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Mount Sinai stroke prevention trial published in JAMA

tion of the study in JAMA adds to the body of evidence about the potential of this therapy," said Jonathan L. Halperin, M.D., Professor of Medicine and Director of Cardiology Clinical Services at the Zena and Michael A. Wiener Cardiovascular Institute and the Marie-Jose and Henry R. Kravis Center for Cardiovascular Health at The Mount Sinai Medical Center. "Clinicians see a major unmet medical need among patients with atrial fibrillation, who would benefit from access to new treatment options. The medical community will continue to work to safely bring to market new therapies that protect those at risk of stroke, without the drawbacks of existing therapies."

SPORTIF V was one of two Phase III clinical trials involving 7,329 patients. SPORTIF III, an open-label trial previously conducted outside North America, found that patients taking ximelagatran experienced no more strokes or bleeding than those on well-controlled warfarin.

In SPORTIF V, 63 patients receiving ximelagatran experienced major bleeding events compared to 84 patients in the warfarin arm (p=0.155). Six percent of patients treated with ximelagatran experienced an increase of a liver enzyme called ALT to greater than three times the upper limit of normal, compared to 0.8 percent of patients in the warfarin group. Although nearly all enzyme changes occurred within the first six months of treatment with ximelagatran and decreased either with or without drug discontinuation, a few patients developed more severe liver reactions.

About Atrial Fibrillation

Atrial Fibrillation (AF) is a common irregular heartbeat that occurs when the two small upper chambers of the heart (known as the atria) beat rapidly and unpredictably, which sometimes allows blood to pool and clot. If a section of the blood clot breaks off and travels to an artery in the brain, a stroke may result. AF affects more than two million Americans, and this number is expected to more than double by 2050
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Contact: Mount Sinai Press Office
NewsMedia@mountsinai.org
212-241-9200
The Mount Sinai Hospital / Mount Sinai School of Medicine
8-Feb-2005


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