Apixaban Validation Study - Additional Study on Fresh Samples

Completed

• Conditions: Anticoagulation With Apixaban
• Interventions: Device: STA-Apixaban Calibrator & Control

• Registration Number: NCT03073265
• Lead Sponsor: Diagnostica Stago

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.

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 Timeline

• Study First Submitted: 2017-02-27
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-08
• Status Verified: 2017-05
• Study Start: 2017-05-08
• Primary Completion: 2017-11-01
• Study Completion: 2017-11-01
• Last Update Submitted: 2018-03-08
• Last Update Posted: 2018-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients on apixaban	STA-Apixaban Calibrator & Control	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.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Lehigh Valley Health Nrwork; 🇺🇸 Allentown, Pennsylvania, United States

Moses Cone Memorial Hospital; 🇺🇸 Greensboro, North Carolina, United States