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 (BRONCE-AP)

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

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)

Study Overview

• Status: Completed
• Conditions: Stroke; Atrial Fibrillation; Prevention and Control
• Intervention / Treatment: Drug: Direct Oral Anticoagulant (DOAC)

• Study Type: Observational
• Enrollment (Actual): 247

Contacts and Locations

Study Locations

• Spain
  • Many Locations, Spain

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 .

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
DOAC treated patients; Patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres with DOAC.	Drug: Direct Oral Anticoagulant (DOAC); Treatment pattern following the summary of product characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age	sociodemographic data	At baseline visit
Gender	sociodemographic data	At baseline visit
Race	sociodemographic data	At baseline visit
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding	sociodemographic data	At baseline visit
Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia	clinical characteristics	At baseline visit
Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Concomitant treatments: therapy group of relevant active substances	clinical characteristics; therapy group of relevant active substances: antiarrhythmics, Angiotensin-converting enzyme inhibitors, angiotensin II receptor blockers, β-blockers, dihydropyridine calcium channel blockers, diuretics, hypolipemiant drugs, oral anti-diabetics and human insulin, antiplatelet agents, nonsteroidal anti-inflammatory drugs, Proton-pump inhibitors, others: specify	At baseline visit
Risk of thromboembolic event based on the CHADS2 score	clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke	At baseline visit
Risk of thromboembolic event based on the CHA2DS2-VASc score	clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category	At baseline visit
Risk of bleeding based on the HAS-BLED score	clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly	At baseline visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adherence to treatment	use of Haynes-Sackett test	At baseline visit
Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire		At baseline visit
Compliance with the criteria in therapeutic positioning report UT/V4/23122013	In some Spanish regions it is mandatory to accomplish the conditions of the national guideline UT/V4/23122013 regarding the use of direct oral anticoagulant. In that guideline the characteristics of patients candidates to direct oral anticoagulant are explained.	At baseline visit
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.	Healthcare resources	At baseline visit

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: September 17, 2015
• First Submitted That Met QC Criteria: September 23, 2015
• First Posted (Estimate): September 24, 2015

Study Record Updates

• Last Update Posted (Actual): February 16, 2017
• Last Update Submitted That Met QC Criteria: February 15, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Embolism and Thrombosis; Arrhythmias, Cardiac; Stroke; Embolism; Atrial Fibrillation; Anticoagulants
• Other Study ID Numbers: 17961