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

NCT ID: NCT03790917

Last Updated: 2020-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 201 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-05
• Study Completion Date: 2018-12-28

Brief 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

Atrial Fibrillation

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Men and women above 18 years of age who were included in the PROFILE registry by the start of the observational study
• Presence of written informed consent to participate in the study, fill in the study questionnaires and have personal data analyzed
• Presence of any form of non-valvular atrial fibrillation with CHA2DS2-VASc score of ≥1 or patients with CHA2DS2-VASc score = 0, who are already taking OAK

Exclusion Criteria

• Patients with high bleeding risk, including patients with:

• Congenital or acquired bleeding disorders
• Uncontrolled resistant hypertension
• Exacerbation of gastric and duodenal ulcer
• Vascular retinopathy
• Recent history of intracranial or intracerebral hemorrhage
• Pathology of the brain and spinal cord vessels
• Recent history of brain, spinal cord or eye surgery
• History of bronchiectasis or pulmonary hemorrhage
• A CHA2DS2-VASc score of 0 (OACs are not indicated)
• Pregnancy, lactation
• Planned surgery
• Known hypersensitivity to ingredients of medications used in the study

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Research Center for Preventive Medicine

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sergey Martsevich, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

National Research Center of Preventive Medicine

Locations

National Research Center for Preventive Medicine

Moscow, , Russia

Countries

Russia

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

ANTEY

Identifier Type: -

Identifier Source: org_study_id