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

NCT02104817 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 13078

Last updated 2021-08-17

Study results available
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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.

Conditions

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

Interventions

DRUG

Epanova® (omega-3 carboxylic acids)

Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)

DRUG

corn oil control

corn oil control arm

Sponsors & Collaborators

  • The Cleveland Clinic

    collaborator OTHER

  • IQVIA RDS Inc.

    collaborator INDUSTRY

  • AstraZeneca

    lead INDUSTRY

Principal Investigators

  • Steven Nissen, MD · The Cleveland Clinic

  • Michael Lincoff, MD · The Cleveland Clinic

  • Stephen Nicholls, MD · MonashHeart

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
99 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-30
Primary Completion
2020-05-27
Completion
2020-05-27

Countries

  • United States
  • Australia
  • Belgium
  • Canada
  • China
  • Czechia
  • Denmark
  • Estonia
  • Hungary
  • Italy
  • Japan
  • Lithuania
  • Mexico
  • Netherlands
  • New Zealand
  • Poland
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104817 on ClinicalTrials.gov