Atrial FibrillationNCT02925247
Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
A study testing Adherence to oral anticoagulant treatment in people with Atrial Fibrillation, run by Assistance Publique Hopitaux De Marseille.
Trial 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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Adherence to oral anticoagulant treatment
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 27 Nov 2016to 18 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Valvular atrial fibrillation (i.e. mitral stenosis, valvular prosthesis).
- Pregnancy or breast feeding
About this study
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
Read the 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
- Conditions
- Atrial Fibrillation
- Being tested
- Adherence to oral anticoagulant treatment
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adherence to oral anticoagulant treatmentBehavioural
The adherence will be evaluated by biological results
| Study group | Role | What they receive |
|---|---|---|
| patient with atrial fibrillation | Other | Not described Receives: Behavioral: Adherence to oral anticoagulant treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2016 (estimated)
- Study start27 Nov 2016
- Primary completion19 Nov 2018
- Study completion18 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Urielle DESALBRES, Study director, Assistance Publique Hôpitaux de Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925247
- Sponsor's protocol ID
- 2016-10
- Status last verified
- Apr 2023
- First submitted
- 4 Oct 2016
- Last updated
- 7 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Specific Anti Factor Xa Activity Dosage to Enhance Detection of Nonadherence in Atrial Fibrillation Patients
- ClinicalTrials.gov ID
- NCT02925247
- Acronym / sponsor ID
- 2016-10
- Conditions
- Atrial Fibrillation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 27 Nov 2016 (actual)
- Primary completion
- 19 Nov 2018 (actual)
- Study completion
- 18 Nov 2022 (actual)
- First posted
- 5 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patient with atrial fibrillation | Other | Behavioral: Adherence to oral anticoagulant treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- Valvular atrial fibrillation (i.e. mitral stenosis, valvular prosthesis).
- Pregnancy or breast feeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adherence to oral anticoagulant treatmentThe adherence will be evaluated by biological results | Behavioural | patient with atrial fibrillation |
Primary outcome
Anti factor Xa activity dosage
Time frame: one day
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Urielle DESALBRES study director
Assistance Publique Hôpitaux de Marseille
Questions about this trial
What is this clinical trial studying?
A study testing Adherence to oral anticoagulant treatment in people with Atrial Fibrillation, run by Assistance Publique Hopitaux De Marseille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anti factor Xa activity dosage (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2023.