Atrial FibrillationANTEYNCT03790917
Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 201 participants
- Where
- 1 siteRussia
- Study dates
- 5 Sep 2017to 28 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.
Who may be able to join
- 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
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study
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).
Read more
- Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
- Evaluation of actual patient adherence to OACs
Secondary Study Objective(s)
- Evaluation of potential patient adherence to OACs
- Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
- Validation of new original 5-item Questionnaire
- Evaluation of doctor's adherence to OAC prescription according to Guidelines (ESC). Management of atrial fibrillation,2016)
Read the 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).
- Conditions
- Atrial Fibrillation
- Keywords
- adherence, new oral anticoagulants (NOACs), AF
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year
Secondary outcomes (5)
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.
Measured: 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.
- 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2019
- Study start5 Sep 2017
- Primary completion28 Dec 2018
- Study completion28 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Research Center for Preventive Medicine
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Sergey Martsevich, MD,PhD, Principal investigator, National Research Center of Preventive Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03790917
- Sponsor's protocol ID
- ANTEY
- Acronym
- ANTEY
- Status last verified
- May 2020
- First submitted
- 28 Dec 2018
- Last updated
- 16 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study
- ClinicalTrials.gov ID
- NCT03790917
- Acronym / sponsor ID
- ANTEY / ANTEY
- Conditions
- Atrial Fibrillation
- Keywords
- adherence, new oral anticoagulants (NOACs), AF
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- National Research Center for Preventive MedicineOther government
- Study start
- 5 Sep 2017 (actual)
- Primary completion
- 28 Dec 2018 (actual)
- Study completion
- 28 Dec 2018 (actual)
- First posted
- 2 Jan 2019 (actual)
- Results
- Posted 9 Jun 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
- Data collection in patients with non-valvular atrial fibrillation requiring OAC treatment included in the registry
- Evaluation of actual patient adherence to OACs
Secondary Study Objective(s)
- Evaluation of potential patient adherence to OACs
- Determination of the most significant factors associated with adherence to OACs in patients with non-valvular AF
- Validation of new original 5-item Questionnaire
- 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (13 listed)
- Patients with high bleeding risk, including patients with:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
Time frame: 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)
Time frame: 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.
5 secondary outcomes
Proportion of Potentially Adherent Patients
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Proportion of OACs Prescribed by Doctors According to Guidelines
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The Main Reasons for Refusing to Start NOAC Therapy
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
Time frame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Atrial Fibrillation (AF)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergey Martsevich, MD,PhD principal investigator
National Research Center of Preventive Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Fibrillation, run by National Research Center for Preventive Medicine at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jun 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1) (time frame: 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2020.