Benefit/Risk in Real Life of New Oral Anticoagulants and Vitamin K Antagonists in Patients Aged 80 Years and Over

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

Sponsors

Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Source Assistance Publique - Hôpitaux de Paris
Brief 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 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.

Overall Status Recruiting
Start Date 2015-02-01
Completion Date 2021-11-01
Primary Completion Date 2021-11-01
Study Type Observational
Primary Outcome
Measure Time Frame
Composite of major bleeding events or thromboembolic events or death from any cause 2 years at least
Secondary Outcome
Measure Time Frame
Major bleeding eventThromboembolic event 2 years at least
Thromboembolic event 2 years at least
All adverse events 2 years at least
Risk factors of TE events or major bleeding events 2 years at least
Patterns of use of oral anticoagulants 2 years at least
Enrollment 2193
Condition
Intervention

Intervention Type: Drug

Intervention Name: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban

Description: Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban

Arm Group Label: Exposed group

Other Name: Direct oral antocoagulant

Intervention Type: Drug

Intervention Name: Vitamin K antagonist: warfarin, fluindione, acenocoumarol

Description: Exposure to vitamin K antagonist

Arm Group Label: Non-exposed group

Other Name: Vitamin K antagonist

Eligibility

Sampling Method: Non-Probability Sample

Criteria:

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

Gender: All

Minimum Age: 80 Years

Maximum Age: N/A

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Florence Tubach, PhD Principal Investigator Assistance Publique - Hôpitaux de Paris
Overall Contact

Last Name: Florence Tubach, PhD

Phone: +33 (0) 142 160 588

Email: [email protected]

Location
Facility: Status: Contact: Assistance Publique Hôpitaux de Paris Florence Tubach, MD, PhD
Location Countries

France

Verification Date

2020-01-01

Responsible Party

Type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Arm Group

Label: Exposed group

Description: Patients recieving direct oral anticoagulants (DOA)

Label: Non-exposed group

Description: Patients recieving vitamine K antagonists (VKA)

Acronym PRESAGE-ACO
Study Design Info

Observational Model: Cohort

Time Perspective: Prospective

Source: ClinicalTrials.gov

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