Appropriateness of Aspirin Use in Medical Outpatients

• Conditions: Primary Prevention of Cardiovascular Diseases

• Registration Number: NCT03387384
• Lead Sponsor: Muğla Sıtkı Koçman University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-12-01
• Study First Submitted QC: 2017-12-29
• Study First Posted: 2018-01-02
• Study Start: 2018-06-30
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-14
• Last Update Posted: 2018-12-19
• Primary Completion: 2019-06-30
• Study Completion: 2019-07-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Patients using aspirin 18 years and older

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of appropriate aspirin use in the primary prevention of cardiovascular diseases	12 months	Appropriate aspirin use will be defined with US Preventive Services Task Force (USPSTF).

Trial Locations

Locations (1)

Mugla Sitki Kocman University Training and Research Hospital; 🇹🇷 Mugla, Turkey