Merck announces changes to Phase 3 studies of vorapaxar for prevention of cardiac events

Following an announcement from the two academic centers leading the two Phase 3 studies of vorapaxar, Merck announced changes to both trials, known as the TRACER and TRA-2P studies. Merck is studying vorapaxar in two major clinical endpoint trials to evaluate the investigational medicine for the prevention of cardiac events: TRACER, a study of approximately 13,000 patients with acute coronary syndrome, and TRA-2P (also known as TIMI 50), a study of approximately 26,500 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. The study chairpersons agreed to implement the following changes:

  • In the TRACER study, patients will discontinue 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.

Vorapaxar (also known as SCH 530348) is a selective PAR-1 (Protease Activated Receptor 1) Thrombin Receptor Antagonist designed to diminish thrombosis (clot formation).

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