Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels

Atrial Fibrillation Clinical Trial

— UniXa  

Official title:

Multicentric Prospective Validation of a Universal Test to Quantify Apixaban, Rivaroxaban, Danaparoid and Fondaparinux Levels

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04539301
• Other study ID #: RC20_0061
• Status: Recruiting
• Start date: April 1, 2021
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: Nantes University Hospital
• Contact: Elodie BOISSIER
• Phone: 330240165465
• Email: elodie.boissier[@]chu-nantes.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Despite their usefulness in perioperative and acute care settings, factor-Xa inhibitors-specific assays are scarcely available, contrary to heparin anti-Xa assay. The investigators aimed at assessing whether the widely used heparin anti-Xa assay can quantify the apixaban, rivaroxaban, fondaparinux and danaparoid levels.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2100
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria :

• Blood sample from adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux

Exclusion Criteria :

• Patients treated with unfractionated heparin or low molecular weight heparin

Related Conditions & MeSH terms

• Anticoagulation
• Atrial Fibrillation
• Thromboembolism
• Venous Thromboembolism

Intervention

Diagnostic Test:
• Estimated anticoagulant level (conversion factor x anti-Xa activity)
Estimated anticoagulant level (conversion factor x anti-Xa activity)

Locations

Country	Name	City	State
France	Nantes University Hospital	Nantes	Loire-Atlantique

Sponsors (1)

Lead Sponsor	Collaborator
Nantes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Agreement between measured and estimated levels of each factor-Xa inhibitor	An estimated anticoagulant level between 80 and 120% of the value obtained by the reference method ("specific assay") will be deemed clinically acceptable, i.e. the patient's management would have been the same.	2 years
Secondary	Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program		2 years
Secondary	Cost comparison (estimated anticoagulant level method versus specific dosage)		2 years