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Apixaban Validation Study - Additional Study on Fresh Samples

NCT03073265 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 109

Last updated 2018-03-09

No results posted yet for this study

Summary

The objective is to demonstrate the performances of STA® - Apixaban Calibrator \& STA® - Apixaban Control used in combination with STA® - Liquid Anti-Xa to measure apixaban concentration in plasma. Anti-Xa results will be compared to LCMS (liquid chromatography - mass spectrometry) for validation of the assay. For this study, the anti-Xa assay will be performed on fresh samples only.

The results will be used to complete results obtained previously on frozen samples.

Conditions

  • Anticoagulation With Apixaban

Interventions

DEVICE

STA-Apixaban Calibrator & Control

Measurement of apixaban level will be done using anti-Xa assay (IVD).

Sponsors & Collaborators

  • Diagnostica Stago

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-08
Primary Completion
2017-11-01
Completion
2017-11-01
FDA Device
Yes

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 NCT03073265 on ClinicalTrials.gov