Atorvastatin Study in Cardiovascular Disease Risk

Hypercholesterolemia Clinical Trial

— ANTLER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392416
• Other study ID #: 2015-ATR-EL-56
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: May 17, 2016
• Start date: April 2015
• Est. completion date: February 2016

Study information

• Verified date: May 2016
• Source: Elpen Pharmaceutical Co. Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Greece: National Organization of Medicines
• Study type: Observational

Clinical 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 in the patient's profile.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Dyslipidemia
• Dyslipidemias
• Hypercholesterolemia

Locations

Country	Name	City	State
Greece	Gennimatas General State Hospital	Athens	Attica
Greece	2nd Cardiology Department,	University of Athens, Attikon Hospital	Haidari, Athens

Sponsors (1)

Lead Sponsor	Collaborator
Elpen Pharmaceutical Co. Inc.

Country where clinical trial is conducted

Greece, 

References & Publications (5)

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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SCORE - Systematic COronary Risk Estimation	Estimation of SCORE	4 months	Yes
Secondary	Compliance (Change in 8-item Morisky Scale)	Change in 8-item Morisky Scale	4 months	No