Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over (PRESAGE-ACO)
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|ClinicalTrials.gov Identifier: NCT02286414|
Recruitment Status : Recruiting
First Posted : November 7, 2014
Last Update Posted : January 21, 2020
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.
|Condition or disease||Intervention/treatment|
|Atrial Fibrillation||Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol|
- 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 :||Observational|
|Estimated Enrollment :||2193 participants|
|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|
|Actual Study Start Date :||February 2015|
|Estimated Primary Completion Date :||November 2021|
|Estimated Study Completion Date :||November 2021|
Patients recieving direct oral anticoagulants (DOA)
Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban
Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban
Other Name: Direct oral antocoagulant
Patients recieving vitamine K antagonists (VKA)
Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol
Exposure to vitamin K antagonist
Other Name: Vitamin K antagonist
- 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.
- Major bleeding eventThromboembolic event [ Time Frame: 2 years at least ]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 event [ Time Frame: 2 years at least ]Ischemic stroke, systemic or pulmonary embolism
- All adverse events [ Time Frame: 2 years at least ]All adverse events
- Risk factors of TE events or major bleeding events [ Time Frame: 2 years at least ]Risk factors of TE events or major bleeding events
- Patterns of use of oral anticoagulants [ Time Frame: 2 years at least ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02286414
|Contact: Florence Tubach, PhD||+33 (0) 142 160 firstname.lastname@example.org|
|Assistance Publique Hôpitaux de Paris||Recruiting|
|Paris, France, 75018|
|Contact: Florence Tubach, MD, PhD|
|Principal Investigator:||Florence Tubach, PhD||Assistance Publique - Hôpitaux de Paris|