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

Completed

• Conditions: Prevention and Control; Stroke; Atrial Fibrillation
• Interventions: Drug: Direct Oral Anticoagulant (DOAC)

• Registration Number: NCT02559232
• Lead Sponsor: Bayer

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2015-09-17
• Study First Submitted QC: 2015-09-23
• Study First Posted: 2015-09-24
• Primary Completion: 2015-12
• Study Completion: 2016-03
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-15
• Last Update Posted: 2017-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 247

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.

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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 .

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
DOAC treated patients	Direct Oral Anticoagulant (DOAC)	Patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres with DOAC.

Primary Outcome Measures

Name	Time	Method
Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia	At baseline visit	clinical characteristics
Age	At baseline visit	sociodemographic data
Race	At baseline visit	sociodemographic data
Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	At baseline visit	clinical characteristics
Risk of thromboembolic event based on the CHADS2 score	At baseline visit	clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding	At baseline visit	sociodemographic data
Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	At baseline visit	clinical characteristics
Concomitant treatments: therapy group of relevant active substances	At baseline visit	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
Risk of bleeding based on the HAS-BLED score	At baseline visit	clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly
Gender	At baseline visit	sociodemographic data
Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances	At baseline visit	clinical characteristics
Risk of thromboembolic event based on the CHA2DS2-VASc score	At baseline visit	clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category

Secondary Outcome Measures

Name	Time	Method
Adherence to treatment	At baseline visit	use of Haynes-Sackett test
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.	At baseline visit	Healthcare resources
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	At baseline visit	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.