Clinical trial NCT02392416: Atorvastatin Study in Cardiovascular Disease Risk
Official title: Non-interventional, Multicenter Clinical Study to Assess the Treatment With Atorvastatin in Patient Compliance With Hyperlipidemia and Other Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypercholesterolemia
Dyslipidemia
Lead sponsor: Elpen Pharmaceutical Co. Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-19
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dyslipidemia

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: SCORE - Systematic COronary Risk Estimation
timeFrame: 4 months
Secondary outcomes:
measure: Compliance (Change in 8-item Morisky Scale)
timeFrame: 4 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Gennimatas General State Hospital
state: Attica
city: University of Athens, Attikon Hospital
country: Greece
facility: 2nd Cardiology Department,
state: Haidari, Athens
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.