A RANDOMIZED MULTICENTRE PHASE II STUDY TESTING TOLERABILITY AND EFFICACY ON SURROGATE ENDPOINTS (LIPID PROFILE, VASCULAR INFLAMMATORY MARKERS AND THROMBOGENESIS) OF SIMVAPUFA FORMULATION (ASSOCIATION OF SIMVASTATIN AND OMEGA-3 FATTY ACIDS) IN COMPARISON WITH THE ADMINISTRATION OF THE TWO SEPARATE COMPOUNDS, IN PATIENTS WITH ACUTE CORONARY SYNDROME AND POSITIVE BIOCHEMICAL MARKERS OF MYOCARDIAL NECROSIS. - Simva Pufa
- Conditions
- 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)
- Registration Number
- EUCTR2007-005582-36-IT
- Lead Sponsor
- DEFIANTE FARMACEUTICA,LDA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
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
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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method