E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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 Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10057787 |
|
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10011082 |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
impact of atorvastatin treatment on sLOX-1 serum levels, from the time of treatment initiation until 6 months of follow-up. |
|
E.2.2 | Secondary objectives of the trial |
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 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
|
E.4 | Principal 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 |
|
E.5 End points |
E.5.1 | Primary end point(s) |
effects of atorvastatin treatment on sLOX-1 levels , from the begining of treatment upto 6 months follow-up |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 12 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 12 |