Validation of Rivaroxaban Assay for US Registration

February 13, 2017 updated by: Diagnostica Stago
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Allentown, Pennsylvania, United States, 18101
        • Lehigh Valley Health Nrwork

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients receiving rivaroxaban treatment for one of the 3 drug indications cleared in the US

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants tested once during their rivaroxaban treatment
Time Frame: 1 day
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Diagnostica Stago

Investigators

  • Principal Investigator: James Groce, Pharm D., Cone Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2015

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

December 1, 2016

Study Registration Dates

First Submitted

January 5, 2015

First Submitted That Met QC Criteria

January 6, 2015

First Posted (Estimate)

January 7, 2015

Study Record Updates

Last Update Posted (Actual)

February 14, 2017

Last Update Submitted That Met QC Criteria

February 13, 2017

Last Verified

February 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VSP P391-US

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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