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

NCT02286414 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 159

Last updated 2022-03-29

No results posted yet for this study

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

Interventions

DRUG

Direct oral antocoagulant: dabigatran, rivaroxaban, apixaban

Exposure to direct oral antocoagulants : dabigatran, rivaroxaban, apixaban

DRUG

Vitamin K antagonist: warfarin, fluindione, acenocoumarol

Exposure to vitamin K antagonist

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Florence Tubach, PhD · Assistance Publique - Hôpitaux de Paris

Eligibility

Min Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-02-28
Primary Completion
2021-11-30
Completion
2021-11-30

Countries

  • France

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02286414 on ClinicalTrials.gov