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NCT04539301 Clinical Trial

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
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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