Atrial FibrillationPRESAGE-ACONCT02286414
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over
An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living… Read more about this study
- Who is it for?
- Ages 80 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban and Vitamin K antagonist: warfarin, fluindione, acenocoumarol
- Type of treatment
- Pill or oral medicine
- How many people
- 159 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2015to Nov 2021
- Phase
- Observational
- 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 80 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Consecutive patients aged 80 years or more, newly treated with oral anticoagulants for nv AF or for flutter, living in community or in nursing home
Who may be able to join
- Aged 80 years and over
- Newly treated with oral anticoagulants (DOA or VKA) for nv AF (whatever its type) or for flutter
- Living in community or in nursing home
- And consulting a general practionner (GP) and/or a pharmacist participating to the Presage network
Who cannot join
- Opposition of the patient to the collection of his personal data
- Follow-up deemed impossible
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study
The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.
An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years at least.
Read the detailed description
- Context: Oral anticoagulation is recommended for prevention of stroke and thrombo-embolic events in people aged 80 years and over (octo+) suffering from non vavular atrial fibrillation (nv AF) and without contraindication to anticoagulant therapy. Two drug classes are available to achieve this oral anticoagulation: the vitaminK antagonists (VKA, warfarin, fluindione and acenocoumarol) or the direct oral anticoagulants (DOA, dabigatran, rivaroxaban and apixaban). The data of evidence-based and post-marketing literature on the benefit/risk ratio of DOA comparatively to VKA are limited, conflicting, potentially biased and finally inconclusive in this population. Nevertheless, octo+ are the age bracket the most at risk for nv AF and the population with the highest risk of both anticoagulant-related major bleedings and AF-related thrombotic (TE) events.
- Objectives: The aim of the study is to assess and compare the real benefits and harms of the two therapeutic strategies available in routine practice, for the anticoagulation in octo+ suffering from nvAF. The main objective is to estimate and compare a composite event including major bleeding, TE events and death from any cause of DOA and VKA in octo+ suffering from nv AF and living in community or nursing home settings. The secondary objectives are, in this population: to estimate and compare the composite event of each DOA (dabigatran, rivaroxaban, and apixaban) with the composite event of VKA, to estimate and compare the rate of occurrence of each component of the composite event in patients exposed to DOA as compared to patients exposed to VKA, to identify factors associated with the occurrence of major bleeding events and TE events in patients exposed to oral anticoagulants (OAC), to describe others adverse drug reactions (ADRs) (not serious bleeding and TE events; other serious or not serious ADRs) and to provide related rates in users of VKA and DOA as well as individual DOA, to describe the utilization patterns of oral anticoagulants.
- Design: An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults.
- Conditions
- Atrial Fibrillation
- Being tested
- Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban, Vitamin K antagonist: warfarin, fluindione, acenocoumarol
- Keywords
- oral anticoagulants, Geriatrics, General Practitioner, Safety, Misuse
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct oral antocoagulant: dabigatran, rivaroxaban, apixabanDrug
Also called Direct oral antocoagulant
Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban
Vitamin K antagonist: warfarin, fluindione, acenocoumarolDrug
Also called Vitamin K antagonist
Exposure to vitamin K antagonist
| Study group | Role | What they receive |
|---|---|---|
| Exposed group | Patients recieving direct oral anticoagulants (DOA) Receives: Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban | |
| Non-exposed group | Patients recieving vitamine K antagonists (VKA) Receives: Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite of major bleeding events or thromboembolic events or death from any cause
Major bleeding is defined as a bleeding resulting in death, requiring hospital admission, resulting in persistent or significant disability/incapacity, or being life threatening, according to the WHO definition of seriousness of Adverse Drug Reactions (ADRs). Thromboembolic events (TE) include: Ischemic stroke, systemic or pulmonary embolism.
Measured: 2 years at least
Secondary outcomes (5)
Major bleeding eventThromboembolic event
Bleeding resulting in death, requiring hospital admission, resulting in persistent or significant disability/incapacity, or being life threatening, according to the WHO definition of seriousness of Adverse Drug Reactions (ADRs)
Measured: 2 years at least
Thromboembolic event
Ischemic stroke, systemic or pulmonary embolism
Measured: 2 years at least
All adverse events
All adverse events
Measured: 2 years at least
Risk factors of TE events or major bleeding events
Risk factors of TE events or major bleeding events
Measured: 2 years at least
Patterns of use of oral anticoagulants
Pattern of use will be described by: characteristics of the treated population (age, comorbidities), drug indication, dose and regimen, time on treatment, reason of discontinuation where applicable, concomitant drugs
Measured: 2 years at least
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2014 (estimated)
- Study startFeb 2015
- Primary completionNov 2021
- Study completionNov 2021
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 - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florence Tubach, PhD, Principal investigator, Assistance Publique - Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02286414
- Sponsor's protocol ID
- AOM13472
- Acronym
- PRESAGE-ACO
- Status last verified
- Mar 2022
- First submitted
- 5 Nov 2014
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in the Treatment of Non Valvular Atrial Fibrillation in Patients Aged 80 Years and Over, Living at Home or in Nursing Home. A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT02286414
- Acronym / sponsor ID
- PRESAGE-ACO / AOM13472
- Conditions
- Atrial Fibrillation
- Keywords
- oral anticoagulants, Geriatrics, General Practitioner, Safety, Misuse
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Feb 2015 (actual)
- Primary completion
- Nov 2021 (actual)
- Study completion
- Nov 2021 (actual)
- First posted
- 7 Nov 2014 (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.
The aim of the study is to compare, in real life, the risk benefit (including both major bleeding and thrombotic events (TE) and death from any cause) associated with direct oral anticoagulants (DOA) and with anti vitamin K (VKA) in older adults (≥ 80 years) suffering from non valvular atrial fibrillation and living in community or nursing home settings.
An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults. GPs and pharmacists will prospectively include all octo+ patients they care for, newly treated with an oral anticoagulant (VKA or DOA) for nv AF and will follow them during 2 years at least.
Detailed description
- Context: Oral anticoagulation is recommended for prevention of stroke and thrombo-embolic events in people aged 80 years and over (octo+) suffering from non vavular atrial fibrillation (nv AF) and without contraindication to anticoagulant therapy. Two drug classes are available to achieve this oral anticoagulation: the vitaminK antagonists (VKA, warfarin, fluindione and acenocoumarol) or the direct oral anticoagulants (DOA, dabigatran, rivaroxaban and apixaban). The data of evidence-based and post-marketing literature on the benefit/risk ratio of DOA comparatively to VKA are limited, conflicting, potentially biased and finally inconclusive in this population. Nevertheless, octo+ are the age bracket the most at risk for nv AF and the population with the highest risk of both anticoagulant-related major bleedings and AF-related thrombotic (TE) events.
- Objectives: The aim of the study is to assess and compare the real benefits and harms of the two therapeutic strategies available in routine practice, for the anticoagulation in octo+ suffering from nvAF. The main objective is to estimate and compare a composite event including major bleeding, TE events and death from any cause of DOA and VKA in octo+ suffering from nv AF and living in community or nursing home settings. The secondary objectives are, in this population: to estimate and compare the composite event of each DOA (dabigatran, rivaroxaban, and apixaban) with the composite event of VKA, to estimate and compare the rate of occurrence of each component of the composite event in patients exposed to DOA as compared to patients exposed to VKA, to identify factors associated with the occurrence of major bleeding events and TE events in patients exposed to oral anticoagulants (OAC), to describe others adverse drug reactions (ADRs) (not serious bleeding and TE events; other serious or not serious ADRs) and to provide related rates in users of VKA and DOA as well as individual DOA, to describe the utilization patterns of oral anticoagulants.
- Design: An observational multicenter prospective inception cohort will be conducted within the PRESAGE-Network, an ongoing active network on drug safety in older adults in France involving a sample of general practitioners (GPs) and pharmacists, for an active surveillance of drug safety in older adults.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixabanPatients recieving direct oral anticoagulants (DOA) |
| Non-exposed group | – | Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarolPatients recieving vitamine K antagonists (VKA) |
Who may qualify
- Ages
- 80 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Consecutive patients aged 80 years or more, newly treated with oral anticoagulants for nv AF or for flutter, living in community or in nursing home
Key inclusion criteria (4 listed)
- Aged 80 years and over
- Newly treated with oral anticoagulants (DOA or VKA) for nv AF (whatever its type) or for flutter
- Living in community or in nursing home
- And consulting a general practionner (GP) and/or a pharmacist participating to the Presage network
Key exclusion criteria (2 listed)
- Opposition of the patient to the collection of his personal data
- Follow-up deemed impossible
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 |
|---|---|---|
| Direct oral antocoagulant: dabigatran, rivaroxaban, apixabanAlso: Direct oral antocoagulantExposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban | Drug | Exposed group |
| Vitamin K antagonist: warfarin, fluindione, acenocoumarolAlso: Vitamin K antagonistExposure to vitamin K antagonist | Drug | Non-exposed group |
Primary outcome
Composite of major bleeding events or thromboembolic events or death from any cause
Time frame: 2 years at least
Major bleeding is defined as a bleeding resulting in death, requiring hospital admission, resulting in persistent or significant disability/incapacity, or being life threatening, according to the WHO definition of seriousness of Adverse Drug Reactions (ADRs). Thromboembolic events (TE) include: Ischemic stroke, systemic or pulmonary embolism.
5 secondary outcomes
Major bleeding eventThromboembolic event
Time frame: 2 years at least
Thromboembolic event
Time frame: 2 years at least
All adverse events
Time frame: 2 years at least
Risk factors of TE events or major bleeding events
Time frame: 2 years at least
Patterns of use of oral anticoagulants
Time frame: 2 years at least
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 29 Mar 2022.
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Paroxysmal AF
Active, not recruitingObservational study
Concomitant Left Atrial Appendage Closure and Pulsed Field Ablation-Asia
Concomitant Procedures, Atrial Fibrillation
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CONVERGE Post-Approval Study (PAS)
Chronic Atrial Fibrillation
Recruiting
Early Closure of Left Atrial Appendage for Patients With Atrial Fibrillation and Ischemic Stroke Despite Anticoagulation Therapy
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RecruitingPhase 2
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Atrial Fibrillation (AF)
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.
Florence Tubach, PhD principal investigator
Assistance Publique - Hôpitaux de Paris
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
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 4 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 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Composite of major bleeding events or thromboembolic events or death from any cause (time frame: 2 years at least). 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 29 Mar 2022.