Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia (STRENGTH)
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
About this trial
This is an interventional treatment trial for Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD) focused on measuring omega-3 carboxylic acid
Eligibility Criteria
Inclusion Criteria:
- Men or women, ≥18 years of age.
Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- LDL-C <100 mg/dL
- TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
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:
- Any atherosclerotic CVD as defined in protocol.
- 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.
- 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.
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Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
EPANOVA
Corn oil
Epanova + statin, once daily
Corn oil + Statin