Effects of eicosapentaenoic acid on cardiovascular events in Japanese high risk patients
Phase 4
Recruiting
- Conditions
- Cardiovascular disease
- Registration Number
- JPRN-UMIN000007266
- Lead Sponsor
- Kanagawa Cardiovascular and Respiratory Center
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
1)Acute myocardial infarction occurring within last 6 months 2)Unstable angina pectoris 3)Patinets intending to undergo interventions 4)A history or complication of serious heart disease (sever arrhythmia, heart failure, cardio myopathy, vascular diease, congenital heart diease,etc) 5)Receiving cardiovascular reconstructions within last 6 months 6)Complications of serious hepatic disease or renal disease 7)Malignant tumor 8)Uncontrollable diabetes 9)Familial hyperlipidemia 10)Hemorrage 11)Hypersensitivity to the study drug formulation 12)Patients intending undergo surgery 13)Patients judged to be inappropriate by the physician in charge
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Combined end point of cardiovascular death, nonfatal MI , vascular interventions , hospitalizations for ischemic events, nonfatal stroke
- Secondary Outcome Measures
Name Time Method 1.All causes death 2.Cardiovascular death 3. Fatal or nonfatal MI 4 Hospitalizations for ischemic events 5. Coronary interventions 6. Fatal or nonfatal stroke 7. Hospitalizations for congestive heart failure 8. Vascular interventions 9. the change of the eicosapentanoic/ arachidonic acid ratio at baseline and follow-up 10. Adverse events : Life-threatening bleeding and Major bleeding and Minor bleeding