An International Drug Trial to begin at Brenner Children's Hospital
WINSTON-SALEM, N.C. – Pediatric researchers at Brenner Children’s Hospital will be testing a new medication to see if it helps children with congenital heart defects. Wesley Covitz, M.D., head of pediatric cardiology, and his team will test whether a drug can prevent a shunt, placed in the heart after a defect is discovered, from clotting.
The drug, called Clopidogrel, will be used to help patients who do not have enough blood flow to the lungs due to a heart defect. To treat this condition, a shunt is implanted surgically to keep the arteries open. If a clot forms in or around the shunt, it can be fatal, Covitz said. Approximately 490 patients who will enroll in the study will receive the drug or a placebo. All participants will also receive the currently approved treatment (aspirin therapy) to prevent clots from forming.
“We will follow these patients for a year to see if the drug reduces the likelihood of clotting, which is rare, but does occur,” he said. “The trial will include children from all over the world and who are less than three months of age.”
A variety of congenital heart defects require that a shunt be placed in a child’s heart to maintain or restore blood flow. A corrective operation is usually required when the child gets older and outgrows the existing shunt, Covitz said.
The drug, also know as Plavix, is commonly used in adults to prevent clotting. The manufacturer, Sanofi Aventis, is sponsoring the trial, which will begin enrolling patients in October.
For more information about the children’s hospital, visit www.brennerchildrens.org.
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Wake Forest University Baptist Medical Center is an academic health system comprised of North Carolina Baptist Hospital, Wake Forest University Health Sciences and Brenner Children’s Hospital. The system comprises 1,187 acute care, rehabilitation, psychiatry and long-term care beds and is consistently ranked as one of “America’s Best Hospitals” by U.S. News & World Report. Brenner Children’s was named one of the top children’s hospitals in the nation by Child magazine.
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