NCT02392416

Atorvastatin Study in Cardiovascular Disease Risk

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 900 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

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 in the patient's profile.

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.

Conditions

• Hypercholesterolemia
• Dyslipidemia

Timeline

• Start date: 2015-04-01
• Primary completion: 2016-02-01
• Completion: 2016-02-01
• First posted: 2015-03-19
• Last updated: 2016-05-18

Locations

2 sites across 1 country: Greece