Atrial Fibrillation in Turkey: Epidemiologic Registry-2

NCT ID: NCT02354456

Last Updated: 2016-01-21

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 4100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-07-31

Brief 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.

Detailed 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.

Conditions

Atrial Fibrillation

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 95 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dicle University

OTHER

Sponsor Role: lead

Responsible Party

Hasan Kaya

Associate Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Faruk Ertas, Assoc. Prof.

Role: PRINCIPAL_INVESTIGATOR

Dicle University School of Medicine

Locations

Dicle Üniversity School of Medicine

Diyarbakır, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Faruk Ertas, Assoc. Prof.

Role: CONTACT

farukertas@hotmail.com

00904122488001 ext. 1126

Hasan Kaya, Assoc. Prof.

Role: CONTACT

dr_hasankaya@yahoo.com

00904122488001 ext. 1120

Facility Contacts

Abdulkadir Yildiz, Ass. Prof.

Role: primary

drakadiryildiz@gmail.com

00905052360548

References

Kaya H, Ertas F, Kaya Z, Kahya Eren N, Yuksel M, Koroglu B, Kose 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.

Reference Type: BACKGROUND

PMID: 23799558 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23677730 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 23770747 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25169015 (View on PubMed)

Ertas F, Kaya H, Yildiz A, Davutoglu V, Kiris A, Dinc L, Kafes H, Avci A, Calapkorur B, Ertas G, Gul M, Kahraman Ay N, Bulur S, Durukan M, Eren M, Ilhan I, Kucuk M, Ozpelit E, Simsek H, Ucar FM, Yildiz A, Sahin DY, Ayhan E, Caglayan CE, Gungor H, Ozyurtlu F, Sen N, Vatan B, Vatansever F, Kobat MA, Temiz A, Taylan G, Donmez I, Erkus ME, Soylemez S, Zengin H, Gunduz M, Tuncez A, Karavelioglu Y, Gokdeniz T, Koza Y, Aktop Z, Katlandur H, Karaca Ozer P, Yuksel M, Acet H, Cil H, Alan S, Toprak N. An epidemiological study to evaluate the use of vitamin K antagonists and new oral anticoagulants among non-valvular atrial fibrillation patients in Turkey- AFTER-2 study design. Turk Kardiyol Dern Ars. 2015 Mar;43(2):169-77. doi: 10.5543/tkda.2015.35984.

Reference Type: DERIVED

PMID: 25782122 (View on PubMed)

Other Identifiers

DicleU

Identifier Type: -

Identifier Source: org_study_id