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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 : Active, not recruiting
First Posted : April 4, 2014
Last Update Posted : February 7, 2020
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 : 13086 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
Estimated Primary Completion Date : May 15, 2020
Estimated Study Completion Date : May 15, 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 primary outcome measure is the time to the first occurrence of any component of the composite of MACE. [ Time Frame: Patients will remain in the study until the required number of MACE has occurred. We anticipate that patients will be in the study for up to 5 years. ]
    MACE components include: cardiovascular death, nonfatal MI, nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina.


Secondary Outcome Measures :
  1. The composite measure of CV events that include the first occurrence of cardiovascular death, non-fatal MI and non-fatal stroke. [ Time Frame: We anticipate that patients will be in the study for up to 5 years. Same for all outcome measures. ]
    The secondary outcome measures will be analyzed the same as outlined above for the primary outcome measures.

  2. The composite measure of coronary events that include the first occurrence of cardiac death. [ Time Frame: Up to 5 years ]
    The composite measure of coronary events that include the first occurrence of cardiac death ( including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), nonfatal MI, emergent/elective coronary revascularization, or hospitalization for unstable angina.

  3. The first occurrence of individual components of MACE: cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. [ Time Frame: Up to 5 years ]
  4. Time to CV death [ Time Frame: Up to 5 years ]
    Cardiovascular death includes death resulting from: an acute MI, sudden cardiac death, death due to heart failure (HF), death due to stroke, death due to cardiovascular (CV) procedures, death due to CV hemorrhage, and death due to other CV causes.


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
More Information
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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
Last Update Posted: February 7, 2020
Last Verified: February 2020
Keywords provided by AstraZeneca:
omega-3 carboxylic acid
Additional relevant MeSH terms:
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Atherosclerosis
Hypertriglyceridemia
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Arteriosclerosis
Arterial Occlusive Diseases
 Vascular Diseases
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Enzyme Inhibitors
Lipid Regulating Agents