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Validation of Rivaroxaban Assay for US Registration

NCT02333929 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2017-02-14

No results posted yet for this study

Summary

The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa activity.

Conditions

  • Patients Receiving Rivaroxaban Treatment

Interventions

DEVICE

STA- Rivaroxaban Calibrator&Control

One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

Sponsors & Collaborators

  • Diagnostica Stago

    lead INDUSTRY

Principal Investigators

  • James Groce, Pharm D. · Cone Health

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02333929 on ClinicalTrials.gov