candidates patients for percutaneous coronary intervention revascularization on the basis of claims made by the current guidelines in accordance with the criteria of inclusion / exclusion protocol MedDRA version: 9.1 Level: LLT Classification code 10057787 MedDRA version: 9.1 Level: HLGT Classification code 10011082
Conditions
Sponsors
OSPEDALE G.PASQUINUCCI-FONDAZIONE TOSCANA GABRIELE MONASTERIO
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. presence of typical stable effort angina 2. positive stress test (either ECG, nuclear scan, or stress echocardiogram) 3. indication for coronary angioplast. 4. Provide written informed consent before randomization. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. acute myocardial infarction (3 mg/dL; 7. history of liver or muscle disease; 8. Systemic autoimmune and inflammatory diseases 9. Participation in any phase of another clinical research study involving the evaluation of another investigational drug or device within 30 days prior to randomization 10. Inability to give at least verbal informed consent to the study. 11. Counter indications foreseen in medical information pamphlet
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: impact of atorvastatin treatment on sLOX-1 serum levels, from the time of treatment initiation until 6 months of follow-up.;Secondary Objective: to evaluate in diabetic patients with stable coronary artery disease undergoing PTCA, strict lipid controls achieved with aggressive atorvastatin therapy which will translate into a functional benefit;Primary end point(s): effects of atorvastatin treatment on sLOX-1 levels , from the begining of treatment upto 6 months follow-up | — |
Countries
Italy
Outcome results
None listed