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

he regimen of patients who were already taking either aspirin or aspirin plus a thienopyridine. Regarding the safety endpoint, a composite of TIMI major bleeding, TIMI minor bleeding and any bleeding requiring medical attention, the researchers found that bleeding incidents increased with increasing doses of rivaroxaban. Bleeding ranged from 6.1 percent of patients receiving 5 milligrams (mg) of the drug each day to 15.3 percent of those receiving 20 mg daily compared to a 3.3 percent rate of bleeding incidents in patients receiving placebo, he said. Overall, 82 percent of all bleeding incidents fell in the mildest, non-TIMI tier of severity, he added.

The study reported no significant risk reduction (p=0.10) for rivaroxaban patients compared to placebo patients for the primary efficacy composite endpoint of all-cause death, heart attack, stroke and severe recurrent chest pain (ischemia) requiring revascularization with bypass surgery or angioplasty. It did report a significant risk reduction for treated vs. placebo patients for the secondary efficacy composite endpoint of death, heart attack or stroke and that finding did reach statistical significance (p=0.028), he said.

The study followed patients being treated for ACS who were first divided into two strata depending on what usual care they received at their home medical center, he explained. Patients receiving aspirin entered Stratum I (706 patients) while those receiving aspirin plus a thienopyridine entered Stratum II (2,731 patients). All patients then had either placebo or one of four total daily doses of the Factor Xa inhibitor on a once- or twice-a-day schedule added to their regimen.

Aspirin and thienopyridines are anti-clotting agents that interfere with platelet aggregation, which is the clumping together of these blood cells. Factor Xa inhibitors interfere with formation of the fine threads of thrombin that bind the platelets together into a blood clot, he said.

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SOURCE American Heart Association
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