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Phase II Trial of Experimental Anti-Coagulant Reports Safety and Outcomes Data
Date:11/11/2008

e most commonly used anticoagulant, or anti-clotting medication, works on several aspects of the clotting process, including Factor X. Compared to rivaroxaban, warfarin seems to be slower to reach therapeutically effective levels in the body and it requires repeated blood testing of patients who take it, beginning with tests to ensure that the therapy has achieved the goal of reduced clotting speed, Gibson said. This is important because if their blood clots too quickly, it could lead to a stroke or heart attack; if it clots too slowly that could lead to bleeding, he explained.

The ATLAS ACS-TIMI 46 Trial is more than twice the size of the second-largest study. That study, APPRAISE, found a non-significant trend toward benefits and a clear dose-response with more bleeding events at higher doses, he said.

A Phase III trial, expected to enroll 16,000 patients randomized to twice a day doses of 2.5 mg or 5 mg of rivaroxaban for six months is expected to begin in December 2008.

Co-authors include Jessica L. Mega, M.D.; Christopher J. Hammett M.D.; Vasil Hricak M.D.; Pascual Bordes M.D.; Adam Witkowski M.D.; Valentin Markov M.D.; Paul Burton M.D.; and Eugene Braunwald M.D. who chaired the study. Individual author disclosures can be found on the abstract.

The study was sponsored by Bayer AG, Leverkusen, Germany and Johnson & Johnson Pharmaceutical Research & Development, Raritan, N.J.

Statements and conclusions of study authors that are presented at American Heart Association scientific meetings are solely those of the study authors and do not necessarily reflect association policy or position. The association makes no representation or warranty as to their accuracy or reliability. The association receives funding primarily from individuals; foundations and corporations (including pharmaceutical, device manufacturers and other companies) also make donations and fund specific association programs and events. The association has strict pol
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SOURCE American Heart Association
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