Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation

Not Applicable

• Conditions: Adherence; Oral Anticoagulant
• Interventions: Other: questionary

• Registration Number: NCT05469308
• Lead Sponsor: Centre Hospitalier Universitaire, Amiens

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-06
• Study Start: 2022-06-10
• Study First Submitted: 2022-07-19
• Study First Submitted QC: 2022-07-19
• Study First Posted: 2022-07-21
• Last Update Submitted: 2022-07-27
• Last Update Posted: 2022-07-29
• Primary Completion: 2024-06
• Study Completion: 2024-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 705

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
questionary	questionary	-

Primary Outcome Measures

Name	Time	Method
Number of AOD specific PDC	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

Trial Locations

Locations (1)

CHU Amiens; 🇫🇷 Amiens, France