The Thrombin Receptor Antagonist for Clinical Event Reduction in Acute Coronary Syndrome (TRA*CER) trial: study...

Area of Science:

• Cardiovascular Medicine
• Pharmacology
• Clinical Trials

Background:

• Protease-activated receptor 1 (PAR-1) is a key platelet receptor for thrombin and a novel target for arterial thrombosis treatment.
• SCH 530348 is an orally active, selective, competitive PAR-1 antagonist.
• Non-ST-segment elevation acute coronary syndromes (NSTE ACS) with high-risk features require effective therapeutic strategies.

Purpose of the Study:

• To evaluate the efficacy and safety of SCH 530348 compared with placebo in patients with NSTE ACS and high-risk features.
• To demonstrate SCH 530348's ability to reduce the incidence of major adverse cardiovascular events when added to standard care.
• To assess the safety profile of SCH 530348, including bleeding events.

Main Methods:

• TRA*CER is a prospective, randomized, double-blind, multicenter, phase III trial.
• The study includes approximately 10,000 subjects.
• Primary endpoint: composite of cardiovascular death, myocardial infarction (MI), stroke, recurrent ischemia with rehospitalization, and urgent coronary revascularization. Key secondary endpoint: composite of cardiovascular death, MI, or stroke. Safety endpoints include bleeding events.

Main Results:

• Results are pending completion of the trial, which requires a predetermined number of adjudicated primary and key secondary endpoint events.
• The trial is designed to provide definitive data on the efficacy and safety of SCH 530348 in the target population.
• The study will continue until all subjects have at least 1 year of follow-up.

Conclusions:

• The TRA*CER trial is expected to define the efficacy and safety of the novel PAR-1 inhibitor SCH 530348.
• Findings will inform treatment strategies for high-risk NSTE ACS patients.
• This study is part of a larger phase III development program for SCH 530348.