NCT02333929

Validation of Rivaroxaban Assay for US Registration

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 100 (actual)
• Sponsor: Diagnostica Stago · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The objective of the study is to demonstrate the performances of the STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control in combination with the STA® - Liquid Anti-Xa to determine the quantity of rivaroxaban in plasma samples by measurement of its direct anti-Xa activity.

Detailed description

The study is a method comparison between a reference method (LCMS) and the candidate device. Between 90 and 120 samples obtained from patients treated by rivaroxaban will be collected on 3 sites in the US according to the inclusion and exclusion criteria detailed in the protocol. These samples will be frozen after the collection and sent to the hemostasis laboratories for testing and to a LCMS central laboratory validated for rivaroxaban measurement. Results expressed in ng/mL obtained with STA® - Liquid Anti-Xa, used in combination with STA® - Rivaroxaban Calibrator and STA® - Rivaroxaban Control will be compared to the result obtained by the LCMS laboratory. Diagnostica Stago will analyse the results thanks to regressions according to CLSI EP9-A3 recommendations (guideline dedicated to method comparison for quantitative assay) in order to support the equivalence between the 2 methods.

Conditions

• Patients Receiving Rivaroxaban Treatment

Interventions

Type	Name	Description
DEVICE	STA- Rivaroxaban Calibrator&Control	One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-01-07
• Last updated: 2017-02-14

Locations

1 site across 1 country: United States