Friday, January 14, 2011

Changes to Clinical Studies of Vorapaxar

Yesterday, Merck announced changes to the clinical studies for vorapaxar. Vorapaxar is a selective PAR-1 (Protease Activated Receptor) Thrombin Receptor Antagonist designed to diminish thrombosis (clot formation).

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 have agreed to implement these changes, and communicated the following information to study investigators:

* 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 percent 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.

You can read more about their changes here on the Merck website.

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