A Survey on the Under-treatment of hypercholeSterolemia (... | NCT02608645

Studies
A Survey on the Under-treatment of hypercholeSterolemia (EPHESUS Trial)

NCT02608645

Sponsor

Muğla Sıtkı Koçman University

Status

Unknown status

Last Update Posted

Nov 20, 2015Estimated

Enrollment

6,000Estimated

Phase

Not provided

Conditions

Hyperlipidemias

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2015

Primary Completion Date

Sep 2016Estimated

Completion Date

Sep 2016Estimated

First Submitted Date

Nov 17, 2015

First Submission Date that Met QC Criteria

Nov 18, 2015

First Posted Date

Nov 20, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 18, 2015

Last Update Posted Date

Nov 20, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Murat Biteker, Assoc. Prof. Mugla Sitki Kocman University, Muğla Sıtkı Koçman UniversityPrincipal Investigator

Lead Sponsor

Muğla Sıtkı Koçman UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

6,000Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The number of patients with secondary prevention group receiving appropriate lipid lowering therapy		2 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

acute coronary syndrome in last 1 month
pregnancy or the first 6 months postpartum
ICU patients or emergency patients...etc.(other than polyclinic)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients receiving lipid-lowering therapy within the secondary prevention group in Turkey

Sampling Method

Non-Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
31582673	Derived	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.
29339691

ID	Term
D050171	Dyslipidemias
D052439	Lipid Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases