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临床试验/NCT02354456
NCT02354456Unknown不适用

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

Dicle University1 个研究点 分布在 1 个国家目标入组 4,100 人开始时间: 2015年1月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
4,100
试验地点
1
主要终点
Number of dead patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

年龄范围
18 Years 至 95 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

结局指标

主要结局

Number of dead patients

时间窗: 1 year

Number of patients with stroke

时间窗: 1 year

Number of patients with major haemorrhage

时间窗: 1 year

Number of hospitalization

时间窗: 1 year

次要结局

  • Number of patients with time in therapeutic INR range(1 year)

研究者

发起方
Dicle University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Hasan Kaya

Associate Professor of Cardiology

Dicle University

研究点 (1)

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