3AOD: Adherence to Oral Anticoagulants in Patients With Atrial Fibrillation

Sponsor
Centre Hospitalier Universitaire, Amiens (Other)
Overall Status
Recruiting
CT.gov ID
NCT05469308
Collaborator
(none)
705
1
1
23.7
29.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: questionary
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
705 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
Official Title:
Predictivity and Evaluation of the Adherence of Ambulatory Patients Treated With a Direct Oral Anticoagulant for Atrial Fibrillation
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Jun 1, 2024
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: questionary

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.

Outcome Measures

Primary Outcome Measures

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU Amiens Amiens France 80480

Sponsors and Collaborators

  • Centre Hospitalier Universitaire, Amiens

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire, Amiens
ClinicalTrials.gov Identifier:
NCT05469308
Other Study ID Numbers:
  • PI2022_843_0020
First Posted:
Jul 21, 2022
Last Update Posted:
Jul 29, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Centre Hospitalier Universitaire, Amiens
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 29, 2022