Appropriateness of Aspirin Use in Medical Outpatients (ASSOS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03387384|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : December 18, 2018
|Condition or disease||Intervention/treatment|
|Primary Prevention of Cardiovascular Diseases||Other: Non-interventional study|
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 [Patient Registry]|
|Estimated Enrollment :||5000 participants|
|Target Follow-Up Duration:||1 Day|
|Official Title:||Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study|
|Actual Study Start Date :||June 30, 2018|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||July 30, 2019|
- Other: Non-interventional study
- Prevalence of appropriate aspirin use in the primary prevention of cardiovascular diseases [ Time Frame: 12 months ]Appropriate aspirin use will be defined with US Preventive Services Task Force (USPSTF).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387384
|Mugla Sitki Kocman University Training and Research Hospital||Recruiting|
|Contact: CEM ÇİL, M.D. +90. 252 214 13 23 firstname.lastname@example.org|