TRA-2P: Vorapaxar met primary CV endpoint, increased bleeding risk

Issue: May 2012

Merck has announced results of the TRA-2P study, which compared the investigational oral protease-activated receptor-1 antagonist vorapaxar added to standard of care with standard of care alone in patients with MI, ischemic stroke or documented peripheral vascular disease.

The trial met the protocol-specified primary endpoint of the composite of CV death, MI, stroke or urgent coronary revascularization with vorapaxar vs. standard of care alone. However, vorapaxar was associated with significant bleeding, including intracranial hemorrhage, although researchers noted a lower risk in patients without a history of stroke, according to a press release issued by Merck.

Full data from the TRA-2P study will be presented in March at the American College of Cardiology Scientific Sessions.

“We are pleased that TRA-2P met its primary endpoint and we look forward to discussing the results with the scientific community,” Peter S. Kim, president of Merck Research Laboratories, said in the press release.

Vorapaxar has been evaluated in two major clinical outcome studies: TRA-2P and TRACER. TRA-2P TIMI 50 was led by the TIMI Study Group of Brigham and Women’s Hospital. The secondary prevention TRA-2P study was conducted in 26,449 patients. TRACER was an acute care, hospital-based study of 12,944 patients with non-ST segment elevation acute coronary syndrome. Results of TRACER, which were presented at the 2011 American Heart Association Scientific Sessions and simultaneously published in The New England Journal of Medicine, showed that vorapaxar was associated with a nonsignificant reduction in the first occurrence of the composite primary outcome and was associated with an approximately 40% greater risk for bleeding and a threefold increase in intracranial hemorrhage vs. standard care alone.

The drug is being investigated by Merck for the prevention of thrombosis and the reduction of CV events.

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