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

Study highlights:

- Researchers present promising results from dose-ranging study of new oral anti-coagulant in patients with acute coronary syndrome.

- Phase III trial slated to begin in December.

NEW ORLEANS, Nov. 11 /PRNewswire-USNewswire/ -- Researchers reported on a study of a new oral anti-clotting agent -- rivaroxaban -- designed to identify doses that would be safe to test in subsequent Phase III efficacy and safety trials. The results of ATLAS ACS-TIMI 46 were presented as a late-breaking clinical trial at the American Heart Association's Scientific Sessions 2008.

"The goal of any early study is to find the right dose and the right way to give the drug, and we met that objective," said C. Michael Gibson, M.S., M.D., principal investigator, chief of clinical research at the Beth Israel Deaconess Medical Center and director of the Thrombolysis in Myocardial Infarction (TIMI) data coordinating center at Brigham and Women's Hospital, Boston, Mass. "We studied four different doses and both once-a-day and twice-a-day dosing schedules for this Factor Xa, (pronounced ten-A) inhibitor."

The Phase II, randomized, placebo-controlled study on 3,491 patients treated at 297 medical centers in 27 countries originally had safety as the primary endpoint, but its design also included efficacy endpoints, he said. The primary efficacy endpoint was a composite of death, heart attack, stroke and severe ischemia revascularization. The secondary endpoint was a composite of death, heart attack or stroke.

Earlier studies had shown the experimental drug rivaroxaban effective at keeping blood clots from forming in the veins during and after major orthopedic surgery. ATLAS ACS-TIMI 46 is the first test of the drug in the arteries -- which face higher pressures than the venous circulation -- and the first study of the drug in acute coronary syndrome, defined as a heart attack or unstable angina, said Gibson.

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SOURCE American Heart Association
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