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

Phase 3

Completed

• Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
• Interventions: Drug: Epanova® (omega-3 carboxylic acids); Drug: corn oil control

• Registration Number: NCT02104817
• Lead Sponsor: AstraZeneca

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-04-02
• Study First Submitted QC: 2014-04-02
• Study First Posted: 2014-04-04
• Study Start: 2014-10-30
• Primary Completion: 2020-05-27
• Study Completion: 2020-05-27
• Results First Submitted: 2021-05-25
• Results First Submitted QC: 2021-07-08
• Results First Posted: 2021-07-28
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-16
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 13078

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EPANOVA	Epanova® (omega-3 carboxylic acids)	Epanova + statin, once daily
Corn oil	corn oil control	Corn oil + Statin

Primary Outcome Measures

Name	Time	Method
The Composite of Major Adverse Cardiovascular Events (MACE)	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 Outcome Measures

Name	Time	Method
The Composite of Coronary Events 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	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
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (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 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).
CV Death	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.
All-cause 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	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
The Composite of CV Events	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).
The Composite of Coronary Events	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).
All-cause Death	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.
CV 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	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
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline	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).

Trial Locations

Locations (1)

Research Site; 🇬🇧 Torquay, United Kingdom