Clinical trial NCT03790917: Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY
Official title: Assessment of Adherence to New Oral anTicoagulants in Atrial Fibrillation patiEnts Within the Outpatient registrY Profile. Prospective Observational Study. ANTEY Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: adherence
new oral anticoagulants (NOACs)
AF
Lead sponsor: National Medical Research Center for Therapy and Preventive Medicine
Sponsor class: OTHER_GOV
First posted: 2019-01-02
Enrollment: 201
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary patients with non-valvular atrial fibrillation included in the outpatient registry PROFILE during the period 01.01.2011-31.08.2015.

Brief 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 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)

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).

Eligibility criteria: 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

Primary outcomes:
measure: Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During V1)
timeFrame: 6 months
measure: Proportions of Adherent, Partially Adherent, Partially Non-adherent and Completely Non-adherent Patients (NSEPh During Phone Contact)
timeFrame: 1 year
Secondary outcomes:
measure: Proportion of Potentially Adherent Patients
timeFrame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
measure: Proportion of OACs Prescribed by Doctors According to Guidelines
timeFrame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
measure: The Main Reasons for Refusing to Start NOAC Therapy
timeFrame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
measure: Reasons for Stopping Oral Anticoagulants (Data From Visit 1)
timeFrame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC))
measure: Reasons for Stopping Oral Anticoagulants (Data From the Phone Contact)
timeFrame: Total - 1 year (two timepoints - 6 months (V1) and 1 year (PC)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: National Research Center for Preventive Medicine
Study officials:
affiliation: National Research Center of Preventive Medicine
name: Sergey Martsevich, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References: