PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT

NCT03329729 | Completed

• 1 other identifier: 2017-RSV-EL-78
• Study Type: observational
• Target: 4,700
• Locations: 1 country
• Sites: 1

Brief Summary

Dyslipidemias are a major risk factor for the onset of cardiovascular disease, while early diagnosis and appropriate treatment approaches significantly reduce cardiovascular morbidity and mortality. The aim is to provide revised Greek guidelines for the diagnosis and treatment of dyslipidaemias. The lipids of the human body are cholesterol (it is used to synthesize cell membranes, adrenal hormones and gonads and is a component of bile) and triglycerides (used as a fuel and as a storage of energy in adipose tissue). Dyslipidemias are disorders (quantitative or qualitative) of the metabolism of lipoprotein particles \[low density lipoproteins (LDL), chylomic, high density lipoproteins (HDL), very low density lipoproteins (VLDL)\] that carry lipids into the body. Primary prevention in subjects aged 40-65 years with no known clinical atherosclerotic disease and without diabetes or chronic renal disease should evaluate the likelihood of a fatal cardiovascular event over the next 10 years. For this purpose, it is recommended to use the Greek version of the SCORE of the Hellenic Heart SCORE.

Conditions

Dyslipidemias; Hyperlipidemias; Risk Factor, Cardiovascular; Quality of Life

Outcome Measures

Primary Outcomes (1)

• Time to achieve LDL-C goal

  To evaluate the efficacy of rosuvastatin in patients with hypercholesterolemia in achieving the target lipid level (LDL-C, HDL-C, T-CHOL) in patients' blood plasma

  6 months

Secondary Outcomes (2)

• CV Risk Factor

  6 months

• Quality of Life

  6 months

Study Arms (1)

Hyperlipidemic patients

Other: Rosuvastatin

Interventions

Rosuvastatin OTHER

Hyperlipidemic patients treated with rosuvastatin

Hyperlipidemic patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dyslipidemia and other risk factors treated with rosuvastatin

You may qualify if:

• Outpatient Patients who are monitored at an external hospital for lipids, hypercholesterolemia, diabetes,
• Male or female
• Eligible ages for study: 18 - 99 years
• Patients diagnosed with hypercholesterolemia who are to receive Rosuvastatin according to established clinical practice
• Acquired cardiovascular disease from invasive or non-invasive examinations (such as coronary angiography, nuclear medicine, stress echocardiography, carotid plaque ultrasound), previous myocardial infarction, ACS, coronary revascularization (PCI, CABG), and other arterial revascularization, ischemic cerebrovascular accident, peripheral arterial disease (PAD) Diabetes mellitus (type 1 or type 2) with one or more cardiovascular risk factors orand target organ damage (such as microalbuminuria: 30-300 mg Patients already diagnosed with hypercholesterolemia and non-regulated who are going to receive Rosuvastatin according to established clinical practice
• Patients who have fully understood the study protocol and have signed the consent document
• Compliance with study procedures

You may not qualify if:

• Patients \<18 years
• Hypersensitivity to Rosuvastatin or to any of the excipients
• Women in gestation or lactation
• Patients who have not fully understood the study protocol and have not signed the consent document

Sponsors & Collaborators

• Elpen Pharmaceutical Co. Inc.: lead

Study Sites (1)

Agia Olga Hospital

Athens, Greece

Location

Related Publications (10)

• Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WMM, Vlachopoulos C, Wood DA, Zamorano JL, Cooney MT; ESC Scientific Document Group. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias. Eur Heart J. 2016 Oct 14;37(39):2999-3058. doi: 10.1093/eurheartj/ehw272. Epub 2016 Aug 27. No abstract available.

  PMID: 27567407 BACKGROUND

• European Association for Cardiovascular Prevention & Rehabilitation; Reiner Z, Catapano AL, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Filardi PP, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines (CPG) 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Eur Heart J. 2011 Jul;32(14):1769-818. doi: 10.1093/eurheartj/ehr158. Epub 2011 Jun 28.

  PMID: 21712404 BACKGROUND

• Authors/Task Force Members:; Catapano AL, Graham I, De Backer G, Wiklund O, Chapman MJ, Drexel H, Hoes AW, Jennings CS, Landmesser U, Pedersen TR, Reiner Z, Riccardi G, Taskinen MR, Tokgozoglu L, Verschuren WM, Vlachopoulos C, Wood DA, Zamorano JL. 2016 ESC/EAS Guidelines for the Management of Dyslipidaemias: The Task Force for the Management of Dyslipidaemias of the European Society of Cardiology (ESC) and European Atherosclerosis Society (EAS) Developed with the special contribution of the European Assocciation for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis. 2016 Oct;253:281-344. doi: 10.1016/j.atherosclerosis.2016.08.018. Epub 2016 Sep 1. No abstract available.

  PMID: 27594540 BACKGROUND

• Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS); Catapano AL, Reiner Z, De Backer G, Graham I, Taskinen MR, Wiklund O, Agewall S, Alegria E, Chapman MJ, Durrington P, Erdine S, Halcox J, Hobbs R, Kjekshus J, Perrone Filardi P, Riccardi G, Storey RF, Wood D; ESC Committee for Practice Guidelines 2008-2010 and 2010-2012 Committees. ESC/EAS Guidelines for the management of dyslipidaemias: the Task Force for the management of dyslipidaemias of the European Society of Cardiology (ESC) and the European Atherosclerosis Society (EAS). Atherosclerosis. 2011 Jul;217 Suppl 1:S1-44. doi: 10.1016/j.atherosclerosis.2011.06.012. No abstract available.

  PMID: 21723445 BACKGROUND

• Hamm CW, Bassand JP, Agewall S, Bax J, Boersma E, Bueno H, Caso P, Dudek D, Gielen S, Huber K, Ohman M, Petrie MC, Sonntag F, Uva MS, Storey RF, Wijns W, Zahger D; ESC Committee for Practice Guidelines. ESC Guidelines for the management of acute coronary syndromes in patients presenting without persistent ST-segment elevation: The Task Force for the management of acute coronary syndromes (ACS) in patients presenting without persistent ST-segment elevation of the European Society of Cardiology (ESC). Eur Heart J. 2011 Dec;32(23):2999-3054. doi: 10.1093/eurheartj/ehr236. Epub 2011 Aug 26. No abstract available.

  PMID: 21873419 BACKGROUND

• Panagiotakos DB, Fitzgerald AP, Pitsavos C, Pipilis A, Graham I, Stefanadis C. Statistical modelling of 10-year fatal cardiovascular disease risk in Greece: the HellenicSCORE (a calibration of the ESC SCORE project). Hellenic J Cardiol. 2007 Mar-Apr;48(2):55-63.

  PMID: 17489342 BACKGROUND

• Panagiotakos DB, Georgousopoulou EN, Fitzgerald AP, Pitsavos C, Stefanadis C. Validation of the HellenicSCORE (a Calibration of the ESC SCORE Project) Regarding 10-Year Risk of Fatal Cardiovascular Disease in Greece. Hellenic J Cardiol. 2015 Jul-Aug;56(4):302-8.

  PMID: 26233769 BACKGROUND

• 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.

  PMID: 14567760 BACKGROUND

• 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.

  PMID: 15703509 BACKGROUND

• Kontodimopoulos N, Pappa E, Niakas D, Tountas Y. Validity of SF-12 summary scores in a Greek general population. Health Qual Life Outcomes. 2007 Sep 28;5:55. doi: 10.1186/1477-7525-5-55.

  PMID: 17900374 BACKGROUND

MeSH Terms

Conditions

Dyslipidemias; Hyperlipidemias

Interventions

Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2017
• First Posted: November 6, 2017
• Study Start: February 1, 2018
• Primary Completion: January 30, 2019
• Study Completion: January 30, 2019
• Last Updated: May 13, 2019

Record last verified: 2018-12

Locations

GR (1)