Hypercholesterolemia Clinical Trial
— ANTLEROfficial title:
Non-interventional, Multicenter Clinical Study to Assess the Treatment With Atorvastatin in Patient Compliance With Hyperlipidemia and Other Cardiovascular Risk Factors
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 |
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.
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 |
Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Greece | Gennimatas General State Hospital | Athens | Attica |
Greece | 2nd Cardiology Department, | University of Athens, Attikon Hospital | Haidari, Athens |
Lead Sponsor | Collaborator |
---|---|
Elpen Pharmaceutical Co. Inc. |
Greece,
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
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 |
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