Phase 3
Completed N=13,078
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Source: ClinicalTrials.gov NCT02104817 ↗
Enrolled (actual)
13,078
Serious AEs
34.1%
Results posted
Jul 2021
Primary outcomePrimary: The Composite of Major Adverse Cardiovascular Events (MACE) — 785; 795 Number of Participants — p=0.837
◆ Published Evidence
Highly cited
977citations · ~163 / year
Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.
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.
Linked Publications (2)
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Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial.
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Association Between Achieved ω-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk: A Secondary Analysis of the STRENGTH Trial.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Composite of Major Adverse Cardiovascular Events (MACE) |
785; 795 | 0.837 |
| SECONDARY The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline |
785; 795; 569; 610 | 0.269 |
| SECONDARY The Composite of CV Events |
541; 517 | 0.402 |
| SECONDARY The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline |
541; 517; 383; 385 | 0.940 |
| SECONDARY The Composite of Coronary Events |
556; 616 | 0.092 |
| SECONDARY The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline |
556; 616; 417; 493 | 0.016 sig |
| SECONDARY CV Death |
228; 211 | 0.372 |
| SECONDARY CV Death in the Subgroup of Participants With Established CVD at Baseline |
228; 211; 152; 138 | 0.336 |
| SECONDARY All-cause Death |
373; 333 | 0.112 |
| SECONDARY All-cause Death in the Subgroup of Participants With Established CVD at Baseline |
373; 333; 234; 202 | 0.091 |
Eligibility Criteria
Inclusion Criteria
- Men or women, ≥18 years of age.
- Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
- LDL-C 50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.
Key Exclusion Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT02104817) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.