Patients with heart disease needed for drug trial
By Glenna Picton
Patients are being sought for a study to determine whether the as-yet unapproved drug called darapladib can reduce the risk of having a heart attack or stroke in people who already have heart disease.
Men and women who are being treated for heart disease are being asked to take part in the study at Baylor College of Medicine.
The study, called STABILITY (Stabilization of atherosclerotic plaque by initiation of darapladib therapy), will involve 15,000 patients around the world and between 50 and 100 in Houston.
Marker for heart disease?
Darapladib inhibits an enzyme called lipoprotein-associated phospholipase A2 (Lp-PLA2), which may provoke inflammation in the heart vessel wall and be a risk factor for causing heart disease. Doctors already test patients for levels of this enzyme because it is believed to be a marker for heart disease.
"We have conducted previous research that shows an association between high levels of Lp-PLA2 and an increased risk for heart attacks and strokes," said Christie Ballantyne, M.D., professor of medicine and director of The Center for Cardiovascular Disease Prevention at BCM, who will lead the study here.
Study criteria
Patients in the study will remain on their usual heart disease medicines, including statins to lower cholesterol, antiplatelet medications such as aspirin, ticlopidine and clopidgrel to reduce clotting and other medications to lower blood pressure or reduce heart rate. Some of those in the study will receive the experimental drug; others will receive a placebo, or inactive medicine.
The doctors hope to see whether inhibiting this enzyme could stabilize the fatty plaques in blood vessels. When these plaques become unstable and erupt, a heart attack or stroke can result.
To be eligible for this study, participants must:
- Be over the age of 18
- Have a diagnosis of coronary heart disease
- Have at least one other risk factor for heart disease, which includes age over 60, diabetes, low high-density lipoprotein (good cholesterol less than 40 mg/dL), smoking, kidney dysfunction or blockages in other parts of the body
- Already be on a statin for treatment of cholesterol
Medications
Study medication will be given to patients in addition to their heart medicine schedule. If you are taking medicines for other conditions, the study physician will discuss those with you.
For more information on enrollment, please call 713-798-3330.
The study is being sponsored by GlaxoSmithKline.
Heart disease is the leading cause of death for men and women in the United States.
