An observational study in Atrial Fibrillation, sponsored by National Research Center for Preventive Medicine. Completed at 1 site in Russian Federation. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-16.
Sponsored by National Research Center for Preventive Medicine · Observational
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).
Secondary Study Objective(s)
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).
3,870 studies on the registry are indexed under Atrial Fibrillation; 924 are open to participants now.
This study's enrollment of 201 is below the median of 300 across 1,363 observational studies indexed under Atrial Fibrillation.
Browse Atrial Fibrillation studies →National Research Center for Preventive Medicine is the lead sponsor of 18 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.
Exclusion Criteria:
Patients with high bleeding risk, including patients with:
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.
Time frame: 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.
Time frame: 1 year
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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. 1. Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more. 2. Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more. 3. Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk. 4. 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). 5. In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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).
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
| Milestone | ANTEY |
|---|---|
| Started | 201 |
| Completed | 200 |
| Not completed | 1 |
| Withdrew: Death | 1 |
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.
| Participants | ANTEY |
|---|---|
| completely adherent | 155 |
| partially adherent | 5 |
| partially non-adherent | 7 |
| completely non-adherent | 33 |
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.
| Participants | ANTEY |
|---|---|
| completely adherent | 158 |
| partially adherent | 6 |
| partially non-adherent | 18 |
| completely non-adherent | 15 |
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.
| Participants | ANTEY |
|---|---|
| completely adherent | 161 |
| partially adherent | 28 |
| completely non-adherent | 12 |
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. 1. Oral anticoagulation therapy to prevent thromboembolism is recommended for all male AF patients with a CHA2DS2-VASc score of 2 or more. 2. Oral anticoagulation therapy to prevent thromboembolism is recommended in all female AF patients with a CHA2DS2-VASc score of 3 or more. 3. Antiplatelet monotherapy is not recommended for stroke prevention in AF patients, regardless of stroke risk. 4. 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). 5. In male or female AF patients without additional stroke risk factors, anticoagulant or antiplatelet therapy is not recommended for stroke prevention.
| Participants | ANTEY |
|---|---|
| OACs were recommended by doctors | 171 |
| OACs were not recommended by doctors | 30 |
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.
| Participants | ANTEY |
|---|---|
| high price of NOAC | 14 |
| fear of adverse events | 6 |
| doubts about the correctness of prescribtion | 5 |
| adherence to Warfarin | 2 |
| adherence to another NOAC | 2 |
| difficult regimen for all drugs | 2 |
| lack of NOAC in the preferential drug list | 2 |
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).
| Participants | ANTEY |
|---|---|
| bleeding | 5 |
| cancellation by another doctor | 1 |
| high cost | 1 |
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.
| Participants | ANTEY |
|---|---|
| bleeding | 7 |
| cancellation by another doctor | 6 |
| high cost | 2 |
| others | 3 |
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ANTEY | 4/201 (2%) | 21/201 (10.4%) | 30/201 (14.9%) |
| Event | ANTEY |
|---|---|
| Unstable angina pectorisCardiac disorders | 5/201 |
| CHF decompensationCardiac disorders | 5/201 |
| Paroxysm of atrial fibrillationCardiac disorders | 5/201 |
| StrokeNervous system disorders | 2/201 |
| Acute myiocardial infarctionCardiac disorders | 1/201 |
| SarcomaNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/201 |
| Bleeding in the retinaEye disorders | 1/201 |
| Iron deficiency anaemiaBlood and lymphatic system disorders | 1/201 |
| Event | ANTEY |
|---|---|
| BleedingGeneral disorders | 18/201 |
| NauseaGastrointestinal disorders | 4/201 |
| UrticariaImmune system disorders | 2/201 |
| ObstipationGastrointestinal disorders | 2/201 |
| HypothyroidismEndocrine disorders | 1/201 |
| CoughRespiratory, thoracic and mediastinal disorders | 1/201 |
| GynecomastiaReproductive system and breast disorders | 1/201 |
| Arterial hypotensionCardiac disorders | 1/201 |
| Age, Continuous(years) | ANTEY |
|---|---|
| Mean | 71.1 ± 8.7 |
| Sex: Female, Male(Participants) | ANTEY |
|---|---|
| Female | 83 |
| Male | 118 |
| Race (NIH/OMB)(Participants) | ANTEY |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 201 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | ANTEY |
|---|---|
| Russia | 201 |
| NOAC recommended to patients by doctors during V0(Participants) | ANTEY |
|---|---|
| rivaroxaban | 111 |
| dabigatran | 47 |
| apixaban | 43 |
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