Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over (PRESAGE-ACO)

March 28, 2022 updated by: Assistance Publique - Hôpitaux de Paris

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

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

Observational

Enrollment (Actual)

159

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Paris, France, 75018
        • Assistance Publique Hopitaux de Paris

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

78 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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)
Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban
Other Names:
  • Direct oral antocoagulant
Non-exposed group
Patients recieving vitamine K antagonists (VKA)
Exposure to vitamin K antagonist
Other Names:
  • Vitamin K antagonist

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
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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
2 years at least
Thromboembolic event
Time Frame: 2 years at least
Ischemic stroke, systemic or pulmonary embolism
2 years at least
All adverse events
Time Frame: 2 years at least
All adverse events
2 years at least
Risk factors of TE events or major bleeding events
Time Frame: 2 years at least
Risk factors of TE events or major bleeding events
2 years at least
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
2 years at least

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Florence Tubach, PhD, Assistance Publique - Hôpitaux de Paris

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2015

Primary Completion (Actual)

November 1, 2021

Study Completion (Actual)

November 1, 2021

Study Registration Dates

First Submitted

November 5, 2014

First Submitted That Met QC Criteria

November 5, 2014

First Posted (Estimate)

November 7, 2014

Study Record Updates

Last Update Posted (Actual)

March 29, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

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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