NCT03329729

PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT

Non-interventional, Multicenter Clinical Trial to Investigate the Efficacy of Rosuvastatin in Patients With Hyperlipidemia and Other Cardiovascular Risk Factors.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 4,700 (actual)
• Sponsor: Elpen Pharmaceutical Co. Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Rosuvastatin is a selective and competitive inhibitor of 3-hydroxy-3-methylglutaric coenzyme A (HMG-CoA), an enzyme regulating the rate of cholesterol synthesis. Its main area of action is the liver. * In cases of primary hypercholesterolaemia (type IIa, including familial hypercholesterolemia heterozygote) or mixed dyslipidaemia (type IIb) as a supplement to diet when dietary and other non-medication responses are inadequate. * In cases of homozygous familial hypercholesterolemia (HoFH), as a supplement to the diet and other lipid-lowering treatments. * In cases of slowing the progression of atherosclerosis. It is indicated as a supplemental treatment of the diet in lowering the total cholesterol (Total C) and LDL-C values. * In patients with hypertriglyceridaemia (excess triglycerides in the blood). Dosage and route of administration * In hyperlipidemia, mixed dyslipidaemia, hypertriglyceridaemia, and slowing the progression of atherosclerosis, the recommended starting dose is 10 mg once a day. * In homozygous familial hypercholesterolemia, the recommended starting dose is 20 mg once a day. * In Asian patients, the recommended starting dose is 5mg once a day. * In patients receiving ciclosporin, the dose of rosuvastatin should be set at 5 mg, while those taking the combination of Lopinavir

Conditions

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

Interventions

Type	Name	Description
OTHER	Rosuvastatin	Hyperlipidemic patients treated with rosuvastatin

Timeline

• Start date: 2018-02-01
• Primary completion: 2019-01-30
• Completion: 2019-01-30
• First posted: 2017-11-06
• Last updated: 2019-05-13

Locations

1 site across 1 country: Greece