Atrial Fibrillation in Turkey: Epidemiologic Registry-2

Atrial Fibrillation Clinical Trial

— AFTER-2  

Official title:

An Epidemiological Study to Evaluate the Use of Vitamin K Antagonists and New Oral Anticoagulants Among Nonvalvular Atrial Fibrillation Patients in Turkey

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02354456
• Other study ID #: DicleU
• Status: Recruiting
• Phase: N/A
• First received: January 26, 2015
• Last updated: January 20, 2016
• Start date: January 2015
• Est. completion date: July 2016

Study information

• Verified date: January 2016
• Source: Dicle University
• Contact: Faruk Ertas, Assoc. Prof.
• Phone: 00904122488001
• Email: farukertas[@]hotmail.com
• Is FDA regulated: No
• Health authority: Turkey: Ethics Committee
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Atrial fibrillation (AF) is one of the most common cause of preventable ischemic stroke and associated with increased cardiovascular morbidity and mortality. Our previous AFTER study demonstrated the general epidemiological data about the patients with valvular and nonvalvular AF in Turkey. However, data is lacking about the use of new oral anticoagulants (NOACs), time in therapeutic INR range (TTR) in vitamin K antagonist users and AF management modality in our country. In this multicenter trial the investigators aimed to analyze, follow and evaluate the epidemiological data in non-valvular AF patients.

Description:

Atrial fibrillation (AF) is the most common cause of preventable stroke and strongly associated with increased cardiovascular morbidity and mortality with a prevalence of 1-2% in general population.The first multicenter trial in AF patients in our country, Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER) study, showed that 40% of non-valvular AF patients were on warfarin therapy with an effective INR rate of 37% and the most frequent cause of warfarin underuse was physician neglect. Yet, the use of new oral anticoagulants, time in therapeutic INR range (TTR) in warfarin users and the main management modality (rhythm or rate control) in AF patients have not been studied in Turkey. Therefore, in this multicenter trial, we aimed to assess the extent of effective anticoagulant use (by means of TTR) and epidemiological characteristics of the nonvalvular AF patients with the use of new oral anticoagulants (NOACs) in clinical practice in addition to increased awareness provided by AFTER study.

AFTER-2 study is planned as a prospective, observational and multicenter study with a 6 month and 1-year follow-up of the patients. A total of 4100 patients in 42 centers reflecting the population of the twelve regions of our country according to the Nomenclature of Territorial Units for Statistics will be included in the study.

The detailed characteristics of the patients with non-valvular AF, the rates and kind of oral anticoagulant use, the effect of increased awareness and NOACs on anticoagulant use rate, TTR in warfarin using patients and the bleeding risks of the patients will be determined in this study. At the end of the study, we will question the patients in terms of major adverse events and analyze the independent predictors of these events.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4100
• Est. completion date: July 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 95 Years

Eligibility

Inclusion Criteria:

• All consecutive adult non-valvular AF patients applied to the cardiology clinics with at least one attack of AF identified on electrocardiography without rheumatic mitral valve stenosis and prosthetic valve disease

Exclusion Criteria:

• Patients who will refuse to be a participant or will not sign the consent form

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation

Locations

Country	Name	City	State
Turkey	Dicle Üniversity School of Medicine	Diyarbakir

Sponsors (1)

Lead Sponsor	Collaborator
Dicle University

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Connolly SJ, Wallentin L, Ezekowitz MD, Eikelboom J, Oldgren J, Reilly PA, Brueckmann M, Pogue J, Alings M, Amerena JV, Avezum A, Baumgartner I, Budaj AJ, Chen JH, Dans AL, Darius H, Di Pasquale G, Ferreira J, Flaker GC, Flather MD, Franzosi MG, Golitsyn SP, Halon DA, Heidbuchel H, Hohnloser SH, Huber K, Jansky P, Kamensky G, Keltai M, Kim SS, Lau CP, Le Heuzey JY, Lewis BS, Liu L, Nanas J, Omar R, Pais P, Pedersen KE, Piegas LS, Raev D, Smith PJ, Talajic M, Tan RS, Tanomsup S, Toivonen L, Vinereanu D, Xavier D, Zhu J, Wang SQ, Duffy CO, Themeles E, Yusuf S. The Long-Term Multicenter Observational Study of Dabigatran Treatment in Patients With Atrial Fibrillation (RELY-ABLE) Study. Circulation. 2013 Jul 16;128(3):237-43. doi: 10.1161/CIRCULATIONAHA.112.001139. Epub 2013 Jun 14. — View Citation

Ertas F, Eren NK, Kaya H, Aribas A, Acar G, Kanadasi M, Gedik S, Oylumlu M, Yuksel M, Ulgen MS; AFTER Investigators. The atrial fibrillation in Turkey: Epidemiologic Registry (AFTER). Cardiol J. 2013;20(4):447-52. doi: 10.5603/CJ.a2013.0055. Epub 2013 May 15. — View Citation

Kaya H, Ertas F, Kaya Z, Kahya Eren N, Yüksel M, Köroglu B, Köse N, Yildiz A, Cimen T, Ulgen MS. Epidemiology, anticoagulant treatment and risk of thromboembolism in patients with valvular atrial fibrillation: Results from Atrial Fibrillation in Turkey: Epidemiologic Registry (AFTER). Cardiol J. 2014;21(2):158-62. doi: 10.5603/CJ.a2013.0085. Epub 2013 Jun 25. — View Citation

Yamashita T, Inoue H, Okumura K, Atarashi H, Origasa H; J-RHYTHM Registry Investigators. Warfarin anticoagulation intensity in Japanese nonvalvular atrial fibrillation patients: a J-RHYTHM Registry analysis. J Cardiol. 2015 Mar;65(3):175-7. doi: 10.1016/j.jjcc.2014.07.013. Epub 2014 Aug 26. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of dead patients		1 year	No
Primary	Number of patients with stroke		1 year	No
Primary	Number of patients with major haemorrhage		1 year	Yes
Primary	Number of hospitalization		1 year	No
Secondary	Number of patients with time in therapeutic INR range	Time in therapeutic INR range calculated according to Rosendaal method	1 year	No