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STUDY TO EVALUATE IN CONSECUTIVE PATIENTS WITH CORONARY ARTERY DISEASE THE EFFECT OF DIFFERENT STATINS ON vascular endothelial FUNCTIO

Conditions
PATIENTS WITH CORONARY ARTERY DISEASE
MedDRA version: 14.1Level: SOCClassification code 10007541Term: Cardiac disordersSystem Organ Class: 10007541 - Cardiac disorders
Therapeutic 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
Inclusion Criteria

- 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

Exclusion Criteria

- 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
NameTimeMethod
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
NameTimeMethod
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
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