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

AstraZeneca

Status and phase: Completed; Phase 3

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

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02104817

D5881C00004

2014-001069-28 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13,078 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

13,078 participants in 2 patient groups

EPANOVA

Experimental group

Description:

Epanova + statin, once daily

Treatment:

Drug: Epanova® (omega-3 carboxylic acids)

Corn oil

Active Comparator group

Description:

Corn oil + Statin

Treatment:

Drug: corn oil control