Status:
COMPLETED
PLATOREL® STUDY IN CARDIOVASCULAR RISΚ ASSESMENT
Lead Sponsor:
Elpen Pharmaceutical Co. Inc.
Conditions:
Dyslipidemias
Hyperlipidemias
Eligibility:
All Genders
18-80 years
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. ...
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. ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 30 2019
Estimated Enrollment :
4700 Patients enrolled
Trial Details
Trial ID
NCT03329729
Start Date
February 1 2018
End Date
January 30 2019
Last Update
May 13 2019
Active Locations (1)
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1
Agia Olga Hospital
Athens, Greece