Validation of Rivaroxaban Assay for US Registration

Completed

Conditions studied: Patients Receiving Rivaroxaban Treatment

In brief

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.

Key facts

Study ID: NCT02333929
Run by: Diagnostica Stago
People needed: 100
Starts: 2015-03-01
Expected to finish: 2016-12-01
Last updated by the study team: 2017-02-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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.

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 in CLSI H21-A5

Where it is running

Lehigh Valley Health Nrwork — Allentown, Pennsylvania, United States

Full record on ClinicalTrials.gov

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