Trials / Completed
CompletedNCT03073265
Apixaban Validation Study - Additional Study on Fresh Samples
Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 109 (actual)
- Sponsor
- Diagnostica Stago · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
About 60 samples from patients on apixaban meeting inclusion/exclusion criteria will be included in this study. Two sites will be in charge of sample recruitment and anti-Xa testing. A third site will be in charge of LCMS testing.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | STA-Apixaban Calibrator & Control | Measurement of apixaban level will be done using anti-Xa assay (IVD). |
Timeline
- Start date
- 2017-05-08
- Primary completion
- 2017-11-01
- Completion
- 2017-11-01
- First posted
- 2017-03-08
- Last updated
- 2018-03-09
Locations
2 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03073265. Inclusion in this directory is not an endorsement.