News | July 10, 2007

St. Jude Medical Announces First Enrollment in Anti-Clotting Study

July 11, 2007- St. Jude Medical Inc. and the Duke Clinical Research Institute (DCRI) announced the first enrollment in a major study designed to better understand appropriate anti-clotting medication therapies for patients following implantation of tissue heart valves.
The study will gather extensive clinical evidence on the use of anti-coagulant and anti-platelet (blood-thinning) medication treatments to reduce the risk of clot formation in the early months after a tissue valve is implanted. It also will gather data on the incidence of clotting and bleeding experienced by patients during the six months after they receive a tissue valve.
Administered by the DCRI, the Anti-coagulation Strategy with Bioprosthetic Valves: Post-Operative Event Registry (ANSWER) will enroll at least 2,000 patients at 100 U.S. medical centers. Enrollment is expected to be completed over the next two years.
When complete, the ANSWER Registry is expected to provide the largest body of prospective clinical evidence, to date, on anti-clotting therapies prescribed following implantation of tissue valves. The ANSWER Registry will collect data from consenting adult patients who are receiving their first aortic and/or mitral valve replacement and are implanted with a St. Jude Medical Biocor or Biocor Supra Stented Tissue Valve. Similar clinical evidence is being collected in European centers through the ACTION Registry (Anticoagulation Treatment Influence on Postoperative Patients), initiated in 2006 and conducted by St. Jude Medical.

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