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Active Clinical Trials


Active NCT:
Tri CountyCardiology in Lower Burrel
Tri CountyCardiology in Lower Burrel

Tri CountyCardiology in Natrona Heights
Tri CountyCardiology in Natrona Heights

Allegheny Valley Hospital
Allegheny Valley Hospital

AstraZeneca, (originally Omthera)

For more information, please contact Cheryl Helgert at 724-226-7460 or

AB, D5881C00004, STRENGTH: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction with EpaNova in HiGh Cardiovascular Risk PatienTs with Hypertriglyceridemia


The study is a randomized, double-blind, well-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia 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.

Ages Eligible for Study: 18 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

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:
  1. LDL-C <100 mg/dL
  2. TG level≥ 200 and < 500 mg/dL and HDL-C < 40 mg/dL for men or HDL-C < 45 mg/dL for women
  • 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:


  • 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.