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Schering-Plough's Investigational Oral Thrombin Receptor Antagonist Meets Primary Endpoint in a Newly Published Study
Date:3/12/2009

percent with TRA (43 percent reduction).

TRAP-induced platelet aggregation inhibition was also measured. In those receiving the three oral loadings doses, platelet inhibition of greater than or equal to 80 percent was seen in 42.9 percent, 52.9 percent and 96.3 percent of study patients at each respective dose 120 minutes post-TRA administration. In maintenance doses, inhibition greater than or equal to 80 percent was seen in 90.9 percent, 100 percent and 100 percent of patients at each respective dose at 30 and 60 days compared to 9.1 and 11.1 percent at 30 and 60 days for patients receiving standard of care.

About the Phase III Trials

TRA is currently being evaluated in two large-scale multinational, randomized, double-blind, placebo-controlled Phase III clinical trials.

The Phase III Thrombin Receptor Antagonist in Secondary Prevention of Atherothrombotic Ischemic Events (TRA 2P-TIMI 50) trial is a multinational, randomized, double-blind, placebo-controlled study in approximately 19,500 patients with prior MI or stroke, as well as patients with existing peripheral arterial disease. Patients will be randomized to either placebo plus standard medical care (including aspirin and clopidogrel) or to TRA once daily plus standard medical care. This Phase III trial uses the 2.5 mg maintenance dose. The primary endpoint of the trial is the composite of cardiovascular death, MI, urgent coronary revascularization or stroke. The key secondary endpoint is the composite of cardiovascular death, MI or stroke. Patients will be followed for a minimum of one year. This Phase III trial is being conducted by the Thrombolysis in Myocardial Infarction (TIMI) Study Group.

The Phase III Thrombin Receptor Antagonist Clinical Event Reduction in acute coronary syndrome (TRA-CER) trial is a multinational, randomized, double-blind, placebo-controlled study in approximately 10,000 patients with non-ST-seg
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SOURCE Schering-Plough Corporation
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