Overview

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

Status:
Recruiting

Trial end date:
2021-11-01

Target enrollment:
0

Participant gender:
All

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.

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Assistance Publique - Hôpitaux de Paris

Treatments:

Acenocoumarol
Anticoagulants
Apixaban
Dabigatran
Fluindione
Rivaroxaban
Vitamin K
Vitamins
Warfarin

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