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Active Clinical Trials

STRENGTH

Active NCT:
02104817
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

Sponsor: 
AstraZeneca, (originally Omthera)
Contact: 

For more information, please contact Cheryl Helgert at 724-226-7460 or Cheryl.Helgert@ahn.org

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

Purpose: 

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.