E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
For this study, patients with acute coronary syndrome STEMI (ST-Elevation Myocardial Infarction and NSTEMI (Non-ST-Elevation Myocardial Infarction), occurred within the previous 72 hours with positive biochemical marker of myocardial necrosis ( troponin or CK-MB) |
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MedDRA Classification |
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 |
The main objective of this study is to show the safety and tolerability of Simvapufa, a new fixed dose combination of Simvastatin and omega-3 fatty acids, administered to patients with acute coronary syndrome. |
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E.2.2 | Secondary objectives of the trial |
The secondary objective is to compare the effect of Simvapufa and extemporaneous combination of Simvastatin and omega-3 fatty acids on lipid metabolism, incorporation of omega-3 PUFA in red blood cell membranes, systemic inflammatory markers, vascular inflammation markers and thrombogenesis in patients with acute coronary syndrome |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
5.3.1 Enrolment Inclusion Criteria #61623; Capability of understanding the nature of the trial and willingness to participate as documented by signing the written informed consent form. #61623; Male or female patients aged between 18 and 75 years. #61623; Acute coronary syndrome STEMI and NSTEMI, with hospitalization occurred in the previous 72 hours and with positive biochemical marker of myocardial necrosis ( troponin or CK-MB) #61623; No indication for aggressive therapy with statins (simvastatin >40 mg/day) Randomization inclusion criteria #61623; Negative pregnancy test for women of childbearing potential only. #61623; Acute coronary syndrome (STEMI and NSTEMI) with positive biochemical marker of myocardial necrosis ( troponin or CK-MB) occurred in the previous 30 day. #61623; Previous treatment with simvastatin ( 20 or 40 mg) for at least 15 days during the run-in period. |
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E.4 | Principal exclusion criteria |
Enrolment Exclusion Criteria #61623; Congestive Heart Failure (NYHA Class #8805; 2) and/or depressed left ventricular function (LVEF < 35%) documented by an echocardiogram performed during the hospitalisation. #61623; Coronary Artery By-pass Grafting in the previous 6 months.. #61623; Percutaneous Transluminal Coronary Angioplasty during the hospitalization performed without stent insertion #61623; Surgery or CABG (Coronary Artery Bypass Graft) or PTCA (Percutanueous Transluminal Coronary Angioplasty) planned during the study period. #61623; Patient under treatment with omega-3 PUFA #61623; Presence of atrial fibrillation #61623; On going infectious or inflammatory diseases. #61623; Known allergy or intolerance to one of the study drug. #61623; Chronic concomitant treatment with corticosteroids or NSAID (only low dose (maximum 100 mg) acetyl salicylic acid will be allowed). #61623; Pregnant or nursing women, or women of childbearing potential not taking anticontraceptive medication (from the previous 3 months and agreeing to continue during all the study period) or not utilising intra-uterine devices. #61623; Patient having a diagnosis or under investigation for a cancer or a chronic inflammatory disease. #61623; Patient not agreeing to avoid grapefruit consumption during the all study period. #61623; Any other clinically significant laboratory or medical condition, which in the opinion of the Investigator make the patient unsuitable for evaluation in the study. Randomization Exclusion Criteria #61623; Patient under treatment with anticoagulant therapies #61623; Liver disease (SGOT or SGPT levels > 1.5 the upper normal limit. #61623; CPK level above the upper limit of normality #61623; Renal failure (Serum creatinine > 2.5 mg/dl). |
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E.5 End points |
E.5.1 | Primary end point(s) |
All the efficacy end-points are analytical evaluations performed on biological samples (plasma and urine). Two different central laboratories will perform such determinations and the central laboratories will be blinded in term of patients treatment. In order to reduce intra-patient variability, run-in samples and end of study samples will be analyzed in the same analytical session, where stability of the analytes will allow that. #61623; Traditional markers of lipid metabolism: Total cholesterol, HDL-Cholesterol, LDL-cholesterol, VLDL-cholesterol, APO B and APO A1, Triglycerides, #61623; Systemic inflammatory markers: C-reactive protein (high sensitivity method) #61623; Serum glucose, insulin. #61623; EPA and DHA levels in plasma and red blood cell membranes. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Information not present in EudraCT |
E.6.2 | Prophylaxis | Information not present in EudraCT |
E.6.3 | Therapy | Information not present in EudraCT |
E.6.4 | Safety | Information not present in EudraCT |
E.6.5 | Efficacy | Information not present in EudraCT |
E.6.6 | Pharmacokinetic | Information not present in EudraCT |
E.6.7 | Pharmacodynamic | Information not present in EudraCT |
E.6.8 | Bioequivalence | Information not present in EudraCT |
E.6.9 | Dose response | Information not present in EudraCT |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Information not present in EudraCT |
E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
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 | Yes |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
stessi farmaci in diversa associazione |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 7 |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |