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

NCT02286414 | Completed

• 1 other identifier: AOM13472
• Study Type: observational
• Target: 159
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

oral anticoagulants; Geriatrics; General Practitioner; Safety; Misuse

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Exposed group

Patients recieving direct oral anticoagulants (DOA)

Drug: Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban

Non-exposed group

Patients recieving vitamine K antagonists (VKA)

Drug: Vitamin K antagonist: warfarin, fluindione, acenocoumarol

Interventions

Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban DRUG

Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban

Also known as: Direct oral antocoagulant

Exposed group

Vitamin K antagonist: warfarin, fluindione, acenocoumarol DRUG

Exposure to vitamin K antagonist

Also known as: Vitamin K antagonist

Non-exposed group

Eligibility Criteria

• Age: 80 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• Opposition of the patient to the collection of his personal data
• Follow-up deemed impossible

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Assistance Publique Hôpitaux de Paris

Paris, 75018, France

Location

MeSH Terms

Conditions

Atrial Fibrillation

Interventions

Rivaroxaban; apixaban; fluindione; Acenocoumarol; acarboxyprothrombin

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Florence Tubach, PhD

  Assistance Publique - Hôpitaux de Paris

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2014
• First Posted: November 7, 2014
• Study Start: February 1, 2015
• Primary Completion: November 1, 2021
• Study Completion: November 1, 2021
• Last Updated: March 29, 2022

Record last verified: 2022-03

Locations

FR (1)