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

• ClinicalTrials.gov Identifier: NCT02104817
• Recruitment Status: Active, not recruiting
• First Posted: April 4, 2014
• Last Update Posted: August 15, 2019
• Sponsor: AstraZeneca
• Collaborators: The Cleveland Clinic; Quintiles, Inc.
• Information provided by (Responsible Party): AstraZeneca

Study Description

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

• 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: September 30, 2020
• Estimated Study Completion Date: September 30, 2020

Arms and Interventions

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

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

• 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

  Show 629 Study Locations

Sponsors and Collaborators

AstraZeneca

The Cleveland Clinic

Quintiles, Inc.

Investigators

• Principal Investigator: Steven Nissen, MD; The Cleveland Clinic
• Principal Investigator: Michael Lincoff, MD; The Cleveland Clinic
• Principal Investigator: Stephen Nicholls, MD; Adelaide Clinical Research

More Information

• Responsible Party: AstraZeneca
• ClinicalTrials.gov Identifier: NCT02104817 History of Changes
• Other Study ID Numbers: D5881C00004; 2014-001069-28 ( EudraCT Number )
• First Posted: April 4, 2014
• Last Update Posted: August 15, 2019
• Last Verified: August 2019

Keywords provided by AstraZeneca:

omega-3 carboxylic acid

Additional relevant MeSH terms:

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