STUDY TO EVALUATE IN CONSECUTIVE PATIENTS WITH CORONARY ARTERY DISEASE THE EFFECT OF DIFFERENT STATINS ON vascular endothelial FUNCTIO
- Conditions
- PATIENTS WITH CORONARY ARTERY DISEASEMedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2012-004188-38-IT
- Lead Sponsor
- IVERSITA' CAMPUS BIOMEDICO
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- Not specified
- diagnosis of coronary artery disease documented by angiography
- Age greater than 18 years
- Willingness to participate in the study, expressed by signing the informed consent
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 60
- Patients with contraindications to statin therapy for history of severe liver disease, muscle disease, or elevated baseline transaminase or CK
- Patients with chronic inflammatory diseases
- Patients with a recent diagnosis of cancer
- Women who are pregnant or lactating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the effects of different statins on endothelial dysfunction, administered at doses characterized by equally effective lipid-lowering in patients with coronary artery disease.;Secondary Objective: incidence of major cardiovascular events (cardiovascular death, myocardial infarction, need for coronary revascularization, unplanned, stroke) at a mean follow-up of 4 weeks; evaluation of the variation of C-reactive protein compared to baseline; reaching the target value of LDL cholesterol , represented by the threshold value of 70 mg / dl, in the various treatment arms.;Primary end point(s): change compared to baseline, markers of endothelial dysfunction (ADMA, FMD and NMD);Timepoint(s) of evaluation of this end point: 6 WEEKS
- Secondary Outcome Measures
Name Time Method Secondary end point(s): incidence of major cardiovascular events (cardiovascular death, myocardial infarction, need for coronary revascularization, unplanned, stroke) at a mean follow-up of 4 weeks; evaluation of the variation of C-reactive protein compared to baseline; reaching the target value of LDL cholesterol , represented by the threshold value of 70 mg / dl, in the various treatment arms.;Timepoint(s) of evaluation of this end point: 6 WEEEKS