- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02286414
Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over (PRESAGE-ACO)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75018
- Assistance Publique Hopitaux de Paris
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- Opposition of the patient to the collection of his personal data
- Follow-up deemed impossible
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Exposed group
Patients recieving direct oral anticoagulants (DOA)
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Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban
Other Names:
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Non-exposed group
Patients recieving vitamine K antagonists (VKA)
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Exposure to vitamin K antagonist
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Composite of major bleeding events or thromboembolic events or death from any cause
Time Frame: 2 years at least
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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.
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2 years at least
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Major bleeding eventThromboembolic event
Time Frame: 2 years at least
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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)
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2 years at least
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Thromboembolic event
Time Frame: 2 years at least
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Ischemic stroke, systemic or pulmonary embolism
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2 years at least
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All adverse events
Time Frame: 2 years at least
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All adverse events
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2 years at least
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Risk factors of TE events or major bleeding events
Time Frame: 2 years at least
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Risk factors of TE events or major bleeding events
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2 years at least
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Patterns of use of oral anticoagulants
Time Frame: 2 years at least
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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
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2 years at least
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Collaborators and Investigators
Investigators
- Principal Investigator: Florence Tubach, PhD, Assistance Publique - Hôpitaux de Paris
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Heart Diseases
- Cardiovascular Diseases
- Arrhythmias, Cardiac
- Atrial Fibrillation
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Fibrin Modulating Agents
- Protease Inhibitors
- Micronutrients
- Factor Xa Inhibitors
- Antithrombins
- Serine Proteinase Inhibitors
- Anticoagulants
- Antifibrinolytic Agents
- Hemostatics
- Coagulants
- Vitamin K
- Rivaroxaban
- Dabigatran
- Apixaban
- Vitamins
- Warfarin
- Acenocoumarol
- Fluindione
Other Study ID Numbers
- AOM13472
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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