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Completed

NCT Number: NCT02392416

Atorvastatin Study in Cardiovascular Disease Risk

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.

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Key information

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Gennimatas General State Hospital, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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)
  • 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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

  1. SCORE - Systematic COronary Risk Estimation

    Time frame: 4 months

    Estimation of SCORE

Secondary outcomes

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

    Time frame: 4 months

    Change in 8-item Morisky Scale

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study title

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

Acronym: ANTLER

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 19, 2015
Registry last updated
May 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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