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

exposed to a very potent stimulant (TRAP-thrombin receptor agonist peptide)," said Enrico Veltri, M.D., group vice president of global clinical research, cardiovascular and metabolic disease, Schering-Plough Research Institute. "These data, along with subsequent data from Phase II acute coronary syndromes (ACS) and stroke studies conducted in Japan, suggest that TRA is a novel medication that targets a pathway to platelet aggregation not addressed by existing medications."

The 1,030-patient TRA-PCI trial was designed to evaluate the safety and tolerability of TRA in patients undergoing PCI. A secondary objective was to assess whether patients treated with the compound in addition to standard-of-care therapies had fewer cardiovascular events such as heart attack, need for urgent coronary revascularization, or death at 60 days compared to patients treated with the standard of care alone. While not powered to establish efficacy, the study did report a non-statistically significant 46 percent reduction in cardiovascular events at the highest TRA dose tested compared to standard of care alone. Preliminary results were presented in March 2007 at the American College of Cardiology/i2 Summit in New Orleans by David J. Moliterno, M.D., Chief of Cardiovascular Medicine, University of Kentucky College of Medicine, and Medical Director of the Linda and Jack Gill Heart Institute, on behalf of the TRA-PCI investigators.

Study Design

The Phase II TRA-PCI trial was a multinational, randomized, double-blind, placebo-controlled dose-ranging trial assessing both oral loading doses as well as maintenance doses of Schering-Plough's TRA. The trial enrolled 1,030 patients 45 years or older, with coronary artery disease for whom PCI was planned, and randomized to one of three oral loading doses of TRA (10mg, 20mg or 40mg) or placebo in a 3:1 ratio of active drug to placebo. The loading doses were increased in a sequential fas
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SOURCE Schering-Plough Corporation
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