Apixaban Validation Study - Additional Study on Fresh Samples

Completed

Conditions studied: Anticoagulation With Apixaban

In brief

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.

Key facts

Study ID

NCT03073265

Run by

Diagnostica Stago

People needed

109

Starts

2017-05-08

Expected to finish

2017-11-01

Last updated by the study team

2018-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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