Clinical trial NCT02559232: An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With Non-valvular Atrial Fibrillation With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers
Official title: An Observational Cross-sectional Study Evaluating the Use of Re-sources and the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism on Anticoagulant Therapy and Treated in Primary Care Centers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Prevention and Control
Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-09-24
Enrollment: 247
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients at risk of stroke or systemic embolism on anticoagulant therapy, who have changed their therapeutic regimen according to their doctor's decision, due to any clinical situation and based on routine clinical practice, and who at the time of enrolment in the study have been receiving treatment with a DOAC for at least three months

Brief summary: This is a retrospective observational study to describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism, who at least three months ago changed their anticoagulant therapy, due to any clinical situation, and are currently on treatment with a direct oral anticoagulant (DOAC)


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age diagnosed with non-valvular atrial fibrillation with a risk of stroke or systemic embolism treated in primary care centres.
* Patients on regular treatment with anticoagulants who have changed their therapeutic regimen due to any clinical situation and have been on treatment with a direct oral anticoagulant for at least three months before being recruited (date of signing the in-formed consent).
* Patients whose first direct oral anticoagulant prescription is written by the specialist (cardiologist, haematologist, internist, etc.) and who are followed in primary care.
* Patients who have given their informed consent in writing.

Exclusion Criteria:

* Patients who changed their anticoagulant therapy within a period of less than three months before signing the informed consent.
* Patients with cognitive impairment preventing them from understanding what is written in the patient information sheet or the informed consent, or from per-forming the self-administered questionnaires.
* Patients who started anticoagulant therapy for non-valvular atrial fibrillation with a direct oral anticoagulant .

Primary outcomes:
measure: Age
timeFrame: At baseline visit
measure: Gender
timeFrame: At baseline visit
measure: Race
timeFrame: At baseline visit
measure: Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
timeFrame: At baseline visit
measure: Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
timeFrame: At baseline visit
measure: Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
timeFrame: At baseline visit
measure: Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
timeFrame: At baseline visit
measure: Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
timeFrame: At baseline visit
measure: Concomitant treatments: therapy group of relevant active substances
timeFrame: At baseline visit
measure: Risk of thromboembolic event based on the CHADS2 score
timeFrame: At baseline visit
measure: Risk of thromboembolic event based on the CHA2DS2-VASc score
timeFrame: At baseline visit
measure: Risk of bleeding based on the HAS-BLED score
timeFrame: At baseline visit
Secondary outcomes:
measure: Adherence to treatment
timeFrame: At baseline visit
measure: Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire
timeFrame: At baseline visit
measure: Compliance with the criteria in therapeutic positioning report UT/V4/23122013
timeFrame: At baseline visit
measure: Use of healthcare resources: Number of visits with primary care physician. Number of visits with specialist, Number of visits with nursing staff, Number of visits to A&E, Number of diagnostic tests in the period when the change was made, related to NVAF.
timeFrame: At baseline visit
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: