Apixaban Validation Study - Additional Study on Fresh Samples

Study Overview
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Brief Summary
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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
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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.

Official Title
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Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control

Conditions
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Anticoagulation With Apixaban

Intervention / Treatment
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* Device: STA-Apixaban Calibrator & Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 75 years, Weight ≤ 60 kg, Haematocrit below normal values as determined by local laboratory or < 40% for male and < 37% for female Renal impairment documented (creatinine clearance ≤ 80 mL/min as per Cockcroft -Gault equation) or serum creatinine ≥ 1.5 mg/dL Co-medication with aspirin or any other NSAIDs (nonsteroidal anti-inflammatory drugs) Co-medication with anti-platelet agents Exclusion Criteria: Patients less than 18 years old Patients under other anti-coagulant treatment Samples that are not collected, stored, or handled in accordance with sample collection procedures defined above.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients on apixaban<br>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. | Device: STA-Apixaban Calibrator & Control<br>* Measurement of apixaban level will be done using anti-Xa assay (IVD).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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DOAC, apixaban, IVD