Apixaban Validation Study - Additional Study on Fresh Samples

NCT03073265 | Completed FDA Device

• 1 other identifier: VSP A006 - US_comp / 1
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Anticoagulation With Apixaban

Keywords

DOAC; apixaban; IVD

Outcome Measures

Primary Outcomes (1)

• Method comparison between Anti-Xa method and LCMS to measure apixaban in plasma

  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.

  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.

Study Arms (1)

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

Interventions

STA-Apixaban Calibrator & Control DEVICE

Measurement of apixaban level will be done using anti-Xa assay (IVD).

Patients on apixaban

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients treated with apixaban presenting at least one of the listed inclusion criteria.

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.

Sponsors & Collaborators

• Diagnostica Stago: lead

Study Sites (2)

Moses Cone Memorial Hospital

Greensboro, North Carolina, 27401, United States

Location

Lehigh Valley Health Nrwork

Allentown, Pennsylvania, 18101, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2017
• First Posted: March 8, 2017
• Study Start: May 8, 2017
• Primary Completion: November 1, 2017
• Study Completion: November 1, 2017
• Last Updated: March 9, 2018

Record last verified: 2017-05

Locations

US (2)