Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
Primary Purpose
Atrial Fibrillation
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Adherence to oral anticoagulant treatment
Sponsored by
About this trial
This is an interventional other trial for Atrial Fibrillation
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
- Valvular atrial fibrillation (i.e. mitral stenosis, valvular prosthesis).
- Pregnancy or breast feeding
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
patient with atrial fibrillation
Arm Description
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Full Information
NCT ID
NCT02925247
First Posted
October 4, 2016
Last Updated
April 6, 2023
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02925247
Brief Title
Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
Official Title
Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
November 27, 2016 (Actual)
Primary Completion Date
November 19, 2018 (Actual)
Study Completion Date
November 18, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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
Detailed Description
Direct oral anticoagulants (DOAC), either factor IIa inhibitor (dabigatran) or factor Xa inhibitors (rivaroxaban, apixaban) are an alternative to vitamin K antagonist in patients with non-valvular atrial fibrillation (AF) . These drugs have demonstrated their non-inferiority, compared to warfarin, for the prevention of thromboembolic events in high risk (CHA2DS2-VASc ≥1) non-valvular AF patients . These medications have predictable pharmacological effects and limited drugs and foods interactions which relieve from the need of routine anticoagulation monitoring compared to warfarin.
One of the limitations of these drugs is their short half-lives (about 12 hours for all three drugs) . Thus, a single missed dose of DOACs regimen may result in suboptimal anticoagulation. Adequate adherence to DOACs is essential to achieve effective levels of anticoagulation. It has been reported that up to 28% of patients treated with dabigatan for AF had poor adherence (proportion of days covered <80%). In a recent study including 500 AF patients, 43% and 44% of them, respectively treated with VKA and DOACs, self-reported non adherence to their anticoagulation treatment . Lower adherence is associated with a greater risk for combined all-cause mortality and stroke in AF patients .
The aim of this study is to evaluate a specific dosage of anticoagulation level to detect non adherence to oral anticoagulant treatment in AF patients treated with anti factor Xa inhibitor.
One hundred and fifty consecutive AF patients treated with either rivaroxaban 20 mg or 15 mg once daily or apixaban 5 mg or 2.5 mg twice daily and not meeting exclusion criteria will be included in this study.
Planned and unplanned admissions. Patients will have to be under ACODs regimen for at least 30 days before inclusion.
Informed consent will be given. Blood sample with specific anti factor Xa activity dosage will be performed. Thereafter, adherence to oral anticoagulant treatment will be evaluated using biological results. Primary endpoint will be the prevalence of medication nonadherence based on anti factor Xa activity below therapeutic level at time of admission
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Fibrillation
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
patient with atrial fibrillation
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Adherence to oral anticoagulant treatment
Intervention Description
The adherence will be evaluated by biological results
Primary Outcome Measure Information:
Title
Anti factor Xa activity dosage
Description
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).
Time Frame
one day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
Valvular atrial fibrillation (i.e. mitral stenosis, valvular prosthesis).
Pregnancy or breast feeding
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Urielle DESALBRES
Organizational Affiliation
Assistance Publique Hôpitaux de Marseille
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
We'll reach out to this number within 24 hrs