Atrial Fibrillation
Conditions
Keywords
adherence, new oral anticoagulants (NOACs), AF
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).
Interventions
None listed
Sponsors
National Research Center for Preventive Medicine
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) | 6 months | 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. |
| Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Main Reasons for Refusing to Start NOAC Therapy | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) | 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. |
| Proportion of Potentially Adherent Patients | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) | 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. |
| Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) | 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. |
| Reasons for Stopping Oral Anticoagulants (Data From Visit 1) | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)) | 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). |
| Proportion of OACs Prescribed by Doctors According to Guidelines | Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC) | 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. |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ANTEY Patients with AF from the PROFILE registry were included. 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 all visits with the use of the original questionnaire - National society of evidence-based pharmacotherapy (NSEPh) adherence scale and direct doctors' questioning. | 201 |
| Total | 201 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 1 |
Baseline characteristics
| Characteristic | ANTEY |
|---|---|
| Age, Continuous | 71.1 years STANDARD_DEVIATION 8.7 |
| NOAC recommended to patients by doctors during V0 apixaban | 43 Participants |
| NOAC recommended to patients by doctors during V0 dabigatran | 47 Participants |
| NOAC recommended to patients by doctors during V0 rivaroxaban | 111 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 201 Participants |
| Region of Enrollment Russia | 201 Participants |
| Sex: Female, Male Female | 83 Participants |
| Sex: Female, Male Male | 118 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 4 / 201 |
| other Total, other adverse events | 30 / 201 |
| serious Total, serious adverse events | 21 / 201 |
Outcome results
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.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) | completely adherent | 158 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) | partially adherent | 6 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) | partially non-adherent | 18 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) | completely non-adherent | 15 Participants |
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.
Time frame: 6 months
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) | completely adherent | 155 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) | partially adherent | 5 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) | partially non-adherent | 7 Participants |
| ANTEY | Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) | completely non-adherent | 33 Participants |
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. 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)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Proportion of OACs Prescribed by Doctors According to Guidelines | OACs were recommended by doctors | 171 Participants |
| ANTEY | Proportion of OACs Prescribed by Doctors According to Guidelines | OACs were not recommended by doctors | 30 Participants |
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Proportion of Potentially Adherent Patients | completely adherent | 161 Participants |
| ANTEY | Proportion of Potentially Adherent Patients | partially adherent | 28 Participants |
| ANTEY | Proportion of Potentially Adherent Patients | completely non-adherent | 12 Participants |
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) | others | 3 Participants |
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) | bleeding | 7 Participants |
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) | cancellation by another doctor | 6 Participants |
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) | high cost | 2 Participants |
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).
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From Visit 1) | bleeding | 5 Participants |
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From Visit 1) | cancellation by another doctor | 1 Participants |
| ANTEY | Reasons for Stopping Oral Anticoagulants (Data From Visit 1) | high cost | 1 Participants |
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.
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | adherence to another NOAC | 2 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | high price of NOAC | 14 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | fear of adverse events | 6 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | doubts about the correctness of prescribtion | 5 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | adherence to Warfarin | 2 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | difficult regimen for all drugs | 2 Participants |
| ANTEY | The Main Reasons for Refusing to Start NOAC Therapy | lack of NOAC in the preferential drug list | 2 Participants |