Primary Prevention of Cardiovascular DiseasesASSOSNCT03387384
Appropriateness of Aspirin Use in Medical Outpatients
An observational study of Primary Prevention of Cardiovascular Diseases, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Primary Prevention of Cardiovascular Diseases
- What is being tested?
- Non-interventional study
- How many people
- 5,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jun 2018to 30 Jul 2019
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: All consecutive patients over the age of 18 using aspirin who presented to cardiology outpatient clinics will be screened
Who may be able to join
- Patients using aspirin 18 years and older
Who cannot join
- Patients under 18 years of age
- Patients who do not want to participate in our study
- Patients who do not use aspirin
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mugla Sitki Kocman University Training and Research Hospital
Muğla
CEM ÇİL, M.D., +90. 252 214 13 23, drcemcil@gmail.com
About this study
Official title: 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
Read the 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.
- Being tested
- Non-interventional study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-interventional studyOther
Non-interventional study
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2018
- Study start30 Jun 2018
- Primary completion30 Jun 2019 (estimated)
- Study completion30 Jul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary Prevention of Cardiovascular DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, OGUZHAN CELIK, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03387384
- Sponsor's protocol ID
- MuglaSKU2
- Acronym
- ASSOS
- Status last verified
- Dec 2018
- First submitted
- 1 Dec 2017
- Last updated
- 19 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 30504736
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Appropriateness of Aspirin Use in Medical Outpatients: A Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT03387384
- Acronym / sponsor ID
- ASSOS / MuglaSKU2
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 30 Jun 2019 (estimated)
- Study completion
- 30 Jul 2019 (estimated)
- First posted
- 2 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All consecutive patients over the age of 18 using aspirin who presented to cardiology outpatient clinics will be screened
Key inclusion criteria (1 listed)
- Patients using aspirin 18 years and older
Key exclusion criteria (3 listed)
- Patients under 18 years of age
- Patients who do not want to participate in our study
- Patients who do not use aspirin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-interventional studyNon-interventional study | Other | – |
Primary outcome
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2018.
- Derived from this study: PubMed 30504736Celik 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mugla Sitki Kocman University Training and Research Hospital
Muğla, Turkey (Türkiye)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Prevention of Cardiovascular Diseases, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Dec 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of appropriate aspirin use in the primary prevention of cardiovascular diseases (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03387384, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2018.