Atrial FibrillationPOL-AFNCT04419012
Polish Atrial Fibrillation (POL-AF) Registry
An observational study of Atrial Fibrillation, run by Jan Kochanowski University at 1 site in Poland.
Trial summary
Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- What is being tested?
- observation
- How many people
- 4,000 participants
- Where
- 1 sitePoland
- Study dates
- 6 Jan 2019to 31 Dec 2020
- How long will I take part?
- 1 Year
- 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: All patients with AF hospitalized in a participating center during study period.
Who may be able to join
- patients with AF hospitalized in a participating center during study period
Who cannot join
- hospitalisation for atrial fibrillation ablation
- death during hospitalization
Trial locations and contacts
1 site in 1 country.
About this study
Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).
Read the detailed description
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular mortality. An important element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.
Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.
Secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients and assesment of the number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc score.
The POL-AF Registry is a multicenter prospective analysis of hospital records of patients with AF managed in ten cardiology centers.
Collected data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications.
Each patient will be evaluated regarding to common scales assessing risk of thromboembolic (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events.
- Conditions
- Atrial Fibrillation
- Being tested
- observation
- Keywords
- Atrial fibrillation, anticoagulant treatment, apixaban, dabigatran, rivaroxaban, vitamin K antagonist, stroke prevention
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
observation
| Study group | Role | What they receive |
|---|---|---|
| Patients with AF treated with VKA | Not described Receives: Other: observation | |
| Patients with AF treated with NOAC | Not described Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.
Compared data will include: frequency of VKAs vs NOACs prescriptions.
Measured: Through the study completion, an average of 2 months.
Secondary outcomes (2)
Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.
Compared data will include: demographics, type of AF, medical history, baseline characteristics and concomitant medications.
Measured: Through the study completion, an average of 2 months.
Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.
The CHA2DS2-VAS score includes the following factors: heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex.
According to the CHA2DS2-VAS score, high thromboembolic risk means 2 points in men, 3 points in women.
Data on the components of CHA2DS2-VASC are obtained from medical records.
Measured: Through the study completion, an average of 2 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start6 Jan 2019
- Primary completion30 Jun 2020
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 4,000 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Jan Kochanowski University
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Warsaw
- Responsible party
- Principal investigator, Iwona Gorczyca, Jan Kochanowski University
- Investigators
- Iwona Gorczyca, Md,PhD, Principal investigator, Collegium Medicum, Jan Kochanowski University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04419012
- Sponsor's protocol ID
- 104/018
- Acronym
- POL-AF
- Status last verified
- Jul 2020
- First submitted
- 13 May 2020
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Uzieblo-Zyczkowska B, Krzesinski P, Maciorowska M, Gorczyca I, Jelonek O, Wojcik M, Blaszczyk R, Kaplon-Cieslicka A, Gawalko M, Tokarek T, Rajtar-Salwa R, Bil J, Wojewodzki M, Szpotowicz A, Krzciuk M, Bednarski J, Bakula-Ostalska E, Tomaszuk-Kazberuk A, Szyszkowska A, Welnicki M, Mamcarz A, Wozakowska-Kaplon B. Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, including compliance with current guidelines-data from the POLish Atrial Fibrillation (POL-AF) Registry. Cardiovasc Diagn Ther. 2021 Feb;11(1):14-27. doi: 10.21037/cdt-20-839.
PubMed 33708474
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polish Atrial Fibrillation (POL-AF) Registry
- ClinicalTrials.gov ID
- NCT04419012
- Acronym / sponsor ID
- POL-AF / 104/018
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial fibrillation, anticoagulant treatment, apixaban, dabigatran, rivaroxaban, vitamin K antagonist, stroke prevention
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 4,000 participants (estimated)
- Lead sponsor
- Jan Kochanowski UniversityUniversity, hospital or other
- Collaborators
- Medical University of Warsaw
- Study start
- 6 Jan 2019 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Jun 2020 (actual)
- 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.
Evaluation of clinical characteristics and pharmacotherapy of hospitalized Polish patients with atrial fibrillation (AF).
Detailed description
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular mortality. An important element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants (NOACs) and vitamin K antagonists (VKAs) are two main drugs groups used in thromboembolic events prevention.
Primary objective of the study is to assess the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.
Secondary objective of the study are as follows: assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients and assesment of the number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc score.
The POL-AF Registry is a multicenter prospective analysis of hospital records of patients with AF managed in ten cardiology centers.
Collected data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, laboratory tests, echocardiographic parameters and concomitant medications.
Each patient will be evaluated regarding to common scales assessing risk of thromboembolic (CHA2DS2-VASc) and bleeding (HAS-BLED, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with AF treated with VKA | – | Other: observation |
| Patients with AF treated with NOAC | – | Other: observation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with AF hospitalized in a participating center during study period.
Key inclusion criteria (1 listed)
- patients with AF hospitalized in a participating center during study period
Key exclusion criteria (2 listed)
- hospitalisation for atrial fibrillation ablation
- death during hospitalization
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 |
|---|---|---|
| observationobservation | Other | Patients with AF treated with NOAC, Patients with AF treated with VKA |
Primary outcome
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs.
Time frame: Through the study completion, an average of 2 months.
Compared data will include: frequency of VKAs vs NOACs prescriptions.
2 secondary outcomes
Assessment of the frequency of appropriate/inappropriate OACs prescription in AF patients.
Time frame: Through the study completion, an average of 2 months.
Number of patients with AF treated with apixaban, dabigatran and rivaroxaban with high thromboembolism risk according to CHA2DS2-VASc (heart failure, hypertension, age, diabetes mellitus, stroke/TIA/thromboembolism, vascular disease and sex) score.
Time frame: Through the study completion, an average of 2 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- Derived from this study: PubMed 33708474Uzieblo-Zyczkowska B, Krzesinski P, Maciorowska M, Gorczyca I, Jelonek O, Wojcik M, Blaszczyk R, Kaplon-Cieslicka A, Gawalko M, Tokarek T, Rajtar-Salwa R, Bil J, Wojewodzki M, Szpotowicz A, Krzciuk M, Bednarski J, Bakula-Ostalska E, Tomaszuk-Kazberuk A, Szyszkowska A, Welnicki M, Mamcarz A, Wozakowska-Kaplon B. Antithrombotic therapy in patients with atrial fibrillation undergoing percutaneous coronary intervention, including compliance with current guidelines-data from the POLish Atrial Fibrillation (POL-AF) Registry. Cardiovasc Diagn Ther. 2021 Feb;11(1):14-27. doi: 10.21037/cdt-20-839.
- Individual participant dataSharing planned: Undecided
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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.
Iwona Gorczyca, Md,PhD principal investigator
Collegium Medicum, Jan Kochanowski University
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 Atrial Fibrillation, run by Jan Kochanowski University at 1 site in Poland.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. 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 Poland. 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?
Results are not available in the source record.
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?
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs. (time frame: Through the study completion, an average of 2 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04419012, which also lists 1 linked publication.
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 29 Jul 2020.