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

30 juni 2020 bijgewerkt door: National Research Center for Preventive Medicine

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).

  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)

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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).

Studietype

Observationeel

Inschrijving (Werkelijk)

201

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Russische Federatie
      • Moscow, Russische Federatie, 101990
        • National Research Center for Preventive Medicine

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Observatiemodellen: Cohort
  • Tijdsperspectieven: Prospectief

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
Tijdsspanne: 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
Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
Tijdsspanne: 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

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Proportion of Potentially Adherent Patients
Tijdsspanne: 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.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Proportion of OACs Prescribed by Doctors According to Guidelines
Tijdsspanne: 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.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
The Main Reasons for Refusing to Start NOAC Therapy
Tijdsspanne: 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.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
Tijdsspanne: 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).
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
Tijdsspanne: 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.
Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

National Research Center for Preventive Medicine

Onderzoekers

  • Hoofdonderzoeker: Sergey Martsevich, MD,PhD, National Research Center of Preventive Medicine

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

5 september 2017

Primaire voltooiing (Werkelijk)

28 december 2018

Studie voltooiing (Werkelijk)

28 december 2018

Studieregistratiedata

Eerst ingediend

28 december 2018

Eerst ingediend dat voldeed aan de QC-criteria

29 december 2018

Eerst geplaatst (Werkelijk)

2 januari 2019

Updates van studierecords

Laatste update geplaatst (Werkelijk)

16 juli 2020

Laatste update ingediend die voldeed aan QC-criteria

30 juni 2020

Laatst geverifieerd

1 mei 2020

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • ANTEY

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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