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STRENGTH

A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia

Objective

Status Enrollment Complete

Condition Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)

Description

Eligible Men or Women Considered High Risk   for Atherosclerotic Cardiovascular Disease (CVD)

Drug: Epanova® (omega-3 carboxylic acids)
Drug: corn oil control

Purpose

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.

Phase III

Key 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:
    • LDL-C <100 mg/dL or LDL – C > 100 mg/dL under certain circumstances
    • 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:
    • Any atherosclerotic CVD as defined in protocol.
    • 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.
    • 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.  Potential patients may not be       interested if they are on one of these medications since the washout       allowance is not mentioned

3. Statin naïve at Visit 1.

4. Patients on dialysis.

ClinicalTrials.gov Identifier

NCT02104817

Protocol Number

D5881C00004 

Principal Investigator(s)
Rabeea Aboufakher, MD

Clinical Trial Categories

  • Cardiology
Sponsor(s)
AztraZeneca
Contact
Brenda Westacott, CCRC at 701-780-1845
or bwestacott@altru.org