Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients on apixaban | Patients currently on apixaban who meet inclusion/exclusion criteria A blood draw will be done on each patient to measure apixaban concentration in plasma using anti-Xa assay and LCMS. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| STA-Apixaban Calibrator & Control | Device | Measurement of apixaban level will be done using anti-Xa assay (IVD). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma | Compare results from anti-Xa assay and LCMS to measure apixaban in plasma samples. Regression and difference charts will be used to compare the methods. | The anti-Xa assay will be tested within 6h after sample collection and LCMS will be performed on frozen samples, at maximum 2 months after collection. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Patients treated with apixaban presenting at least one of the listed inclusion criteria.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moses Cone Memorial Hospital | Greensboro | North Carolina | 27401 | United States | ||
| Lehigh Valley Health Nrwork |
Not provided
Not provided
Not provided
Not provided
Plasma samples
| Allentown |
| Pennsylvania |
| 18101 |
| United States |