Appropriateness of Aspirin Use in Medical Outpatients (ASSOS)

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

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

Study Overview

• Status: Unknown
• Conditions: Primary Prevention of Cardiovascular Diseases
• Intervention / Treatment: Other: Non-interventional 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 Type: Observational
• Enrollment (Anticipated): 5000

Contacts and Locations

Study Locations

• Turkey
  • Mugla, Turkey
    • Recruiting
    • Mugla Sitki Kocman University Training and Research Hospital
    • Contact: CEM ÇİL, M.D.; Phone Number: +90. 252 214 13 23; Email: drcemcil@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients over the age of 18 using aspirin who presented to cardiology outpatient clinics will be screened

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University

Publications and helpful links

General Publications

• Celik O, Cil C, Ozlek B, Ozlek E, Dogan V, Basaran O, Demirci E, Bekar L, Kalcik M, Karaarslan O, Yetim M, Dogan T, Demir V, Kalkan S, Ozkan B, Hidayet S, Taylan G, Kucuksu Z, Celik Y, Efe SC, Aslan O, Biteker M. Design and rationale for the ASSOS study: Appropriateness of aspirin use in medical outpatients a multicenter and observational study. Anatol J Cardiol. 2018 Dec;20(6):354-362. doi: 10.14744/AnatolJCardiol.2018.47587.

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2018
• Primary Completion (Anticipated): June 30, 2019
• Study Completion (Anticipated): July 30, 2019

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 29, 2017
• First Posted (Actual): January 2, 2018

Study Record Updates

• Last Update Posted (Actual): December 19, 2018
• Last Update Submitted That Met QC Criteria: December 14, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases
• Other Study ID Numbers: MuglaSKU2

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No