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

AstraZeneca13,078 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

13,078

Conditions

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

Interventions

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)

corn oil controlDRUG

corn oil control arm

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Men or women, ≥18 years of age. 2. Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria: 1. LDL-C \<100 mg/dL 2. TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 mg/dL for women 3. 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: 1. Any atherosclerotic CVD as defined in protocol. 2. 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. 3. 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.

Locations (684)

Outcomes

Primary Outcomes

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).

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

Secondary Outcomes

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

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).

Time frame: 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

Data from ClinicalTrials.gov

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Research Site

Birmingham, Alabama, United States

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

...and 674 more locations

Time frame: 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).

Time frame: 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

Time frame: 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.

Time frame: 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

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

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

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

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