MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT) (CRAFT)

June 7, 2017 updated by: Marcin Grabowski, Medical University of Warsaw

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

Unknown

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

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

      • Grodzisk Mazowiecki, Poland, 05-825
        • Recruiting
        • John Paul II Western Hospital
        • Contact:
          • Janusz Bednarski, PhD
        • Principal Investigator:
          • Janusz Bednarski, PhD
    • Mazowiecki
      • Warsaw, Mazowiecki, Poland, 02-097
        • Recruiting
        • 1st Department of Cardiology Medical University of Warsaw
        • Sub-Investigator:
          • Grzegorz Opolski, Professor
        • Sub-Investigator:
          • Agata Tymińska, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Marcin Grabowski, PhD
        • Sub-Investigator:
          • Michał Peller, MD
        • Principal Investigator:
          • Paweł Balsam, PhD
        • Sub-Investigator:
          • Krzysztof Ozierański, MD
        • Sub-Investigator:
          • Katarzyna Żukowska, student
        • Sub-Investigator:
          • Katarzyna Szepietowska, student
        • Sub-Investigator:
          • Martyna Zaleska, student
        • Sub-Investigator:
          • Kacper Maciejewski, student

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

April 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

November 30, 2016

First Submitted That Met QC Criteria

December 6, 2016

First Posted (Estimate)

December 8, 2016

Study Record Updates

Last Update Posted (Actual)

June 8, 2017

Last Update Submitted That Met QC Criteria

June 7, 2017

Last Verified

June 1, 2017

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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