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

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ClinicalTrials.gov Identifier: NCT02104817
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : July 28, 2021
Last Update Posted : August 17, 2021
Sponsor:
Collaborators:
The Cleveland Clinic
IQVIA RDS Inc.
Information provided by (Responsible Party):
AstraZeneca

Study Description
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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.

Condition or disease Intervention/treatment Phase
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD) Drug: Epanova® (omega-3 carboxylic acids) Drug: corn oil control Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 13078 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
Actual Study Start Date : October 30, 2014
Actual Primary Completion Date : May 27, 2020
Actual Study Completion Date : May 27, 2020

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Arms and Interventions
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Arm Intervention/treatment
Experimental: EPANOVA
Epanova + statin, once daily
 Drug: Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Other Name: omega-3 carboxylic acids
Active Comparator: Corn oil
Corn oil + Statin
 Drug: corn oil control
corn oil control arm


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104817


Locations
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Sponsors and Collaborators
AstraZeneca
The Cleveland Clinic
IQVIA RDS Inc.
Investigators
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Principal Investigator: Steven Nissen, MD The Cleveland Clinic
Principal Investigator: Michael Lincoff, MD The Cleveland Clinic
Principal Investigator: Stephen Nicholls, MD MonashHeart
  Study Documents (Full-Text)

Documents provided by AstraZeneca:
Study Protocol  [PDF] May 1, 2015
Statistical Analysis Plan  [PDF] April 22, 2020

More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT02104817    
Other Study ID Numbers: D5881C00004
2014-001069-28 ( EudraCT Number )
First Posted: April 4, 2014    Key Record Dates
Results First Posted: July 28, 2021
Last Update Posted: August 17, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description:

Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.

Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
URL: https://astrazenecagroup-dt.pharmacm.com/DT/Home
Keywords provided by AstraZeneca:
omega-3 carboxylic acid
Additional relevant MeSH terms:
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Cardiovascular Diseases
Atherosclerosis
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
 Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases