Clinical Trials Directory

Trials / Completed

CompletedNCT03790917

Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY

Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study

Status
Completed
Phase
Study type
Observational
Enrollment
201 (actual)
Sponsor
National Research Center for Preventive Medicine · Other Government
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

A prospective non-interventional single-centre study aimed to evaluate actual adherence of AF patients using the validated adherence Scale. Primary Study Objective(s) Primary study objective The aim of the present study is to assess adherence to therapy and factors associated with adherence in patients with CV disease complicated by non-valvular atrial fibrillation requiring OAC treatment within the outpatient registry PROFILE (prospective, observational study). 1. Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry 2. Evaluation of actual patient adherence to OACs Secondary Study Objective(s) 1. Evaluation of potential patient adherence to OACs 2. Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF 3. Validation of new original 5-item Questionnaire 4. Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)

Detailed description

AF patients from ongoing PROFILE registry will be invited to visit the scientific center. 2 visits with a 6-month interval are expected for each patient as part of routine clinical practice and phone contact is scheduled for each patient 1 year from the first visit to the scientific center (follow-up period).

Conditions

Timeline

Start date
2017-09-05
Primary completion
2018-12-28
Completion
2018-12-28
First posted
2019-01-02
Last updated
2020-07-16
Results posted
2020-06-09

Locations

1 site across 1 country: Russia

Source: ClinicalTrials.gov record NCT03790917. Inclusion in this directory is not an endorsement.