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HypercholesterolemiaANTLERNCT02392416

Atorvastatin Study in Cardiovascular Disease Risk

An observational study of Hypercholesterolemia and Dyslipidemia, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias) These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation and taking into account specific parameters… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Hypercholesterolemia, Dyslipidemia
How many people
900 participants
Where
2 sitesGreece
Study dates
Apr 2015to Feb 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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients with dyslipidemia

Who may be able to join

  • External outpatients who monitored externally hospital lipid clinic, hypercholesterolemia, diabetic etc.
  • Male or female
  • Eligible ages for the study: 18-99 years
  • Patients with a first diagnosis of hypercholesterolemia who are to receive Atorvastatini according to standard clinical practice
  • Established cardiovascular disease by interventional or non-interventional examinations (such as coronary angiography, nuclear medicine, echocardiography stress, carotid plaque ultrasound), previous myocardial infarction, ACS, coronary revascularization (PCI, CABG), and other arterial revascularization procedures, ischemic stroke, peripheral arterial disease (PAD)
  • Diabetes mellitus (type 1 or type 2) with one or more cardiovascular risk factors and / or target organ damage (such as microalbuminuria: 30-300 mg / 24 h)
Show all 9Show fewer
  • Patients already diagnosed with hypercholesterolemia and unregulated who will receive Atorvastatini according to standard clinical practice
  • Patients diagnosed and set to original formulation of atorvastatin
  • Patients who have fully understood the study protocol and signed the consent form

Who cannot join

  • Patients <18 years
  • Hypersensitivity to atorvastatin or to any of the excipients
  • Women pregnant or breastfeeding
  • Patients who have not fully understood the study protocol and have not signed the consent form

Trial locations and contacts

2 sites in 1 country.

Greece2 sites

  • Gennimatas General State Hospital

    Athens, Attica

  • 2nd Cardiology Department,

    University of Athens, Attikon Hospital, Haidari, Athens, 12462

Other trials in Greece

About this study

Official title: Non-interventional, Multicenter Clinical Study to Assess the Treatment With Atorvastatin in Patient Compliance With Hyperlipidemia and Other Cardiovascular Risk Factors

Treatment of hypercholesterolemia is based on the guidelines of ESC-EAS 2011 (European Heart Journal (2011) 32, 1769-1818, ESC / EAS Guidelines for the management of dyslipidaemias) These calculate the 10 year risk based on SCORE tables - Systematic COronary Risk Estimation and taking into account specific parameters in the patient's profile.

Read the detailed description

The European Society of Cardiology initiated the development of a new risk calculation system (SCORE) using data from 12 European population monitoring studies (N = 205.178) with wide geographic distribution of countries with different cardiovascular risk. The SCORE data contains more than 3 million man-years of observation and 7934 fatal cardiovascular events.

  • patient is classified into risk category (Very high-high-medium-low)
  • a target for LDL-C was then placed on a risk basis and appropriate treatment proposed
  • As a first option is to statin monotherapy to the maximum tolerated dose.
  • Only in case of failure of the therapeutic target for LDL-C may be used active substance other therapeutic class or as alternative monotherapy or in combination with statin, Because European countries exhibit heterogeneity in genetics, lifestyle, living standards, health benefits, etc. have been divided into two groups, high risk (countries) and low risk (countries) and have been prepared in different tables SCORE (Systematic COronary Risk Estimation) For Greece, as in other countries has been further refinement of SCORE and trained specialists tables adapted to the Greek population (Statistical The most currently used treatment in Greece is atorvastatin, obtained from 520,000 patients From far studies with atorvastatin have been well documented reductions in various lipid parameters and especially the LDL-C, which is the main objective in the treatment.

But there is no evidence to suggest what is the dosage proved suitable in practice for the patient depending on the risk class belongs.

Medical subject headings
Hypercholesterolemia, Dyslipidemias

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. SCORE - Systematic COronary Risk Estimation

    Estimation of SCORE

    Measured: 4 months

Secondary outcomes (1)

  1. Compliance (Change in 8-item Morisky Scale)

    Change in 8-item Morisky Scale

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Mar 2015 (estimated)
  2. Study startApr 2015
  3. Primary completionFeb 2016
  4. Study completionFeb 2016

Resources

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
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02392416
Sponsor's protocol ID
2015-ATR-EL-56
Acronym
ANTLER
Status last verified
May 2016
First submitted
13 Mar 2015
Last updated
18 May 2016
Results posted
No
Data monitoring committee
No

Publications

  • Pitsavos C, Panagiotakos DB, Chrysohoou C, Stefanadis C. Epidemiology of cardiovascular risk factors in Greece: aims, design and baseline characteristics of the ATTICA study. BMC Public Health. 2003 Oct 20;3:32. doi: 10.1186/1471-2458-3-32.

    PubMed 14567760

  • Panagiotakos DB, Pitsavos C, Manios Y, Polychronopoulos E, Chrysohoou CA, Stefanadis C. Socio-economic status in relation to risk factors associated with cardiovascular disease, in healthy individuals from the ATTICA study. Eur J Cardiovasc Prev Rehabil. 2005 Feb;12(1):68-74.

    PubMed 15703509

  • Morisky DE, Ang A, Krousel-Wood M, Ward HJ. Predictive validity of a medication adherence measure in an outpatient setting. J Clin Hypertens (Greenwich). 2008 May;10(5):348-54. doi: 10.1111/j.1751-7176.2008.07572.x.

    PubMed 18453793

  • Krousel-Wood M, Islam T, Webber LS, Re RN, Morisky DE, Muntner P. New medication adherence scale versus pharmacy fill rates in seniors with hypertension. Am J Manag Care. 2009 Jan;15(1):59-66.

    PubMed 19146365

  • Morisky DE, DiMatteo MR. Improving the measurement of self-reported medication nonadherence: response to authors. J Clin Epidemiol. 2011 Mar;64(3):255-7; discussion 258-63. doi: 10.1016/j.jclinepi.2010.09.002. Epub 2010 Dec 8. No abstract available.

    PubMed 21144706

Questions about this trial

What is this clinical trial studying?

An observational study of Hypercholesterolemia and Dyslipidemia, run by Elpen Pharmaceutical Co. Inc. at 2 sites in Greece.

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 9 inclusion and 4 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: finished, as of the sponsor's last update on 18 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Greece. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

SCORE - Systematic COronary Risk Estimation (time frame: 4 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 NCT02392416, which also lists 5 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 18 May 2016.

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Atorvastatin Study in Cardiovascular Disease Risk | AzTrials