Vorapaxar in the Human Endotoxemia Model

Summary

Vorapaxar is a recently approved protease activated receptor - 1 (PAR-1) inhibitor. Platelet inhibition may also exert positive results on coagulation activation and may beneficially influence the inflammatory response. Since vorapaxar is the first available substance of a new class of platelet inhibitors its effects on the human coagulation system and the inflammatory response will be assessed in the well-established human endotoxemia model.

Timeline

Start

2016-06

Primary completion

2016-11-30

Completion

2016-11-30

Outcome

Met primary endpoint

registry MEDIAN Vorapaxar: 1315 (835 to 1800) pmol/L NCT02875028 ↗

registry analysis (superiority test); Vorapaxar vs Placebo; p = 0.029; Wilcoxon (Mann-Whitney) NCT02875028 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Vorapaxar	Small molecule	10 mg	—

Indications

No indication recorded.