Apixaban Validation Study - Additional Study on Fresh Samples

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03073265

Enrollment

109

Registered

2017-03-08

Start date

2017-05-08

Completion date

2017-11-01

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anticoagulation With Apixaban

Keywords

DOAC, apixaban, IVD

Brief 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.

Interventions

DEVICESTA-Apixaban Calibrator & Control

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma	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.	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026