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Apixaban Validation Study - Additional Study on Fresh Samples

Sponsor
Diagnostica Stago (Industry)
Overall Status
Completed
CT.gov ID
NCT03073265
Collaborator
(none)
109
Enrollment
2
Locations
5.8
Actual Duration (Months)
54.5
Patients Per Site
9.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: STA-Apixaban Calibrator & Control

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 Design

Study Type:
Observational
Actual Enrollment :
109 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
Actual Study Start Date :
May 8, 2017
Actual Primary Completion Date :
Nov 1, 2017
Actual Study Completion Date :
Nov 1, 2017

Arms and Interventions

Arm 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).

Outcome Measures

Primary Outcome Measures

  1. 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Moses Cone Memorial Hospital Greensboro North Carolina United States 27401
2 Lehigh Valley Health Nrwork Allentown Pennsylvania United States 18101

Sponsors and Collaborators

  • Diagnostica Stago

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Diagnostica Stago
ClinicalTrials.gov Identifier:
NCT03073265
Other Study ID Numbers:
  • VSP A006 - US_comp / 1
First Posted:
Mar 8, 2017
Last Update Posted:
Mar 9, 2018
Last Verified:
May 1, 2017
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
Keywords provided by Diagnostica Stago
DOAC
apixaban
IVD
Additional relevant MeSH terms:
Apixaban

Study Results

No Results Posted as of Mar 9, 2018