Apixaban Validation Study - Additional Study on Fresh Samples

March 8, 2018 updated by: Diagnostica Stago

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

109

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Greensboro, North Carolina, United States, 27401
        • Moses Cone Memorial Hospital
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18101
        • Lehigh Valley Health Nrwork

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients treated with apixaban presenting at least one of the listed inclusion criteria.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Device: STA-Apixaban Calibrator & Control
Measurement of apixaban level will be done using anti-Xa assay (IVD).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diagnostica Stago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 8, 2017

Primary Completion (ACTUAL)

November 1, 2017

Study Completion (ACTUAL)

November 1, 2017

Study Registration Dates

First Submitted

February 27, 2017

First Submitted That Met QC Criteria

March 2, 2017

First Posted (ACTUAL)

March 8, 2017

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

May 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSP A006 - US_comp / 1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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