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SCH 530348 (TRA), a Novel Investigational Antiplatelet Agent, Shown to Inhibit Platelet Aggregation in PCI Patients
Date:11/7/2007

cular 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-segment elevation acute coronary syndrome. Patients will be randomized to either placebo plus standard medical care (including aspirin or clopidogrel) or to TRA plus standard medical care. The Phase III TRA-CER trial will use the oral 40 mg loading dose and the 2.5 mg maintenance dose. In the Phase II TRA-PCI trial, this dose was not statistically different from placebo in the combination of TIMI Major and Minor bleeding, and although not statistically significant, resulted in the greatest reduction in major adverse cardiac events, predominately periprocedural myocardial infarctions.

The primary endpoint of the Phase III TRA-CER trial is the composite of cardiovascular death, MI, rehospitalization for ACS, 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 Duke Clinical Research Institute, Durham, NC.

These Phase III trials follow the results of two Japanese Phase II trials in ACS patients and in patients with previous ischemic events that further documented the lack of incremental bleeding with the use of TRA plus standard of care, and, for the first time, reported a statistically significant reduction in cardiovascular events, specifically periprocedural myocardial infarction (MI) in the ACS patients undergoing PCI.

About the Thrombin Receptor Antagonist

The investigational antiplatelet TRA is being developed by Schering-Plough for the prevention and treatm
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SOURCE Schering-Plough Corporation
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