Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design
 that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high
 risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once
 daily, for approximately 3-5 years as determined when the number of MACE outcomes is reached.
Inclusion Criteria:

 1. Men or women, ≥18 years of age.

 2. Patient must be on a stable diet and statin* therapy at least 4 weeks prior to
 randomization (Visit 2) and meet the following criteria:

 1. LDL-C <100 mg/dL

 2. TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for
 women

 3. Patient is at high risk for a future cardiovascular event if at least one of the
 following criteria (3a, 3b or 3c)* is present via patient history, physical exam, or
 medical records at the time of screening:

 1. Any atherosclerotic CVD as defined in protocol.

 2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50
 years of age for women, plus one of the risk factors defined in protocol.

 3. Male patients >50 years of age or females >60 years of age, with at least one of
 the risk factors defined in protocol.

 Key Exclusion Criteria:

 1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid
 ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its
 analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.