Apixaban Validation Study - Additional Study on Fresh Samples

Diagnostica Stago

Status: Completed

Conditions: Anticoagulation With Apixaban

Treatments: Device: STA-Apixaban Calibrator & Control

Study type: Observational

Funder types: Industry

Identifiers

NCT03073265

VSP A006 - US_comp / 1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 109 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

109 participants in 1 patient group

Patients on apixaban

Description:

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.

Treatment:

Device: STA-Apixaban Calibrator & Control