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Clinical Trial Summary

Currently, there are no data available regarding the effect of vorapaxar on clot generation kinetics or TIP-FCS when added to standard of care antiplatelet regimens. Potential reduction of TIP-FCS and clot generation kinetics by vorapaxar may assist in our understanding of the mechanism of action and in personalizing therapy in high risk patients to effectively reduce recurrent thrombotic event occurrences. The objective of this study is to determine onset-, maintenance-, and offset-effect of vorapaxar on platelet-fibrin clot generation kinetics by thrombelastography (R, TIP-FCS, TG) and thrombin generation kinetics (Lag time, peak thrombin production, time to peak thrombin generation, and endogenous thrombin potential) in antiplatelet naïve patients and patients on mono and dual antiplatelet therapy. This is a phase IV, prospective cohort (4 groups), non-randomized, open label, pharmacodynamics, and safety investigation.


Clinical Trial Description

n/a


Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


NCT number NCT02629367
Study type Interventional
Source Inova Health Care Services
Contact Kevin Bliden, MS, MBA
Phone 7037767702
Email Kevin.Bliden@inova.org
Status Not yet recruiting
Phase Phase 4
Start date January 2016
Completion date March 2017

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