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

Stroke Clinical Trial

— BRONCE-AP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02559232
• Other study ID #: 17961
• Status: Completed
• Phase: N/A
• First received: September 17, 2015
• Last updated: February 15, 2017
• Start date: September 2015
• Est. completion date: March 2016

Study information

• Verified date: February 2017
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 247
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Atrial Fibrillation
• Embolism
• Prevention and Control
• Stroke

Intervention

Drug:
• Direct Oral Anticoagulant (DOAC)
Treatment pattern following the summary of product characteristics

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Age	sociodemographic data	At baseline visit
Primary	Gender	sociodemographic data	At baseline visit
Primary	Race	sociodemographic data	At baseline visit
Primary	Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding	sociodemographic data	At baseline visit
Primary	Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia	clinical characteristics	At baseline visit
Primary	Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Primary	Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Primary	Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	clinical characteristics	At baseline visit
Primary	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, ß-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
Primary	Risk of thromboembolic event based on the CHADS2 score	clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke	At baseline visit
Primary	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
Primary	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	Adherence to treatment	use of Haynes-Sackett test	At baseline visit
Secondary	Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire		At baseline visit
Secondary	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
Secondary	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

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