Skip to main content
OpenTrials
Completed

NCT Number: NCT02104817

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Adelaide, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:

  • 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.

Treatment and study plan

Epanova® (omega-3 carboxylic acids)

Drug

Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)

Other names: omega-3 carboxylic acids

corn oil control

Drug

corn oil control arm

Primary outcomes

  1. The Composite of Major Adverse Cardiovascular Events (MACE)

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Secondary outcomes

  1. The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  2. The Composite of CV Events

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  3. The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  4. The Composite of Coronary Events

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  5. The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline

  6. CV Death

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.

  7. CV Death in the Subgroup of Participants With Established CVD at Baseline

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline

  8. All-cause Death

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.

  9. All-cause Death in the Subgroup of Participants With Established CVD at Baseline

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline

Other outcomes

  1. Emergent/Elective Coronary Revascularization

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  2. Hospitalization for Unstable Angina

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  3. Non-fatal Myocardial Infarction

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

  4. Non-fatal Stroke

    Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

    Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Collaborators

  • IQVIA RDS Inc.
  • The Cleveland Clinic

Registry information

Official study title

A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)

Acronym: STRENGTH

Important dates

Study start
2014
Primary completion
2020
Study completion
2020
First posted
Apr 4, 2014
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.