Tracer trial is evaluating patients with acute coronary syndrome; however, TRA-2P (also known as TIMI 50) is assessing patients with prior heart attack, stroke and peripheral artery disease.
The combined Data and Safety Monitoring Board for the two studies has reviewed the available safety and efficacy data, and made recommendations for study changes to the chairpersons.
According to the recommendations, Merck will discontinue Tracer study, drug and investigators are to begin now to close out the study in a timely and orderly fashion.
In the TRA-2P study, study drug will be continued in patients who had experienced a previous heart attack or peripheral arterial disease (approximately 75% of the patients enrolled in the study), and will be immediately discontinued in patients who experienced a stroke prior to entry into the study or during the course of the study.
Merck plans to update its projections for regulatory filings for Vorapaxar once the company has received the efficacy and safety data from Tracer and can determine an updated completion date for TRA-2P.