PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT
- Conditions
- HyperlipidemiasDyslipidemiasQuality of LifeRisk Factor, Cardiovascular
- Interventions
- Other: Rosuvastatin
- Registration Number
- NCT03329729
- Lead Sponsor
- Elpen Pharmaceutical Co. Inc.
- 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.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 4700
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hyperlipidemic patients Rosuvastatin -
- Primary Outcome Measures
Name Time Method Time to achieve LDL-C goal 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 Outcome Measures
Name Time Method CV Risk Factor 6 months Assessing the Cardiovascular Disease Index - 10-year cardiovascular risk
Quality of Life 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.
Trial Locations
- Locations (1)
Agia Olga Hospital
🇬🇷Athens, Greece