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

NCT04539301 | Recruiting

• 1 other identifier: RC20_0061
• Study Type: observational
• Target: 2,100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Anticoagulation; Venous Thromboembolism; Atrial Fibrillation

Keywords

Anticoagulants (MeSH); Blood Coagulation Tests (MeSH); Drug monitoring (MeSH); Factor Xa Inhibitors (MeSH); Heparin (MeSH)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Evaluation of the performance of the estimated anticoagulant level method by an inter-laboratory comparison program

  2 years

• Cost comparison (estimated anticoagulant level method versus specific dosage)

  2 years

Study Arms (2)

Derivation cohort

In the derivation cohort, we will determined the conversion factor linking apixaban, rivaroxaban, fondaparinux, or danaparoid measured level, on the one hand, and heparin anti-Xa activity, on the other hand.

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

Validation cohort

In the validation cohort, for each tested anticoagulant, we will used the conversion factor determined in the derivation cohort to infer the estimated level of anticoagulant from heparin anti-Xa activity: estimated anticoagulant level = conversion factor for this anticoagulant × heparin anti-Xa activity The agreement between measured and estimated levels of each factor-Xa inhibitor will be assessed.

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

Interventions

Estimated anticoagulant level (conversion factor x anti-Xa activity) DIAGNOSTIC_TEST

Estimated anticoagulant level (conversion factor x anti-Xa activity)

Derivation cohort; Validation cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients treated with apixaban or rivaroxaban or danaparoid or fondaparinux

You may qualify if:

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

You may not qualify if:

• Patients treated with unfractionated heparin or low molecular weight heparin

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (1)

Nantes University Hospital

Nantes, Loire-Atlantique, 44093, France

RECRUITING

MeSH Terms

Conditions

Venous Thromboembolism; Atrial Fibrillation

Condition Hierarchy (Ancestors)

Thromboembolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Elodie BOISSIER

CONTACT

330240165465; elodie.boissier@chu-nantes.fr

Annick COULON

CONTACT

330253482835; bp-prom-regl@chu-nantes.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2020
• First Posted: September 4, 2020
• Study Start: April 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)