MultiCenter expeRience in AFib Patients Treated With OAC (CRAFT)

NCT02987062 | Unknown

• 1 other identifier: CRAFT
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 2

Brief 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). 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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; Non-vitamin K Oral Anticoagulants; Vitamin K Antagonists; ROCKET-AF; RE-LY; ARISTOTLE

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  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

  Through the study completion, an average of 3 months.

• Assessment of long-term outcomes (death, hospitalizations, minor/major/life-threatening bleeding, thromboembolic events)

  Through the study completion, an average of 3 months.

Study Arms (5)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• paroxysmal, persistent, long-standing persistent or permanent AF
• valvular or non-valvular AF
• treatment with OACs (apixaban, dabigatran, rivaroxaban, acenocoumarol, warfarin)

You may not qualify if:

• lack of OAC at hospital discharge

Sponsors & Collaborators

• Medical University of Warsaw: lead

Study Sites (2)

1st Department of Cardiology Medical University of Warsaw

Warsaw, Mazowiecki, 02-097, Poland

RECRUITING

John Paul II Western Hospital

Grodzisk Mazowiecki, 05-825, Poland

RECRUITING

Related Publications (2)

• 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.

  PMID: 38501989 DERIVED

• Balsam 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.

  PMID: 30406937 DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Grzegorz Opolski, Professor

  1st Department of Cardiology Medical University of Warsaw

  STUDY CHAIR

• Marcin Grabowski, PhD

  1st Department of Cardiology Medical University of Warsaw

  STUDY CHAIR

Central Study Contacts

Paweł Balsam, PhD

CONTACT

605 152 120; pawel.balsam@me.com

Krzysztof Ozierański, MD

CONTACT

509 996 947; krzysztof.ozieranski@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor, Marcin Grabowski, Medical University of Warsaw

Study Record Dates

• First Submitted: November 30, 2016
• First Posted: December 8, 2016
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

PL (2)