NCT02354456

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
4,100

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2015

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

January 26, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

January 21, 2016

Status Verified

January 1, 2016

Enrollment Period

1 year

First QC Date

January 26, 2015

Last Update Submit

January 20, 2016

Conditions

Keywords

atrial fibrillationepidemiologyantiocaogulation

Outcome Measures

Primary Outcomes (4)

  • Number of dead patients

    1 year

  • Number of patients with stroke

    1 year

  • Number of patients with major haemorrhage

    1 year

  • Number of hospitalization

    1 year

Secondary Outcomes (1)

  • Number of patients with time in therapeutic INR range

    1 year

Eligibility Criteria

Age18 Years - 95 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

nonvalvular atrial fibrillation

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dicle Üniversity School of Medicine

Diyarbakır, 21280, Turkey (Türkiye)

RECRUITING

Related Publications (5)

  • 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.

    PMID: 23799558BACKGROUND
  • 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.

    PMID: 23677730BACKGROUND
  • 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.

    PMID: 23770747BACKGROUND
  • 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.

    PMID: 25169015BACKGROUND
  • 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.

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Faruk Ertas, Assoc. Prof.

    Dicle University School of Medicine

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Faruk Ertas, Assoc. Prof.

CONTACT

Hasan Kaya, Assoc. Prof.

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Cardiology

Study Record Dates

First Submitted

January 26, 2015

First Posted

February 3, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

July 1, 2016

Last Updated

January 21, 2016

Record last verified: 2016-01

Locations