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Health Science Center researchers, physicians to lead new pilot trial
September 9, 2014

Dr. Marc Feldman, professor of medicine and engineering at the University of Texas Health Science Center at San Antonio, says participants in a new pilot trial program involving institutions in three states hope their findings will improve the delivery of care. Lester Rosebrock/University of Texas Health Science Center at San Antonio

By W. Scott Bailey, San Antonio Business Journal

Researchers and physicians at The University of Texas Health Science Center at San Antonio are leading a million-dollar pilot trial that could have a significant impact on how patients suffering from life-threatening peripheral vascular disease are treated. Stakeholders are seeking to determine whether drugs designed for heart attack survivors can also be used to help such patients.

The research will compare the clinical effects of two antiplatelet medications - ticagrelor and clopidogrel. Both drugs are designed to prevent platelets from collecting, thereby blocking clots that can cause heart attacks or strokes.

AstraZeneca, which markets ticagrelor, is funding the study at three sites: The Health Science Center, the University of Arkansas for Medical Sciences and the University of Alabama-Birmingham.

Peripheral arterial disease affects some 8 million Americans annually, according to the American Heart Association. Because its main symptoms are cramping in the thighs or calves, many people mistake the ailments for muscle or bone problems. The pain is actually the result of a blood-flow blockage due to plaque buildup.

San Antonio researchers and physicians collaborated with similar groups at UAMS and UAB to develop the idea for the pilot program, says Dr. Marc Feldman, professor of medicine and engineering in the Janey and Dolph Briscoe Division of Cardiology at the Health Science Center. They then reached out to AstraZeneca for funding.

A pair of cardiologists with UT Medicine in San Antonio, Dr. Hinan Ahmed and Dr. Anand Prasad, will determine whether patients who have lower limb pain caused by insufficient blood flow (claudication) and inadequate blood supply to the lower limb due to blocked blood vessels (ischemia) meet the criteria to be in the study. UT Medicine San Antonio is the clinical practice of the School of Medicine at the Health Science Center.

Forty patients at the three sites will have an initial catheterization, have a stent inserted, take part in one of two regimens of medicine and undergo a second catheterization. The patients will be divided into two randomly selected groups. One group will take ticagrelor and aspirin for six months. The other will take clopidogrel and aspirin the first month, followed by aspirin alone for months two through six.

The effect of the two medical therapies will be assessed by comparing blood clots seen by an imaging technique called optical coherence tomography, or OCT, which will be performed at the three sites and then sent to the core lab in San Antonio for analysis. The Health Science Center was one of the centers that helped commercialize this technique.

"OCT allows us to view the thickness and composition of arterial plaques," Feldman says. "It enables us to see the clot as a three-dimensional image."

OCT technology makes it possible to compare the effects of the two drug therapies, he said, adding that researchers hope to determine a drug combination that reduces patients' likelihood of future blood clots.

"Our goal is to improve their quality of life and ultimately reduce the number of hospitalizations," he says.

 

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