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)
Visão geral do estudo
Status
Condições
Descrição detalhada
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).
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Moscow, Federação Russa, 101990
- National Research Center for Preventive Medicine
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
Prazo: 6 months
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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)
Prazo: 1 year
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of Potentially Adherent Patients
Prazo: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
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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
Prazo: 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.
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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
Prazo: 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)
Prazo: 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)
Prazo: 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 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Sergey Martsevich, MD,PhD, National Research Center of Preventive Medicine
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- ANTEY
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