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OpenTrials
Completed

NCT Number: NCT05469308

Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation

The rhythm disorders of Atrial Fibrillation (AF) require continuous treatment with anticoagulants to prevent stroke. The introduction of direct oral anticoagulants (DOACs) quickly supplanted the administration of anti-vitamin K (AVK) which presented an elevated risk of hemorrhage.

However, the adherence of the treatments by the OAD is very poor, several studies show that 30 to 50% of the patients fail to adhere to their treatment very soon after starting it. In a recent study, in the United States, using data collected between 2010 and 2014 in more than 60,000 patients with AF, Yao et al show that less than 50% of patients can be considered "adherent".

They conclude in this study that adherence to anticoagulation is low in practice, although it may be slightly improved with DOACs. More recently a meta-analysis shows that 66% of patient treated by DOACs were considered adherent (PDC > 80 %). In addition, therapeutic adherence seems to be essential in patients with a CHA2DS2-VASc score ≥2. Indeed improving adherence reduces the risk of stroke occurrence. The investigators propose to evaluate during an interview in the pharmacy, the adherence of ambulatory patients (at the time of their renewal of treatment at the pharmacy) by the "Proportion of Days Covered" (PDC) of the treatment by AOD, and by a simplified questionnaire and to define a profile of patients treated for AF at risk of nonadherence to AOD (PDC adherence prediction score). The investigators perform an observational, prospective multicenter study , in which patients adherence will be quantified in a standardized method.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80480, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Over the age of 18
  • Consultation in the community pharmacy
  • long-term treatment for at least six months with an DOACs.
  • Patients able and agreeing to participate in the evaluation of their adherence

Exclusion criteria

  • Treatment by DOACs limited in the duration
  • Contra-indications of DOACs

Treatment and study plan

questionary

Other

When the patients renew their treatment in community pharmacy, they have an adherence record with a pharmacist who calculates the PDC score, and perform questionaries on adherence to the DOACs, and collects data about clinical history and pharmacological information on the prescribed DAOCs, demography.

Primary outcomes

  1. Number of AOD specific PDC

    Time frame: 2 years

    Determination of the AOD (Direct oral anticoagulants) specific PDC (Proportion of Days Covered) of patients coming to renew their treatment in the community pharmacy

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Official study title

Predictivity and Evaluation of the Adherence of Ambulatory Patients Treated With a Direct Oral Anticoagulant for Atrial Fibrillation

Acronym: 3AOD

Important dates

Study start
2022
Primary completion
2024
Study completion
2025
First posted
Jul 21, 2022
Registry last updated
Jun 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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