Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY (ANTEY)
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).
- 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)
Přehled studie
Postavení
Podmínky
Detailní popis
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).
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
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Moscow, Ruská Federace, 101990
- National Research Center for Preventive Medicine
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Observační modely: Kohorta
- Časové perspektivy: Budoucí
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
Časové okno: 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. |
6 months
|
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Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
Časové okno: 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. |
1 year
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of Potentially Adherent Patients
Časové okno: 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.
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Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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Proportion of OACs Prescribed by Doctors According to Guidelines
Časové okno: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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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.
|
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
|
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The Main Reasons for Refusing to Start NOAC Therapy
Časové okno: 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.
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Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
Časové okno: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
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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).
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Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
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Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
Časové okno: 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.
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Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Sergey Martsevich, MD,PhD, National Research Center of Preventive Medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- ANTEY
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