跳至主要内容
临床试验/NCT03387384
NCT03387384Unknown不适用

Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study

Muğla Sıtkı Koçman University1 个研究点 分布在 1 个国家目标入组 5,000 人开始时间: 2018年6月30日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
5,000
试验地点
1
主要终点
Prevalence of appropriate aspirin use in the primary prevention of cardiovascular diseases

研究概览

简要总结

This study aims to describe the demographic characteristics and current status of the aspirin use for primary and secondary prevention of cardiovascular diseases in a large, multicenter nationwide study

详细描述

Although the benefit of aspirin use for secondary prevention is well established, its role in the primary prevention of cardiovascular diseases remains controversial. Differences in primary prevention guidelines may lead to underuse of aspirin in high-risk patients and overuse in low-risk patients. This study aims to describe the demographic characteristics and current status of the aspirin use for primary and secondary prevention of cardiovascular diseases in a large, multicenter nationwide study. The ASSOS trial (Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study) will be an observational, multicenter, and non-interventional study conducted in Turkey. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

The investigators will enroll all consecutive patients admitted to the outpatient cardiology clinics from January 30, 2018, through May 30, 2018, who were at least 18 years of age, provided written informed consent, and currently treated with aspirin (80-325 mg)within the last 30 days. Hospital-based cardiologists in public units will be invited to participate in the study. Patients will be stratified into 2 categories based on the presence or absence of atherosclerotic cardiovascular disease; secondary prevention group and primary prevention group, respectively. Appropriateness of aspirin use in primary prevention group will be evaluated according to the US Preventive Services Task Force (USPSTF) and European Society of Cardiology (ESC) guidelines. Physicians will complete a standardized survey form to collect information on patient clinical characteristics, cardiovascular risk factors, medical history, clinical examination, laboratory test results, and medications. Patients' risk factors for colorectal cancer and gastrointestinal bleeding will also be questioned.

ASSOS registry will be the largest and most comprehensive study in Turkey evaluating aspirin use. The results of this study will provide valuable information regarding the potential misuse of aspirin in a real-world setting.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients using aspirin 18 years and older

排除标准

  • Patients under 18 years of age
  • Patients who do not want to participate in our study
  • Patients who do not use aspirin

结局指标

主要结局

Prevalence of appropriate aspirin use in the primary prevention of cardiovascular diseases

时间窗: 12 months

Appropriate aspirin use will be defined with US Preventive Services Task Force (USPSTF).

次要结局

未报告次要终点

研究者

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

OGUZHAN CELIK

Faculty of Medicine, Department of Cardiology, M.D., Principal Investigator

Muğla Sıtkı Koçman University

研究点 (1)

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