- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02987062
MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT) (CRAFT)
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.
Study Overview
Status
Conditions
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 Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Krzysztof Ozierański, MD
- Phone Number: 0048 509 996 947
- Email: krzysztof.ozieranski@gmail.com
Study Contact Backup
- Name: Paweł Balsam, PhD
- Phone Number: 0048 605 152 120
- Email: pawel.balsam@me.com
Study Locations
-
-
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Grodzisk Mazowiecki, Poland, 05-825
- Recruiting
- John Paul II Western Hospital
-
Contact:
- Janusz Bednarski, PhD
-
Principal Investigator:
- Janusz Bednarski, PhD
-
-
Mazowiecki
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Warsaw, Mazowiecki, Poland, 02-097
- Recruiting
- 1st Department of Cardiology Medical University of Warsaw
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Sub-Investigator:
- Grzegorz Opolski, Professor
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Sub-Investigator:
- Agata Tymińska, MD
-
Contact:
- Krzysztof Ozierański, MD
- Phone Number: 0048 509 996 947
- Email: krzysztof.ozieranski@gmail.com
-
Contact:
- Paweł Balsam, PhD
- Phone Number: 0048 605 152 120
- Email: pawel.balsam@me.com
-
Sub-Investigator:
- Marcin Grabowski, PhD
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Sub-Investigator:
- Michał Peller, MD
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Principal Investigator:
- Paweł Balsam, PhD
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Sub-Investigator:
- Krzysztof Ozierański, MD
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Sub-Investigator:
- Katarzyna Żukowska, student
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Sub-Investigator:
- Katarzyna Szepietowska, student
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Sub-Investigator:
- Martyna Zaleska, student
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Sub-Investigator:
- Kacper Maciejewski, student
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion criteria:
- paroxysmal, persistent, long-standing persistent or permanent AF
- valvular or non-valvular AF
- treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)
Exclusion criteria:
- lack of OAC at hospital discharge
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
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
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.
|
Through the study completion, an average of 3 months.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
|
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.
|
Through the study completion, an average of 3 months.
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Marcin Grabowski, PhD, 1st Department of Cardiology Medical University of Warsaw
- Study Chair: Grzegorz Opolski, Professor, 1st Department of Cardiology Medical University of Warsaw
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CRAFT
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