Amgen is teaming up with the Association of Black Cardiologists and Morehouse School of Medicine to run a study examining cardiovascular risk in African Americans.
The observational African American Heart Study will look at the association between lipoprotein(a), or Lp(a), and atherosclerotic cardiovascular disease, or ASCVD, in 5,000 African American participants in the U.S.
ASCVD occurs when plaque builds up in the arteries, causing them to thicken and harden. This reduces blood flow and can lead to coronary heart disease, stroke, heart attack, blood clots and other conditions. While cardiovascular disease is the leading cause of death in all Americans, African Americans have an even higher risk: they are 30% more likely to die from heart disease.
So Amgen is aiming to figure out what might contribute to that elevated risk. Lp(a) is considered to be a risk factor for heart disease and levels of the protein can differ based on race and ethnicity. African Americans are known to have higher average Lp(a) than white Americans. Nevertheless, research has mostly focused on white people of European descent.
Principal investigator Elizabeth Ofili, M.D., said the heart study will help reveal which types of patients could benefit from future therapies. Ofili is also a professor of medicine at Morehouse School of Medicine.
The study will enroll 2,500 African Americans with ASCVD and 2,500 without the disease. Morehouse and the Association of Black Cardiologists will conduct outreach and find potential trial sites through the Health 360x Clinical Trial Network and Registry, which is a catalog of trusted providers funded by the National Institutes of Health.
Amgen unit deCODE Genetics will analyze and sequence the DNA, RNA, and protein markers from blood samples taken from each patient. The company plans to follow participants for three years, using the information to inform future trials and drug development.
“Increasing the diversity in our clinical trials is essential to achieving our ambition of serving all patients. This requires us to think differently than we have in the past about how we design and conduct our trials,” said Rob Lenz, M.D., Ph.D., senior vice president of global development at Amgen.