Trial Condition(s):
Stroke, prevention and control, Atrial Fibrillation
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)
Bayer Identifier:
17961
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Trial Purpose
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)
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 .
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site many locations, Spain | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
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
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Agesociodemographic dataTimeframe: At baseline visit
- Gendersociodemographic dataTimeframe: At baseline visit
- Racesociodemographic dataTimeframe: At baseline visit
- Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleedingsociodemographic dataTimeframe: At baseline visit
- Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemiaclinical characteristicsTimeframe: At baseline visit
- Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substancesclinical characteristicsTimeframe: At baseline visit
- Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substancesclinical characteristicsTimeframe: At baseline visit
- Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substancesclinical characteristicsTimeframe: At baseline visit
- Concomitant treatments: therapy group of relevant active substancesclinical 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: specifyTimeframe: At baseline visit
- Risk of thromboembolic event based on the CHADS2 scoreclinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, StrokeTimeframe: At baseline visit
- Risk of thromboembolic event based on the CHA2DS2-VASc scoreclinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex categoryTimeframe: At baseline visit
- Risk of bleeding based on the HAS-BLED scoreclinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantlyTimeframe: At baseline visit
Secondary Outcome
- Adherence to treatmentuse of Haynes–Sackett testTimeframe: At baseline visit
- Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaireTimeframe: At baseline visit
- Compliance with the criteria in therapeutic positioning report UT/V4/23122013In 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.Timeframe: 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 resourcesTimeframe: At baseline visit
Additional Information
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