Atrial FibrillationCRAFTNCT02987062
MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)
An observational study of Atrial Fibrillation, run by Medical University of Warsaw at 2 sites in Poland.
Trial summary
According to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atrial Fibrillation
- How many people
- 2,000 participants
- Where
- 2 sitesPoland
- Study dates
- Nov 2016to Sep 2017
- 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: The study will include patients with AF treated with VKAs (acenocoumarol, warfarin) and NOACs (apixaban, dabigatran, riwaroxaban), hospitalized in 2011-2016 years in the First Department of Cardiology of Medical University of Warsaw and hospitalized in 2014-2016 in the John Paul II Western Hospital in Grodzisk Mazowiecki, Poland.
Who may be able to join
- paroxysmal, persistent, long-standing persistent or permanent AF
- valvular or non-valvular AF
- treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)
Who cannot join
- lack of OAC at hospital discharge
Trial locations and contacts
2 sites in 1 country.
Poland2 sites, 2 recruiting
- Recruiting
John Paul II Western Hospital
Grodzisk Mazowiecki, 05-825
Janusz Bednarski, PhD
Janusz Bednarski, PhD
- Recruiting
1st Department of Cardiology Medical University of Warsaw
Warsaw, Mazowiecki, 02-097
Paweł Balsam, PhD, 605 152 120 ext. 0048, pawel.balsam@me.com
Krzysztof Ozierański, MD, 509 996 947 ext. 0048, krzysztof.ozieranski@gmail.com
About this study
Official title: CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)
According to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on real-life clinical practice.
The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs) in an academic and district hospital, with regard to inclusion/exclusion criteria used in the clinical trials.
Read the detailed description
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular morbidity and mortality. An integral element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and vitamin K antagonists are two main drugs groups used in treatment.
Primary objective of the study is to assess the treatment of AF patients with OACs (the frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) and population gathered from the university department and the district hospital. Secondary objective of the study is to assess the long-term outcomes of patients with AF treated with OACs.
The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter retrospective analysis of hospital records of patients with AF managed in the First Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics (i.e. blood pressure), laboratory investigations (blood tests, including renal and hepatic function), echocardiographic parameters and concomitant medications. Data will be collected from the moment of patient's discharge.
Each patient will be evaluated regarding to common and new scales assessing risk of thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of treatment on OACs.
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Non-vitamin K Oral Anticoagulants, Vitamin K Antagonists, ROCKET-AF, RE-LY, ARISTOTLE
- Medical subject headings
- Atrial Fibrillation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Acenocoumarol | Patients with AF treated with acenocoumarol. | |
| Warfarin | Patients with AF treated with warfarin. | |
| Apixaban | Patients with AF treated with apixaban. | |
| Dabigatran | Patients with AF treated with dabigatran. | |
| Rivaroxaban | Patients with AF treated with rivaroxaban. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)
Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
Measured: Through the study completion, an average of 3 months.
Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital
Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
Measured: Through the study completion, an average of 3 months.
Secondary outcomes (2)
Assessment of the frequency of VKAs vs NOACs prescription in AF patients treatment of with OACs
Measured: Through the study completion, an average of 3 months.
Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)
Measured: Through the study completion, an average of 3 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Atrial FibrillationStudies of the same condition, open and under way.
- More trials run by Medical University of WarsawThe 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
- Retrospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medical University of Warsaw
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcin Grabowski, Medical University of Warsaw
- Investigators
- Grzegorz Opolski, Professor, Study chair, 1st Department of Cardiology Medical University of WarsawMarcin Grabowski, PhD, Study chair, 1st Department of Cardiology Medical University of Warsaw
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02987062
- Sponsor's protocol ID
- CRAFT
- Acronym
- CRAFT
- Status last verified
- Jun 2017
- First submitted
- 30 Nov 2016
- Last updated
- 8 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Maciejewski C, Ozieranski K, Basza M, Barwiolek A, Ciurla M, Bozym A, Krajsman MJ, Lodzinski P, Opolski G, Grabowski M, Cacko A, Balsam P. Practical use case of natural language processing for observational clinical research data retrieval from electronic health records: AssistMED project. Pol Arch Intern Med. 2024 May 28;134(5):16704. doi: 10.20452/pamw.16704. Epub 2024 Mar 19.
PubMed 38501989Maciejewski C, Ozieranski K, Basza M, Lodzinski P, Sliwczynski A, Kraj L, Krajsman MJ, Prado Paulino J, Tyminska A, Opolski G, Cacko A, Grabowski M, Balsam P. Administrative Data in Cardiovascular Research-A Comparison of Polish National Health Fund and CRAFT Registry Data. Int J Environ Res Public Health. 2022 Sep 22;19(19):11964. doi: 10.3390/ijerph191911964.
PubMed 36231265Balsam P, Tyminska A, Ozieranski K, Zaleska M, Zukowska K, Szepietowska K, Maciejewski K, Peller M, Grabowski M, Lodzinski P, Koltowski L, Praska-Oginska A, Zaboyska I, Bednarski J, Filipiak KJ, Opolski G. Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients? Cardiol J. 2020;27(5):590-599. doi: 10.5603/CJ.a2018.0135. Epub 2018 Nov 8.
PubMed 30406937
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CRAFT - Multicenter Experience in Atrial Fibrillation Patients Treated With OAC (CRAFT)
- ClinicalTrials.gov ID
- NCT02987062
- Acronym / sponsor ID
- CRAFT / CRAFT
- Conditions
- Atrial Fibrillation
- Keywords
- Atrial Fibrillation, Non-vitamin K Oral Anticoagulants, Vitamin K Antagonists, ROCKET-AF, RE-LY, ARISTOTLE
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Medical University of WarsawUniversity, hospital or other
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 8 Dec 2016 (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.
According to current guidelines for non-valvular atrial fibrillation treatment, the first line drugs are non-vitamin K oral anticoagulants (NOACs), which are preferred over vitamin K antagonists (VKAs). However, it is not clearly confirmed, how the success of NOACs approval trials (ROCKET-AF (rivaroxaban), RE-LY (dabigatran) and ARISTOTLE (apixaban) reflects on real-life clinical practice.
The aim of this study is to assess treatment of AF patients with oral anticoagulants (OACs) in an academic and district hospital, with regard to inclusion/exclusion criteria used in the clinical trials.
Detailed description
Atrial fibrillation (AF) is a common arrhythmia associated with increased cardiovascular morbidity and mortality. An integral element of management of patients with AF is anticoagulation to prevent thromboembolic events. Non-vitamin K oral anticoagulants and vitamin K antagonists are two main drugs groups used in treatment.
Primary objective of the study is to assess the treatment of AF patients with OACs (the frequency of prescription of VKAs vs NOACs), compare the clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) and population gathered from the university department and the district hospital. Secondary objective of the study is to assess the long-term outcomes of patients with AF treated with OACs.
The CRAFT (MultiCenter expeRience in AFib patients Treated with OAC) is a multicenter retrospective analysis of hospital records of patients with AF managed in the First Department of Cardiology of Medical University of Warsaw and in John Paul II Western Hospital in Grodzisk Mazowiecki. Gathered data will include demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics (i.e. blood pressure), laboratory investigations (blood tests, including renal and hepatic function), echocardiographic parameters and concomitant medications. Data will be collected from the moment of patient's discharge.
Each patient will be evaluated regarding to common and new scales assessing risk of thromboembolic (CHA2DS2-VASc ) and bleeding (HAS-BLED, HEMORR2HAGES, modifiable and non-modifiable risk factors for bleeding in anticoagulated patients basing on the current guidelines for AF treatment) events, as well as SAMeTT2R2 score to predict the quality of treatment on OACs.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Acenocoumarol | – | –Patients with AF treated with acenocoumarol. |
| Warfarin | – | –Patients with AF treated with warfarin. |
| Apixaban | – | –Patients with AF treated with apixaban. |
| Dabigatran | – | –Patients with AF treated with dabigatran. |
| Rivaroxaban | – | –Patients with AF treated with rivaroxaban. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will include patients with AF treated with VKAs (acenocoumarol, warfarin) and NOACs (apixaban, dabigatran, riwaroxaban), hospitalized in 2011-2016 years in the First Department of Cardiology of Medical University of Warsaw and hospitalized in 2014-2016 in the John Paul II Western Hospital in Grodzisk Mazowiecki, Poland.
Key inclusion criteria (3 listed)
- paroxysmal, persistent, long-standing persistent or permanent AF
- valvular or non-valvular AF
- treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)
Key exclusion criteria (1 listed)
- lack of OAC at hospital discharge
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE)
Time frame: Through the study completion, an average of 3 months.
Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
Comparison of clinical characteristics of the AF patients treated in university department with population gathered from the district hospital
Time frame: Through the study completion, an average of 3 months.
Compared data will include: demographics, type of AF (valvular and non-valvular, as well as paroxysmal, persistent and permanent), medical history, baseline characteristics, laboratory investigations, echocardiographic parameters and concomitant medications. Each patient will be evaluated regarding to the modifiable and non-modifiable risk factors for bleeding basing on the current guidelines for AF treatment, CHA2DS2-VASc, HAS-BLED, HEMORR2HAGES scales and SAMeTT2R2 score.
2 secondary outcomes
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 3 months.
Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)
Time frame: Through the study completion, an average of 3 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
- Derived from this study: PubMed 38501989Maciejewski C, Ozieranski K, Basza M, Barwiolek A, Ciurla M, Bozym A, Krajsman MJ, Lodzinski P, Opolski G, Grabowski M, Cacko A, Balsam P. Practical use case of natural language processing for observational clinical research data retrieval from electronic health records: AssistMED project. Pol Arch Intern Med. 2024 May 28;134(5):16704. doi: 10.20452/pamw.16704. Epub 2024 Mar 19.
- Derived from this study: PubMed 36231265Maciejewski C, Ozieranski K, Basza M, Lodzinski P, Sliwczynski A, Kraj L, Krajsman MJ, Prado Paulino J, Tyminska A, Opolski G, Cacko A, Grabowski M, Balsam P. Administrative Data in Cardiovascular Research-A Comparison of Polish National Health Fund and CRAFT Registry Data. Int J Environ Res Public Health. 2022 Sep 22;19(19):11964. doi: 10.3390/ijerph191911964.
- Derived from this study: PubMed 30406937Balsam P, Tyminska A, Ozieranski K, Zaleska M, Zukowska K, Szepietowska K, Maciejewski K, Peller M, Grabowski M, Lodzinski P, Koltowski L, Praska-Oginska A, Zaboyska I, Bednarski J, Filipiak KJ, Opolski G. Randomized controlled clinical trials versus real-life atrial fibrillation patients treated with oral anticoagulants. Do we treat the same patients? Cardiol J. 2020;27(5):590-599. doi: 10.5603/CJ.a2018.0135. Epub 2018 Nov 8.
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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.
Grzegorz Opolski, Professor study chair
1st Department of Cardiology Medical University of Warsaw
Marcin Grabowski, PhD study chair
1st Department of Cardiology Medical University of Warsaw
2 sites 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 Medical University of Warsaw at 2 sites 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 3 inclusion and 1 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Contact Paweł Balsam, PhD (605 152 120 ext. 0048, pawel.balsam@me.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of clinical characteristics of the real-life AF patients with populations included in the randomized clinical trials (ROCKET-AF, RE-LY and ARISTOTLE) (time frame: Through the study completion, an average of 3 months.). The study lists 2 primary outcomes in all. 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 NCT02987062, which also lists 3 linked publications.
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 8 Jun 2017.