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)
Conditions
Interventions
Trade Name: ESKIM
Pharmaceutical Form: Tablet
INN or Proposed INN: Omega-3-triglycerides
Concentration unit: g gram(s)
Concentration type: equal
Concentration number: 1-
Product Name: Simvapufa
Pharm
Sponsors
DEFIANTE FARMACEUTICA,LDA
Eligibility
Sex/Gender
All
Inclusion criteria
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. 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: Enrolment Exclusion Criteria #61623; Congestive Heart Failure (NYHA Class #8805; 2) and/or depressed left ventricular function (LVEF 1.5 the upper normal limit. #61623; CPK level above the upper limit of normality #61623; Renal failure (Serum creatinine > 2.5 mg/dl).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.;Secondary Objective: 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;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. | — |
Countries
Italy
Outcome results
None listed