Effects of periprocedural atorvastatin therapy on patients undergoing percutaneous coronary intervention (PCI) - ATTICA

Conditions: 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: 9.1Level: LLTClassification code 10057787
MedDRA version: 9.1Level: HLGTClassification code 10011082

Registration Number: EUCTR2009-010842-67-IT

Lead Sponsor: OSPEDALE G.PASQUINUCCI-FONDAZIONE TOSCANA GABRIELE MONASTERIO

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

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

1.acute myocardial infarction (< 3 months);
2.unstable angina;
3.any increase in CK-MB, troponin I, or myoglobin above upper normal limit at the time of randomization;
4.any increase in liver enzymes (AST/ALT);
5.left ventricular ejection fraction <30%
6.renal failure with creatinine >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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures