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

Prospective randomized study FOR THE ASSESSMENT OF EFFECTS OF DIFFERENT Statins ON ENDOTHELIAL FUNCTION IN PATIENTS WITH CORONARY ARTERY DISEASE

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2012-004188-38-IT
Enrollment
Unknown
Registered
2012-11-23
Start date
2012-10-30
Completion date
Unknown
Last updated
2014-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

PATIENTS WITH CORONARY ARTERY DISEASE MedDRA version: 14.1 Level: SOC Classification code 10007541 Term: Cardiac disorders System Organ Class: 10007541 - Cardiac disorders

Interventions

Pharmaceutical Form: Tablet CAS Number: 79902-63-9 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 20- Pharmaceutical Form: Tablet CAS Number: 134523-00-5 Concentr

Sponsors

UNIVERSITA' CAMPUS BIOMEDICO
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

Italy

Contacts

Public ContactDIPARTIMENTO DI SCIENZE CARDIOVASCO

UNIVERSITA' CAMPUS BIO-MEDICO DI ROMA

g.patti@unicampus.it06225411612

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026