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

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Drug: Epanova® (omega-3 carboxylic acids)
* Drug: corn oil control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: EPANOVA<br>Epanova + statin, once daily | Drug: Epanova® (omega-3 carboxylic acids)<br>* Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)<br>* Other names: omega-3 carboxylic acids;|
| Active Comparator: Corn oil<br>Corn oil + Statin | Drug: corn oil control<br>* corn oil control arm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite of Major Adverse Cardiovascular Events (MACE) | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| The Composite of CV Events | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| The Composite of Coronary Events | 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). | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline | 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| CV Death | 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. | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| CV Death in the Subgroup of Participants With Established CVD at Baseline | 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| All-cause Death | 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. | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 
| All-cause Death in the Subgroup of Participants With Established CVD at Baseline | 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 | From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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omega-3 carboxylic acid