Atrial Fibrillation in Turkey: Epidemiologic Registry-2

• Conditions: Atrial Fibrillation

• Registration Number: NCT02354456
• Lead Sponsor: Dicle University

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.

Study Timeline

• Study Start: 2015-01
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-29
• Study First Posted: 2015-02-03
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Last Update Submitted: 2016-01-20
• Last Update Posted: 2016-01-21
• Study Completion: 2016-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 4100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Number of patients with stroke	1 year
Number of dead patients	1 year
Number of patients with major haemorrhage	1 year
Number of hospitalization	1 year

Secondary Outcome Measures

Name	Time	Method
Number of patients with time in therapeutic INR range	1 year	Time in therapeutic INR range calculated according to Rosendaal method

Trial Locations

Locations (1)

Dicle Üniversity School of Medicine; 🇹🇷 Diyarbakir, Turkey