Clinical Trial at Saint Louis University Examines How to Prevent Secondary Strokes
ST. LOUIS -- Saint Louis University is participating in the largest-ever study to compare the effectiveness of two medications in preventing stroke patients from having a second recurrence.
The PRoFESS (Prevention Regimen For Effectively Avoiding Second Strokes) study will recruit 15,500 patients from 24 countries who recently had ischemic strokes. About 80 percent of all strokes are ischemic strokes, which are caused by a blood clot that plugs an artery or blood vessel in the brain.
When a stroke occurs, brain cells in the immediate area die from lack of oxygen and nutrients they need to function. This can leave a patient with an assortment of disabilities including difficulties speaking, problems with thinking, pain, numbness or even paralysis.
"Patients who already had one stroke are at high risk of having a second stroke. They're going to be worse off with a second stroke, which increases the chance of cognitive decline and other disabilities," says Enrique Leira, M.D., assistant professor of neurology and study investigator at Saint Louis University School of Medicine.
"This research is exciting because we are comparing two well-known medications used to prevent second strokes to find out if one is more effective than the other. These two medications -- Aggrenox (dipyridamole plus aspirin) and Plavix (clopidogrel) -- are already well known to physicians and patients. We have years of experience with both of them, but we don't know if one is better than the other in preventing strokes."
Both Aggrenox and Plavix are antiplatelet medicines that keep blood clots from forming and help prevent more strokes. Aggrenox contains aspirin; Plavix does not. Volunteers who take Plavix also will receive aspirin.
The study also will examine whether patients who also take Micardis (telmisartan), a medication that lowers blood pressure, in addition to the stroke medications are less likely to have a secondary stroke than those who receive a placebo.
Doctors are trying to find out if adding a blood pressure medication to one of the two antiplatelet drugs could help reduce the risk of a recurrent stroke, even if a patient does not have high blood pressure, Dr. Leira says.
Saint Louis University is one of 517 study sites, and plans to enroll 30 volunteers.
Study participants will receive a physical and neurological examination, study medications and follow-up assessments by a neurologist every three months.
Eligible participants must be over 55 years old, neurologically and clinically stable, and have had an ischemic stroke within 90 days. Patients who have had hemorrhagic strokes -- which involve bleeding into the brain --, who have low blood pressure or uncontrolled hypertension, or are known to be hypersensitive to any of the medications tested are not eligible.
Volunteers will be randomly divided into groups and given various combinations of medications. They will receive free study medications and examinations by neurologists.
Established in 1836, Saint Louis University School of Medicine has the distinction of awarding the first M.D. degree west of the Mississippi River. Saint Louis University School of Medicine is a pioneer in geriatric medicine, organ transplantation, chronic disease prevention, cardiovascular disease, neurosciences and vaccine research, among others. The School of Medicine trains physicians and biomedical scientists, conducts medical research, and provides health services on a local, national and international level.
To learn more about the PRoFESS study at Saint Louis University, call 314.577.8738.
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