Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
1 other identifier
interventional
150
0 countries
N/A
Brief Summary
Direct oral anticoagulants (DOAC), an inhibitor of factor IIa (dabigatran) or factor Xa inhibitors (rivaroxaban, apixaban) are an alternative to treatment with warfarin in patients with atrial fibrillation (AF) non-valvular . These molecules have demonstrated non-inferiority compared to warfarin standard treatment for the prevention of thromboembolic events in patients with non-valvular AF at high risk thomboembolique (Score CHA2DS2-VASc ≥1). These molecules have a constant biological effectiveness does not require laboratory monitoring in clinical practice, unlike AVK whose use requires, because of their variability action intra- and inter-individual, a constant dose adjustment based on 'Nationalized Index Ratio (INR). The objective of this study is to evaluate the interest of specific dosage of anti-activated factor X activity (Xa) in the identification of non-observing treating patients with Factor Xa inhibitor in patients with non-FA valvular
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable atrial-fibrillation
Started Nov 2016
Longer than P75 for not_applicable atrial-fibrillation
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 4, 2016
CompletedFirst Posted
Study publicly available on registry
October 5, 2016
CompletedStudy Start
First participant enrolled
November 27, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 19, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
November 18, 2022
CompletedApril 7, 2023
April 1, 2023
2 years
October 4, 2016
April 6, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Anti factor Xa activity dosage
Rivaroxaban and apixaban concentrations will be determined using the Biophen Heparin LRT anti-Xa assay (Hyphen BioMed, Neuville-sur-Oise, France). This assay is a chromogenic assay for in vitro quantitative measurement of indirect or direct Factor Xa inhibitors. All analyses will be performed on the STA-R Evolution Analyzer (Stago, Asnières sur Seine, France).
one day
Study Arms (1)
patient with atrial fibrillation
OTHERInterventions
The adherence will be evaluated by biological results
Eligibility Criteria
You may qualify if:
- Atrial fibrillation patients aged ≥ 18 years.
- Treated with rivaroxaban 20 mg or 15 mg once daily or apixaban 5 mg or 2.5 mg twice daily for at least 4 weeks.
- Able to provide informed consent.
You may not qualify if:
- Valvular atrial fibrillation (i.e. mitral stenosis, valvular prosthesis).
- Pregnancy or breast feeding
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Urielle DESALBRES
Assistance Publique Hôpitaux de Marseille
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 4, 2016
First Posted
October 5, 2016
Study Start
November 27, 2016
Primary Completion
November 19, 2018
Study Completion
November 18, 2022
Last Updated
April 7, 2023
Record last verified: 2023-04