STA-Apixaban Calibrator & Control
DeviceMeasurement of apixaban level will be done using anti-Xa assay (IVD).
Completed
NCT Number: NCT03073265
Apixaban Validation Study - Additional Study on Fresh Samples
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.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Moses Cone Memorial Hospital, Greensboro, North Carolina, United States
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About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
Primary outcomes
-
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.
Sponsors and collaborators
Lead sponsor
Diagnostica Stago
Industry
Registry information
Official study title
Validation Study Protocol - Additional Study on Fresh Samples STA - Apixaban Calibrator & STA - Apixaban Control
Important dates
- Study start
- 2017
- Primary completion
- 2017
- Study completion
- 2017
- First posted
- Mar 8, 2017
- Registry last updated
- Mar 9, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.