The Lipid Research Clinic at University of Iowa College of Public Health is conducting a research study to find out whether an investigational medication that reduces inflammation can prevent heart attacks or strokes in people who already have heart disease.
Jennifer Robinson, MD, PhD, medicine program director of the Lipid Research Clinic at University of Iowa College of Public Health, talks about the prevention study:
What role does inflammation have in preventing heart attacks and strokes?
Heart attacks and strokes are the result of a number of processes in the arteries of the body.
First, cholesterol has to clog the arteries, and those cholesterol blockages are called plaques. What can happen is the plaques can suddenly rupture and the ruptured plaque—a blood clot forms on top and tries to seal up that cracked plaque. It’s really the blood clot suddenly blocking the artery that results in a heart attack or stroke. We know that we can lower cholesterol, and aspirin causes a smaller blood clot. What we’d really like to do is decrease the inflammation because it can cause the plaque to grow in the first place, and also results in the plaque becoming unstable and rupturing. If we can block inflammation, we should be able to prevent the heart attacks and strokes from happening.
What will the prevention study look at in patients with a history of stoke or heart disease?
We’ll look at a new drug that blocks the action of a specific inflammatory agent in the blood—it’s called Lp-PLA2 for short. Studies have shown that blocking Lp-PLA2 will stabilize the cholesterol plaques in a way that should help to keep them from rupturing and causing a heart attack or stroke.
Who qualifies to participate in the study?
Anybody who’s had a heart attack or heart surgery—like a bypass or who has had a stent or balloon angioplasty—may qualify.
Are there age or health limitations that may prevent someone from participating in the study?
They just need to be 18 years or older, there’s no upper age limit. People who have severe asthma, who are on a number of medications, or a history of severe allergic reactions should not participate.
What will study participants be asked to do as part of the research study?
We’ll ask them to come in fasting for the study visits. We draw blood periodically through the study. Eligible patients will be assigned to a treatment group and they’ll either take the study medication or a matching placebo so we can determine if the new drug has any benefits.
What medical screenings and supplies will qualified study participants receive as part of the research?
People will receive lab work, physical exams, EKGs or electrocardiograms, and the study medication.
How long will the heart attack and stroke prevention study last?
We think it will last about three years.
Will participants be asked to stay with the study for the entire duration?
We ask them to come in for the study visits until the research is completed, although if safety issues come up or the study medication needs to be stopped, people no longer have to come into the clinic, we can just follow them up by telephone.
If someone wanted to learn more about the study, who should they contact?
They should call us at the Lipid Research Clinic at the University of Iowa, at 800-887-6917 or 319-384-5046. |