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NCT Number: NCT03329729

PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT

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.

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Key information

Conditions

Dyslipidemias Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Quality of Life Risk Factor, Cardiovascular

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Agia Olga Hospital

Athens, Greece

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Rosuvastatin

Other

Hyperlipidemic patients treated with rosuvastatin

Primary outcomes

  1. Time to achieve LDL-C goal

    Time frame: 6 months

    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

Secondary outcomes

  1. CV Risk Factor

    Time frame: 6 months

    Assessing the Cardiovascular Disease Index - 10-year cardiovascular risk

  2. Quality of Life

    Time frame: 6 months

    Assessing Quality of Life in patients with hypercholesterolemia and other risk factors by EQ-5D questionnaire. The EQ- 5D is a descriptive, generic instrument that has also been validated for the Greek population and consists of two parts.25 The first part is a descriptive system of five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The second part consists of a visual analogue scale (VAS), the EQ-VAS, that asks respondents to self-rate themselves on a thermometer-like grading system in order to capture variations in health states. EQ-5D health state valuations may be converted into a single summary index by applying an algorithm that attaches values to each of the levels in each dimension. Value sets have been derived for the EQ-5D scores in several countries using either the VAS or the time trade-off (TTO) valuation technique.

Sponsors and collaborators

Lead sponsor

Elpen Pharmaceutical Co. Inc.

Industry

Registry information

Official study title

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

Acronym: PLATINUM

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 6, 2017
Registry last updated
May 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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