Apixaban Validation Study – Additional Study on Fresh Samples

Overview

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.

Full Title of Study: “Validation Study Protocol – Additional Study on Fresh Samples STA – Apixaban Calibrator & STA – Apixaban Control”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: November 1, 2017

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

  • Device: STA-Apixaban Calibrator & Control
    • Measurement of apixaban level will be done using anti-Xa assay (IVD).

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma
    • Time Frame: 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Diagnostica Stago
  • Provider of Information About this Clinical Study
    • Sponsor

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