NCT02333929

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 5, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 7, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

February 14, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

January 5, 2015

Last Update Submit

February 13, 2017

Conditions

Patients Receiving Rivaroxaban Treatment

Keywords

rivaroxabanNOACanti-Xa activitymethod comparisonLCMS

Outcome Measures

Primary Outcomes (1)

  • Number of participants tested once during their rivaroxaban treatment

    1 day

Study Arms (3)

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

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

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

Interventions

STA- Rivaroxaban Calibrator&ControlDEVICE

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

DVT/PE treatmentSPAFVTE prevention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lehigh Valley Health Nrwork

Allentown, Pennsylvania, 18101, United States

Location

Related Publications (2)

  • Baglin T, Hillarp A, Tripodi A, Elalamy I, Buller H, Ageno W. Measuring Oral Direct Inhibitors (ODIs) of thrombin and factor Xa: A recommendation from the Subcommittee on Control of Anticoagulation of the Scientific and Standardisation Committee of the International Society on Thrombosis and Haemostasis. J Thromb Haemost. 2013 Jan 24. doi: 10.1111/jth.12149. Online ahead of print.

    PMID: 23347120BACKGROUND

  • Favaloro EJ, Lippi G. The new oral anticoagulants and the future of haemostasis laboratory testing. Biochem Med (Zagreb). 2012;22(3):329-41. doi: 10.11613/bm.2012.035.

    PMID: 23092064BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples

Study Officials

  • James Groce, Pharm D.

    Cone Health

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

January 5, 2015

First Posted

January 7, 2015

Study Start

March 1, 2015

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

February 14, 2017

Record last verified: 2017-02

Locations

US(1)