Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia

Completed · Phase 3

Conditions studied: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)

In brief

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.

Key facts

Study ID

NCT02104817

Run by

AstraZeneca

People needed

13078

Starts

2014-10-30

Expected to finish

2020-05-27

Last updated by the study team

2021-08-17

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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:
• 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.

Where it is running

• Research Site — Birmingham, Alabama, United States
• Research Site — Birmingham, Alabama, United States
• Research Site — Birmingham, Alabama, United States
• Research Site — Huntsville, Alabama, United States
• Research Site — Muscle Shoals, Alabama, United States
• Research Site — Chandler, Arizona, United States
• Research Site — Gilbert, Arizona, United States
• Research Site — Glendale, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Mesa, Arizona, United States
• Research Site — Phoenix, Arizona, United States
• Research Site — Tempe, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Tucson, Arizona, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Little Rock, Arkansas, United States
• Research Site — Carlsbad, California, United States
• Research Site — Fresno, California, United States
• Research Site — Fresno, California, United States
• Research Site — Greenbrae, California, United States
• Research Site — Long Beach, California, United States
• Research Site — Los Angeles, California, United States
• Research Site — Milpitas, California, United States
• Research Site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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