular endothelial growth factor) to the heart and potentially spur the growth of new blood vessels.
Angina Caused By Coronary Artery Disease
Who Can Participate in the Study?
Adults age 18-85 who:
- Are diagnosed with chronic angina due to obstructive coronary artery disease
- Have not had a heart attack less than 60 days before joining the study
- Are not receiving the adequate or expected relief from angina symptoms after using standard therapies
For more information, contact the study team at sarah.casalinova@duke.edu.
What is Involved?
If you choose to join the study, you will get a random assignment (like a coin flip) to either get the study drug or a placebo (inactive substance with no drug in it). The study drug/placebo are given through a catheter so that the study drug or placebo can be injected directly into heart muscle.
You will come to the study clinic for follow-up visits at the following times after you get the study drug/placebo:
- 7 days
- 1 meses
- 3 meses
- 6 meses
- 12 meses
During these follow-up visits, you will have blood draws, electrocardiograms, and exercise testing done.
Study Details
