Trial Outcomes & Findings for Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY (NCT NCT03790917)

NCT ID: NCT03790917

Last Updated: 2020-07-16

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 201 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2020-07-16

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	201
Overall Study COMPLETED	200
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

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.

Overall Study Death

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	ANTEY n=201 Participants 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.
Age, Continuous	71.1 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	83 Participants n=5 Participants
Sex: Female, Male Male	118 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	201 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Russia	201 Participants n=5 Participants
NOAC recommended to patients by doctors during V0 rivaroxaban	111 Participants n=5 Participants
NOAC recommended to patients by doctors during V0 dabigatran	47 Participants n=5 Participants
NOAC recommended to patients by doctors during V0 apixaban	43 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=200 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) completely adherent	155 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) partially adherent	5 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) partially non-adherent	7 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) completely non-adherent	33 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=197 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) completely adherent	158 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) partially adherent	6 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) partially non-adherent	18 Participants
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact) completely non-adherent	15 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=201 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Proportion of Potentially Adherent Patients completely adherent	161 Participants
Proportion of Potentially Adherent Patients partially adherent	28 Participants
Proportion of Potentially Adherent Patients completely non-adherent	12 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=201 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Proportion of OACs Prescribed by Doctors According to Guidelines OACs were recommended by doctors	171 Participants
Proportion of OACs Prescribed by Doctors According to Guidelines OACs were not recommended by doctors	30 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=33 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
The Main Reasons for Refusing to Start NOAC Therapy high price of NOAC	14 Participants
The Main Reasons for Refusing to Start NOAC Therapy fear of adverse events	6 Participants
The Main Reasons for Refusing to Start NOAC Therapy doubts about the correctness of prescribtion	5 Participants
The Main Reasons for Refusing to Start NOAC Therapy adherence to Warfarin	2 Participants
The Main Reasons for Refusing to Start NOAC Therapy adherence to another NOAC	2 Participants
The Main Reasons for Refusing to Start NOAC Therapy difficult regimen for all drugs	2 Participants
The Main Reasons for Refusing to Start NOAC Therapy lack of NOAC in the preferential drug list	2 Participants

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	ANTEY n=7 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Reasons for Stopping Oral Anticoagulants (Data From Visit 1) cancellation by another doctor	1 Participants
Reasons for Stopping Oral Anticoagulants (Data From Visit 1) high cost	1 Participants
Reasons for Stopping Oral Anticoagulants (Data From Visit 1) bleeding	5 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	ANTEY n=18 Participants 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, 8-item Morisky Medical Adherence Scale (MMAS-8) and direct doctors' questioning.
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) bleeding	7 Participants
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) cancellation by another doctor	6 Participants
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) high cost	2 Participants
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact) others	3 Participants

Adverse Events

ANTEY

Serious events: 21 serious events

Other events: 30 other events

Deaths: 4 deaths

Serious adverse events

Measure	ANTEY n=201 participants at risk 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.
Cardiac disorders Acute myiocardial infarction	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Cardiac disorders Unstable angina pectoris	2.5% 5/201 • Number of events 5 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Cardiac disorders CHF decompensation	2.5% 5/201 • Number of events 5 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Sarcoma	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Cardiac disorders Paroxysm of atrial fibrillation	2.5% 5/201 • Number of events 5 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Nervous system disorders Stroke	1.00% 2/201 • Number of events 2 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Eye disorders Bleeding in the retina	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Blood and lymphatic system disorders Iron deficiency anaemia	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.

Other adverse events

Measure	ANTEY n=201 participants at risk 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.
General disorders Bleeding	9.0% 18/201 • Number of events 19 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Gastrointestinal disorders Nausea	2.0% 4/201 • Number of events 4 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Immune system disorders Urticaria	1.00% 2/201 • Number of events 2 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Gastrointestinal disorders Obstipation	1.00% 2/201 • Number of events 2 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Endocrine disorders Hypothyroidism	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Respiratory, thoracic and mediastinal disorders Cough	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Reproductive system and breast disorders Gynecomastia	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.
Cardiac disorders Arterial hypotension	0.50% 1/201 • Number of events 1 • 1 year All cause mortality - 4: 2 patients died of chronic diseases (heart failure, cancer), 1 patient had sudden cardiac death, and 1 patietnt died in an accident.

Additional Information

professor Sergey Yu. Martsevich

National Medical Research Center for Preventive Medicine

Phone: 89161643690

Email: sergeymartsevich@mail.ru

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place