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

romising therapeutic option for patients with unstable angina and non-ST elevation MI undergoing PCI ," said Rick Veltri, M.D., Group Vice President of Global Clinical Research, Cardiovascular and Metabolic Disease, Schering- Plough Research Institute. "With our global Phase III clinical development program underway, we are continuing to evaluate the potential for TRA as a novel agent in reducing the incidence of cardiovascular events with no incremental bleeding when added to standard of care in the treatment of patients with acute coronary syndromes or established vascular disease," added Veltri.

The results were presented today at the American Heart Association Scientific Sessions in Orlando, FL, in a session titled "Thrombin Receptor Antagonist Is a Selective, Potent Inhibitor of PAR-1 Activity With Predictable Pharmacokinetics."

About TRA-PCI

The Phase II TRA-PCI Trial was a multinational, randomized, double-blind, placebo-controlled dose-ranging trial assessing oral loading doses and maintenance doses of TRA. The trial enrolled 1,030 patients randomized to one of three oral loading doses of TRA (10 mg, 20 mg, 40 mg) plus standard of care (clopidogrel + aspirin) or placebo plus standard of care in a 3:1 ratio of active drug to placebo. Patients who received a TRA-loading dose and subsequently underwent PCI (n=573) were randomized to one of three oral daily maintenance doses of TRA (0.5 mg, 1.0 mg, 2.5 mg). Patients who received placebo were randomized to receive standard of care alone. The total duration of treatment was 60 days. Patients were followed for an additional 60 days post-treatment.

A secondary endpoint in a sub-study within the primary evaluable patient cohort was inhibition of platelet aggregation (IPA) induced by appropriate agonists relative to baseline.

TRA-PCI results were first presented at a late-breaking clinical trial session at the March 2007 Scientific Sessions of the American College of Cardiology/i2 Summit
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SOURCE Schering-Plough Corporation
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