The study examined the thrombin receptor antagonist (TRA), SCH 530348, in combination with standard antiplatelet therapy (including aspirin and clopidogrel) among patients undergoing percutaneous coronary intervention
(PCI).
The trial was designed to evaluate the safety and tolerability of TRA in patients undergoing PCI. A secondary objective was to assess whether patients 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.
Although the study was not designed to establish efficacy, the study did report a 46% reduction in cardiovascular events at the highest TRA dose tested compared to standard of care.
“While further study is required, the 46% reduction in cardiovascular events represents an early signal of the activity for this novel antiplatelet compound. This is encouraging, particularly in light of the fact that this patient population requires advanced therapies and is difficult to treat,” said David Moliterno, chief of Cardiovascular Medicine, University of Kentucky College of Medicine.
The FDA had previously granted fast track designation to the compound which allows for an expedite review of the drug.