Validation of Rivaroxaban Assay for US Registration

Sponsor

Diagnostica Stago (Industry)

Overall Status

Completed

CT.gov ID

NCT02333929

Collaborator

(none)

100

Enrollment

Location

21.1

Actual Duration (Months)

4.7

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Patients Receiving Rivaroxaban Treatment	Device: STA- Rivaroxaban Calibrator&Control

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.

Study Design

Study Type:

Observational

Actual Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Validation of Rivaroxaban Assay for US Registration

Actual Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Dec 1, 2016

Actual Study Completion Date :

Dec 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
VTE prevention Prophylaxis of VTE in patients undergoing knee or hip replacement surgery (10 mg OD): orthopaedic department of the hospital will be in charge of the sample collection.	Device: STA- Rivaroxaban Calibrator&Control One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)
DVT/PE treatment Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and risk reduction of DVT and PE recurrence; (15 mg BID for 3 weeks then 20 mg OD): different departments of the hospital will be in charge of the sample collection (samples can come e.g., from emergency room, vascular lab or cancer unit).	Device: STA- Rivaroxaban Calibrator&Control One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)
SPAF Stroke prevention and reduction of systemic embolism in non-valvular patients with atrial fibrillation (SPAF) (20 mg OD): cardiology department of the hospital will be in charge of the sample collection.	Device: STA- Rivaroxaban Calibrator&Control One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

Arm

Intervention/Treatment

VTE prevention

Prophylaxis of VTE in patients undergoing knee or hip replacement surgery (10 mg OD): orthopaedic department of the hospital will be in charge of the sample collection.

Device: STA- Rivaroxaban Calibrator&Control

One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

DVT/PE treatment

Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and risk reduction of DVT and PE recurrence; (15 mg BID for 3 weeks then 20 mg OD): different departments of the hospital will be in charge of the sample collection (samples can come e.g., from emergency room, vascular lab or cancer unit).

Device: STA- Rivaroxaban Calibrator&Control

One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

SPAF

Stroke prevention and reduction of systemic embolism in non-valvular patients with atrial fibrillation (SPAF) (20 mg OD): cardiology department of the hospital will be in charge of the sample collection.

Device: STA- Rivaroxaban Calibrator&Control

One sample blood collected per patient the day of the treatment (drawn soon after the the drug intake)

Outcome Measures

Primary Outcome Measures

Number of participants tested once during their rivaroxaban treatment [1 day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Between 30 and 40 samples/site obtained from patients treated with rivaroxaban.(ideally 10-15 samples per indication and per site depending on the site practices):

Prophylaxis of VTE in patients undergoing knee or hip replacement surgery (10 mg OD): orthopaedic department of the hospital will be in charge of the sample collection.
Treatment of deep vein thrombosis (DVT), pulmonary embolism (PE), and risk reduction of DVT and PE recurrence; (15 mg BID for 3 weeks then 20 mg OD): different departments of the hospital will be in charge of the sample collection (samples can come e.g., from emergency room, vascular lab or cancer unit).
Stroke prevention and reduction of systemic embolism in non-valvular patients with atrial fibrillation (SPAF) (20 mg OD): cardiology department of the hospital will be in charge of the sample collection.

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 in CLSI H21-A5