Prognostic effects of eicosapentaenoic acid (EPA) in patients with atherosclerotic diseases
- Conditions
- Patients with atherosclerotic diseases
- Registration Number
- JPRN-UMIN000012852
- Lead Sponsor
- ational hospital organization Minamiwakayama Medical Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 100
Not provided
Patients who meet one of the following criteria; (1) Patients on dialysis (2) Patients with serious hepatic disease (3) Patients with active malignant tumor (4) Patients for whom coronary angiography or coronary revascularization is scheduled but not yet conducted (5) Patients with severe heart failure (NYHA class 3 or 4 according to NYHA classification) (6) Patients who experienced acute coronary syndrome (acute myocardial infarction or unstable angina) within three month at the time of informed consent (7) Patients who received coronary revascularization (PCI or CABG) within three month at the time of informed consent (8) Patients with inadequately controlled diabetes mellitus[HbA1c (JDS): 8.0% or more, HbA1c (NGSP): 8.4% or more] (9) Patients with secondary dyslipidemia associated with (a) nephrotic syndrome, (b) hypothyroidism, (c) Cushing syndrome and (d) other diseases, patients with drug-induced dyslipidemia such as that caused by steroid hormone, or patients receiving EPA (including OTC drugs) or EPA/DHA, or having received such drug within previous 1 month at the time of informed consent (10) Patients having active bleeding or bleeding tendency (11) Patients with a history of adverse reaction to EPA (12) Patients participating in other clinical trial (13) Pregnant women, possibly pregnant women, or women during lactation (14) Other patients who, in the opinion of the participating physician, are not eligible
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary endpoints are the first occurrence of any of the following cardiovascular events. All cause death, cardiovascular death, non-fatal myocardial infarction (MI)*, non-fatal stroke, coronary artery bypass grafting (CABG), and resuscitation from cardiac arrest. * indicates not including percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) related MI.
- Secondary Outcome Measures
Name Time Method