HyperlipidemiasEPHESUSNCT02608645
A Survey on the Under-treatment of hypercholeSterolemia (EPHESUS Trial)
An observational study of Hyperlipidemias, run by Muğla Sıtkı Koçman University.
Trial summary
In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hyperlipidemias
- How many people
- 6,000 participants
- Where
- No sites listed yet
- Study dates
- Nov 2015to Sep 2016
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients receiving lipid-lowering therapy within the secondary prevention group in Turkey
Who may be able to join
- Patients with coronary artery disease (acute coronary syndromes, post- myocardial infarction patients, who have a history of percutaneous coronary intervention , history of coronary artery by-pass graft )
- Patients with carotid artery lesions or peripheral artery disease ,
- Type 2 diabetes mellitus patients
Who cannot join
- acute coronary syndrome in last 1 month
- pregnancy or the first 6 months postpartum
- ICU patients or emergency patients...etc.(other than polyclinic)
About this study
Official title: Evaluation of Perceptions, Knowledge and Compliance With tHE Guidelines for Secondary Prevention in Real Life Practice: A Survey on the Under-treatment of hypercholeSterolemia (EPHESUS Trial)
In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.
Read the detailed description
In the majority of patients treated with lipid lowering agents are not under control in accordance with the lipids manual. In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.
The investigators' aim is to determine the role of education and knowledge in reaching target LDL cholesterol levels in these patients. İn addition , the investigators want to emphasize in high-risk patients who are receiving or not receiving cholesterol-lowering treatment what is their target values , (LDL < 100 mg / dL and high -risk patients with LDL < 70 mg / dL in very high-risk patients ) and to determine what is the rate of patients and to the importance of reaching their target cholesterol levels. İn addition ,to evaluate the patients habits of the using statin dose .After screening , physician treatment decisions and reasons will be documented.
- Conditions
- Hyperlipidemias
- Medical subject headings
- Hyperlipidemias
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of patients with secondary prevention group receiving appropriate lipid lowering therapy
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2015 (estimated)
- Study startNov 2015
- Primary completionSep 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HyperlipidemiasStudies 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
- Time perspective
- Prospective
- Enrolment
- 6,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Biteker, Muğla Sıtkı Koçman University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02608645
- Sponsor's protocol ID
- EPHESUS trial
- Acronym
- EPHESUS
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 20 Nov 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Dogan V, Basaran O, Ozlek B, Celik O, Ozlek E, Cil C, Ozdemir IH, Rencuzogullari I, Ozpamuk Karadeniz F, Bekar L, Aktas M, Resulzade MM, Kalcik M, Aksan G, Cinier G, Halli Akay K, Mert KU, Biteker M, Kayikcioglu M. Evaluation of perceptions, knowledge and compliance with guidelines in real-life practice: A survey on the under-treatment of hypercholesterolemia. Turk Kardiyol Dern Ars. 2019 Oct;47(7):599-608. doi: 10.5543/tkda.2019.39293.
PubMed 31582673Dogan V, Basaran O, Ozlek B, Celik O, Ozlek E, Mert KU, Rencuzogullari I, Mert GO, Dogan MM, Biteker M, Kayikcioglu M. Rationale, design, and methodology of the Evaluation of Perceptions, Knowledge, and Compliance with the Guidelines in Real Life Practice: A Survey on the Under-treatment of Hypercholesterolemia. Turk Kardiyol Dern Ars. 2018 Jan;46(1):47-53. doi: 10.5543/tkda.2017.73861.
PubMed 29339691
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Perceptions, Knowledge and Compliance With tHE Guidelines for Secondary Prevention in Real Life Practice: A Survey on the Under-treatment of hypercholeSterolemia (EPHESUS Trial)
- ClinicalTrials.gov ID
- NCT02608645
- Acronym / sponsor ID
- EPHESUS / EPHESUS trial
- Conditions
- Hyperlipidemias
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6,000 participants (estimated)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- Nov 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 20 Nov 2015 (estimated)
- 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.
In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.
Detailed description
In the majority of patients treated with lipid lowering agents are not under control in accordance with the lipids manual. In this study, within the secondary prevention group patients ( diabetes mellitus, coronary artery disease, peripheral artery disease, who have had events atherosclerotic cerebrovascular ) , statin use requirement , patients compliance and reaching target LDL-cholesterol levels (according to European guidelines ) will be evaluated.
The investigators' aim is to determine the role of education and knowledge in reaching target LDL cholesterol levels in these patients. İn addition , the investigators want to emphasize in high-risk patients who are receiving or not receiving cholesterol-lowering treatment what is their target values , (LDL < 100 mg / dL and high -risk patients with LDL < 70 mg / dL in very high-risk patients ) and to determine what is the rate of patients and to the importance of reaching their target cholesterol levels. İn addition ,to evaluate the patients habits of the using statin dose .After screening , physician treatment decisions and reasons will be documented.
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients receiving lipid-lowering therapy within the secondary prevention group in Turkey
Key inclusion criteria (3 listed)
- Patients with coronary artery disease (acute coronary syndromes, post- myocardial infarction patients, who have a history of percutaneous coronary intervention , history of coronary artery by-pass graft )
- Patients with carotid artery lesions or peripheral artery disease ,
- Type 2 diabetes mellitus patients
Key exclusion criteria (3 listed)
- acute coronary syndrome in last 1 month
- pregnancy or the first 6 months postpartum
- ICU patients or emergency patients...etc.(other than polyclinic)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The number of patients with secondary prevention group receiving appropriate lipid lowering therapy
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2015.
- Derived from this study: PubMed 31582673Dogan V, Basaran O, Ozlek B, Celik O, Ozlek E, Cil C, Ozdemir IH, Rencuzogullari I, Ozpamuk Karadeniz F, Bekar L, Aktas M, Resulzade MM, Kalcik M, Aksan G, Cinier G, Halli Akay K, Mert KU, Biteker M, Kayikcioglu M. Evaluation of perceptions, knowledge and compliance with guidelines in real-life practice: A survey on the under-treatment of hypercholesterolemia. Turk Kardiyol Dern Ars. 2019 Oct;47(7):599-608. doi: 10.5543/tkda.2019.39293.
- Derived from this study: PubMed 29339691Dogan V, Basaran O, Ozlek B, Celik O, Ozlek E, Mert KU, Rencuzogullari I, Mert GO, Dogan MM, Biteker M, Kayikcioglu M. Rationale, design, and methodology of the Evaluation of Perceptions, Knowledge, and Compliance with the Guidelines in Real Life Practice: A Survey on the Under-treatment of Hypercholesterolemia. Turk Kardiyol Dern Ars. 2018 Jan;46(1):47-53. doi: 10.5543/tkda.2017.73861.
Related trials for Hyperlipidemias
Not yet recruiting
Plasma Lipids-Dependent Vitamin E Metabolism During Dynamic Hyperlipidemia
Lipid Metabolism Disorders
Active, not recruiting
Developing a Learning COmmunity to Increase eNgagemeNt and Enrollment in Cardiovascular Clinical Trials (CONNECT)
Cardiovascular Diseases, Hypertension
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
RecruitingObservational study
Causes and Natural History of Dyslipidemias
Hypercholesterolemia, Atherosclerosis
Active, not recruitingObservational study
Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
Familial Hypercholesterolaemia
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperlipidemias, run by Muğla Sıtkı Koçman University.
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 3 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 20 Nov 2015. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of patients with secondary prevention group receiving appropriate lipid lowering therapy (time frame: 2 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 NCT02608645, which also lists 2 linked publications.
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 20 Nov 2015.