Appropriateness of Aspirin Use in Medical Outpatients

Primary Prevention of Cardiovascular Diseases Clinical Trial

— ASSOS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03387384
• Other study ID #: MuglaSKU2
• Status: Recruiting
• Start date: June 30, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: December 2018
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5000
• Est. completion date: July 30, 2019
• Est. primary completion date: June 30, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Primary Prevention of Cardiovascular Diseases

Intervention

Other:
• Non-interventional study
Non-interventional study

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Training and Research Hospital	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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