Omacor in Prevention of Cardiovascular Events in Patients Undergoing Chronic Hemodialysis

• Composite endpoint, including either of the following events:
• - Acute Myocardial Infarction
• - Angina Pectoris, leading to coronary investigation or intervention
• - Transient Cerebral Ischemia (TCI)
• - Apoplexia cerebri (stroke)
• - Peripheral Vascular disease, new symptoms or worsening of old symptoms
• - Death

• - Efficacy laboratory variables (lipids, adhesion molecules, other efficacy lab variables, data for S-LDL-c size)
• - Efficacy, fatty acid profile for phospholipids fraction
• - Efficacy: diet registration, fish score
• - Thrombosis and/or stenosis of dialysis graft
• - Effect on heart rate variability, substudy of 50 patients at baseline and after three months

The aim of this investigator initated study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Patients with renal failure have a high incidence of cardiovascular disease and increased premature mortality. Omega-3 polyunsaturated fatty acids from fish are known to have cardioprotective effects in subects with normal renal function. The aim of present study is to examine the effect of OMACOR (Omega-3-acid ethyl ester 90) on the incidence of cardiovascular events and mortality in patients undergoing chronic hemodialysis, who has previously experienced a cardiovascular event.

Design: A prospective, randomised, placebo controlled study. 2 year treatment period.

Inclusion Criteria:

• Males and females above 18 years of age
• Patients having been treated with chronic hemodialysis for at least 6 months

• Patients with documented cardiovascular disease, at least one of the following

  1. Angina pectoris
  2. Previous Acute myocardial infarction
  3. Previous PTCA/CABG or demonstated atheroclerosis after coronary angio
  4. Previous Transitory Cerebral Ischemia
  5. Previous Apoplexia Cerebri
  6. Symptoms of peripheral vascular disease
• Written informed consent

Exclusion Criteria:

• Active malignant disease, except basal cell carcinoma or spinocellular carcinoma
• Patients undergoing peritoneal dialysis
• Any condition associated with a risk of poor compliance, as judged by investigator
• Pregnant or breastfeeding
• Participation in other clinical studies involving treatment with drugs.

• Danish Heart Foundation
• The Danish Kidney Association
• North Jutland County