Clinical trial NCT02470767: An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres
Official title: An Observational Cross-sectional Study Evaluating the Sociodemographic and Clinical Characteristics of Patients Diagnosed With NVAF With a Risk of Stroke or Systemic Embolism, Who Are on Treatment to Adequately Control Their Coagulation and Treated in Primary Care Centres
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Prevention and Control
Atrial Fibrillation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2015-06-12
Enrollment: 792
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: describe the sociodemographic and clinical characteristics of patients diagnosed with non-valvular atrial fibrillation (NVAF) at risk of stroke or systemic embolism on anticoagulant therapy who have changed their therapeutic regimen, due to any clinical situation, based on the doctor's routine clinical practice and are currently on treatment with a direct oral anticoagulant (DOAC)


Eligibility criteria: Inclusion Criteria:

* Patients ≥18 years of age diagnosed with NVAF with a risk of stroke or systemic embolism treated in primary care centres.
* Patients on regular treatment with anticoagulants who have changed their ther-apeutic regimen due to any clinical situation and have been on treatment with a DOAC for at least three months before being recruited (date of signing the in-formed consent).
* Patients whose DOAC has been indicated by the primary care physician.
* 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 NVAF with a DOAC.

Primary outcomes:
measure: Composite of demographic characteristics: age, gender and race
timeFrame: At baseline visit
measure: Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
timeFrame: At baseline visit
measure: Composite of comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia,
timeFrame: At baseline visit
measure: Data on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
timeFrame: At baseline visit
measure: Concomitant treatments: 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
timeFrame: At baseline visit
measure: Reason of the change in treatment: according to Spanish guideline for the SPAF management: IPT (Informe de Posicionamiento Terapeutico)
timeFrame: At baseline visit
Other outcomes:
Locations:
city: Many Locations
country: Spain
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: