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

NCT03790917 | Completed Results

• 1 other identifier: ANTEY
• Study Type: observational
• Target: 201
• Locations: 1 country
• Sites: 1

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. 1.Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
2. 2.Evaluation of actual patient adherence to OACs
3. 3.Evaluation of potential patient adherence to OACs
4. 4.Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
5. 5.Validation of new original 5-item Questionnaire
6. 6.Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)

Conditions

Atrial Fibrillation

Keywords

adherence; new oral anticoagulants (NOACs); AF

Outcome Measures

Primary Outcomes (2)

• Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)

  The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during V1 with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale.

  6 months

• Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)

  The study consisted of two visits half a year apart (V0, V1) and a phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Adherence to therapy was assessed during phone contact with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale. Out of 201 participants of the study 4 patients died and 197 patients completed the study.

  1 year

Secondary Outcomes (5)

• Proportion of Potentially Adherent Patients

  Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

• Proportion of OACs Prescribed by Doctors According to Guidelines

  Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

• The Main Reasons for Refusing to Start NOAC Therapy

  Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

• Reasons for Stopping Oral Anticoagulants (Data From Visit 1)

  Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))

• Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)

  Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Research Center for Preventive Medicine: lead

Study Sites (1)

National Research Center for Preventive Medicine

Moscow, 101990, Russia

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: professor Sergey Yu. Martsevich
• Organization: National Medical Research Center for Preventive Medicine

sergeymartsevich@mail.ru

89161643690

Study Officials

• Sergey Martsevich, MD,PhD

  National Research Center of Preventive Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2018
• First Posted: January 2, 2019
• Study Start: September 5, 2017
• Primary Completion: December 28, 2018
• Study Completion: December 28, 2018
• Last Updated: July 16, 2020
• Results First Posted: June 9, 2020

Record last verified: 2020-05

Locations

RU (1)