An Outcomes Study to Assess Statin Residual Risk Reduction with Epanova in High Cardiovascular Risk Patients with Hypertriglyceridemia

Overview

About this study

The purpose of this study is to evaluate the effectiveness of adding epanova to statin therapy for lowering major adverse cardiovascular events in high cardiovascular risk patients with hypertriglyceridemia.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria

  • Men or women
  • ≥18 years of age
  • Must be on a stable diet and statin therapy at least 4 weeks prior to randomization (visit 2) 
  • Must meet the following criteria
    • LDL-C <100 mg/dL
    • TG level ≥180 and <500 mg/dL 
    • HDL-C <42 mg/dL for men 
    • HDL-C <47 mg/dL for women
  • At high risk for a future cardiovascular event
  • At least one of the following criteria is present via patient history, physical exam, or medical records at the time of screening
    • Any atherosclerotic cardiovascular disease 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

 

Exclusion Criteria

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

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

La Crosse, Wis.

Mayo Clinic principal investigator

Tahir Tak, M.D., Ph.D.

Closed for enrollment

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

Additional contact information

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Phone: 800-664-4542 (toll-free)

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