StrokeBRONCE-APNCT02559232
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
An observational study of Stroke and Prevention and Control, run by Bayer at 1 site in Spain.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Prevention and Control, Atrial Fibrillation
- What is being tested?
- Direct Oral Anticoagulant (DOAC)
- Type of treatment
- Pill or oral medicine
- How many people
- 247 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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)
- Conditions
- Stroke, Prevention and Control, Atrial Fibrillation
- Being tested
- Direct Oral Anticoagulant (DOAC)
- Medical subject headings
- Stroke, Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct Oral Anticoagulant (DOAC)Drug
Treatment pattern following the summary of product characteristics
| Study group | Role | What they receive |
|---|---|---|
| DOAC treated patients | Patients diagnosed with Non-Valvular Atrial Fibrillation at risk of stroke or systemic embolism treated in primary care centres with DOAC. Receives: Drug: Direct Oral Anticoagulant (DOAC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Age
sociodemographic data
Measured: At baseline visit
Gender
sociodemographic data
Measured: At baseline visit
Race
sociodemographic data
Measured: At baseline visit
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
sociodemographic data
Measured: At baseline visit
Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
clinical characteristics
Measured: At baseline visit
Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
clinical characteristics
Measured: At baseline visit
Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
clinical characteristics
Measured: At baseline visit
Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
clinical characteristics
Measured: 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
Measured: At baseline visit
Risk of thromboembolic event based on the CHADS2 score
clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Measured: 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
Measured: 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
Measured: At baseline visit
Secondary outcomes (4)
Adherence to treatment
use of Haynes-Sackett test
Measured: At baseline visit
Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire
Measured: 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.
Measured: 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
Measured: At baseline visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionDec 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StrokeStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 247 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bayer Study Director, Study director, Bayer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02559232
- Sponsor's protocol ID
- 17961
- Acronym
- BRONCE-AP
- Status last verified
- Feb 2017
- First submitted
- 17 Sep 2015
- Last updated
- 16 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02559232
- Acronym / sponsor ID
- BRONCE-AP / 17961
- Conditions
- Stroke, Prevention and Control, Atrial Fibrillation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 247 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- Sep 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 24 Sep 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DOAC treated patients | – | Drug: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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 .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Direct Oral Anticoagulant (DOAC)Treatment pattern following the summary of product characteristics | Drug | DOAC treated patients |
Primary outcome
Age
Time frame: At baseline visit
sociodemographic data
Gender
Time frame: At baseline visit
sociodemographic data
Race
Time frame: At baseline visit
sociodemographic data
Composite of relevant cardiovascular events: stroke, TIA, systemic embolism, bleeding
Time frame: At baseline visit
sociodemographic data
Composite number of participants with comorbidities: hypertension, heart failure, diabetes mellitus, kidney failure, dyslipidemia
Time frame: At baseline visit
clinical characteristics
Dose on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
Time frame: At baseline visit
clinical characteristics
Frequency on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
Time frame: At baseline visit
clinical characteristics
Duration on the Non-Valvular Atrial Fibrillation treatment: relevant active substances
Time frame: At baseline visit
clinical characteristics
Concomitant treatments: therapy group of relevant active substances
Time frame: 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 thromboembolic event based on the CHADS2 score
Time frame: At baseline visit
clinical characteristics; CHADS2: Cardiac failure, Hypertension, Age, Diabetes, Stroke
Risk of thromboembolic event based on the CHA2DS2-VASc score
Time frame: At baseline visit
clinical characteristics; CHA2DS2-VASc:Cardiac failure, Hypertension, Age ≥75, Diabetes, Stroke -Vascular disease, Age and sex category
Risk of bleeding based on the HAS-BLED score
Time frame: At baseline visit
clinical characteristics; HAS-BLED: Hypertension, Abnormal renal/liver function, Stroke, Bleeding history or predisposition, Labile INR, Elderly , Drugs/alcohol concomitantly
4 secondary outcomes
Adherence to treatment
Time frame: At baseline visit
Satisfaction of treatment by the mean score on the ACTS (Anti Clot Treatment Scale) questionnaire
Time frame: At baseline visit
Compliance with the criteria in therapeutic positioning report UT/V4/23122013
Time frame: 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.
Time frame: At baseline visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bayer Study Director study director
Bayer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stroke and Prevention and Control, run by Bayer at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Age (time frame: At baseline visit). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2017.