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Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation

NCT05469308 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 705

Last updated 2022-07-29

No results posted yet for this study

Summary

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.

Conditions

  • Oral Anticoagulant
  • Adherence

Interventions

OTHER

questionary

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.

Sponsors & Collaborators

  • Centre Hospitalier Universitaire, Amiens

    lead OTHER

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-10
Primary Completion
2024-06-30
Completion
2024-06-30

Countries

  • France

Study Locations

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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 NCT05469308 on ClinicalTrials.gov