What we are studying
Events such as heart attack, stroke or the need for a revascularization procedure are signs of severe arterial disease. In general, patients who have experience arterial disease receive medications such as blood thinners, drugs to control blood pressure, lipid-lowering drugs and medication to control blood sugar if diabetic. Nevertheless, there remains a considerable risk of experiencing a repeat event. In this study, we will test whether or not the study drug, dalcetrapib can reduce the risk for another event. Subjects will continue to take all other prescribed medications during the study.
Genes hold the necessary instructions to develop all living organisms and are contained in DNA. Most of the DNA is identical between human beings but the small differences that we all have make individuals unique, for example our height or the color of our eyes. These types of differences could also explain why some people respond differently to the same drug.
Dalcetrapib, an investigational drug - not been approved by the U.S. FDA, has been evaluated in several large research studies, most notably dal-OUTCOMES. The results of this large study demonstrated that treatment with dalcetrapib did not change the risk of cardiovascular disease in the majority of subjects. However researchers identified a group of subjects that had a significant benefit: those with a particular AA variant of a gene that all humans share called ADCY9. Specifically, this group of subjects had their risk of having another cardiovascular event reduced by 39%. Approximately 1 in 5 subjects had this genetic variant.
The goal of the Dal-Gene study is to evaluate the effect of dalcetrapib only in subjects who have the AA genetic variant. .
Subjects will undergo a screening genetic test to determine if they have the AA genetic variant. Only those with the AA genetic variant can participate in the study. If the AA genetic variant is present and the subject meets all other study criteria, the treatment period with the study drug, dalcetrapib or placebo will begin. Subjects will be assigned by chance to dalcetrapib or placebo (a “dummy drug”). The study period ranges from 2.5 to 5 years depending on when the subject is enrolled. Subjects come to the clinic one month after starting the study drug and then approximately every 6 months until the study ends. Visit procedures include blood pressure, pulse and weight measurements at each visit; a physical exam at the second and last visits; and blood draws at the second and sixth visits.
Subjects will be paid $75 for each completed clinic visit.