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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exposed group | Patients recieving direct oral anticoagulants (DOA) |
| |
| Non-exposed group | Patients recieving vitamine K antagonists (VKA) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban | Drug | Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 2 years at least |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 2 years at least |
| Thromboembolic event |
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Inclusion Criteria:
Exclusion Criteria:
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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
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| Name | Affiliation | Role |
|---|---|---|
| Florence Tubach, PhD | Assistance Publique - Hôpitaux de Paris | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assistance Publique Hôpitaux de Paris | Paris | 75018 | France |
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| Vitamin K antagonist: warfarin, fluindione, acenocoumarol | Drug | Exposure to vitamin K antagonist |
|
|
Ischemic stroke, systemic or pulmonary embolism |
| 2 years at least |
| All adverse events | All adverse events | 2 years at least |
| Risk factors of TE events or major bleeding events | Risk factors of TE events or major bleeding events | 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 | 2 years at least |
| ID | Term |
|---|---|
| D001281 | Atrial Fibrillation |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069552 | Rivaroxaban |
| C522181 | apixaban |
| C017673 | fluindione |
| D000074 | Acenocoumarol |
| C008208 | acarboxyprothrombin |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D015110 | 4-Hydroxycoumarins |
| D003374 | Coumarins |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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