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

Atrial Fibrillation Clinical Trial

— ANTEY  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03790917
• Other study ID #: ANTEY
• Status: Completed
• Start date: September 5, 2017
• Est. completion date: December 28, 2018

Study information

• Verified date: May 2020
• Source: National Research Center for Preventive Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 201
• Est. completion date: December 28, 2018
• Est. primary completion date: December 28, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Russian Federation	National Research Center for Preventive Medicine	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
National Research Center for Preventive Medicine

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Proportion of Potentially Adherent Patients	Specifically designed 5-item questionnaire was used for assessment of potential adherence to OACs. According to results patients were divided into groups: completely adherent, partially adherent, completely non-adherent to OACs.	Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Secondary	Proportion of OACs Prescribed by Doctors According to Guidelines	Prescription of OACs according to guidelines was considered "positive" if it matched the key points of 2016 ESC Guidelines for the management of atrial fibrillation.; Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more.; Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more.; Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk.; NOACs (apixaban, dabigatran, edoxaban, and rivaroxaban) are not recommended in patients with mechanical heart valves (Level of evidence B) or moderate-to-severe mitral stenosis (Level of evidence C).; In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.	Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Secondary	The Main Reasons for Refusing to Start NOAC Therapy	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. Patients refusing to start NOAC treatmet were asked about the reasons to refuse NOAC treatment.	Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Secondary	Reasons for Stopping Oral Anticoagulants (Data From Visit 1)	The study consisted of two visits half a year apart (V0, V1) and phone contact (PC) one year after V0. During V0 all patients were recommended to start therapy with one of the NOACs. Patients who stopped or didn't start NOAC treatment were asked about the reasons for non-adherence to anticoagulants use during visit 1 (6 months) and at PC (1 year).	Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
Secondary	Reasons for Stopping Oral Anticoagulants (Data From the 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. Patients who stopped NOAC treatmet were asked about the reasons for stopping oral anticoagulants (NOAC and warfarin) use during the phone contact.	Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)