Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (EVAPORATE)

Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy

Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons with Elevated Triglycerides (200-499) on Statin Therapy. The study is to determine progression rates of low attenuation plaque under influence of Vascepa as compared to placebo.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Residual cardiovascular (CV) risk remains in dyslipidemic patients despite intensive statin therapy, underscoring the need for additional intervention. Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid, is incorporated into membrane phospholipids and atherosclerotic plaques and exerts beneficial effects on the pathophysiologic cascade from onset of plaque formation through rupture. EPA also improves atherogenic dyslipidemia characterized by reduction of triglycerides without raising low-density lipoprotein cholesterol. All of this data supports the biologic plausibility of EPA as an anti-atherosclerotic agent. The goal of this study is to evaluate whether treatment with Vascepa (4 grams) results in a greater change from baseline in low attenuation plaque than placebo in subjects with elevated triglycerides (200-499 mg/dl).

Study Type

Interventional

Enrollment (Actual)

80

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • California
      • Torrance, California, United States, 90502
        • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
    • Utah
      • Murray, Utah, United States, 84157
        • Intermountain Medical Center, Intermountain Heart Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Elevated triglycerides (fasting value between 200-499 mg/dl) at qualifying or baseline visit.
  • LDL-C ≤115 mg/dL on appropriate statin therapy
  • LDL-C >40 mg/dL
  • Stable diet and exercise, as defined as the same pattern for the previous 4 weeks
  • Stable treatment with a statin+/- ezetimibe for at least 4 weeks
  • Patients with at least 1 angiographic stenosis with at least 20% narrowing by coronary computed tomography angiography (CTA).
  • Willingness to be on birth control for women of childbearing age or established post-menopausal

Exclusion Criteria:

  • A contraindication to fish or fish oils including: known hypersensitivity to drug or fish.
  • Any unstable medical, psychiatric or substance abuse disorder that in the opinion of the investigator or principal investigator is likely to affect the subject's ability to complete the study or precludes the subject's participation in the study.
  • Non-study lipid altering medications or supplements (ie - Niacin, PCSK9, fibrates, bile acid Sequestrants, dietary fish oil supplement capsules, orlistat [OTC (Alli®) as well as Rx (Xenical®)] or other drugs used for weight loss).
  • Stable (same daily dose for the last 4 weeks) on medications that can affect lipids (retinoids, hormones, steroids, HIV medications, chemotherapy, thyroid medications).
  • BMI > 40
  • Bleeding disorder
  • Uncontrolled hypertension (SBP≥ 180 mmHg or DBP≥100 mmHg)
  • History of known myocardial infarction, stroke or life-threatening arrhythmia within the prior six months.
  • NYHA Class III- IV heart failure
  • History of malignancy within the last 5 years (other than skin cancer) or evidence of active cancer which would require concomitant cancer chemotherapy.
  • Serum creatinine > 1.4 mg/dl
  • Drug or alcohol abuse, or current intake of more than 14 ounces of alcohol per week for men and 10 ounces for women
  • Concurrent enrollment in another placebo-controlled trial or within 30 days of finishing another trial
  • Partial ileal bypass or known gastrointestinal disease limiting drug absorption
  • History of hypertensive encephalopathy or cerebrovascular accident
  • Hematological or biochemical values at screening outside the reference ranges considered as clinically significant in the opinion of the investigator or PI
  • Pregnancy
  • Genetic mutations/polymorphisms having an effect on blood lipids
  • History of coronary artery bypass surgery
  • Allergy to contrast material
  • Allergy to beta-blocker in subjects with resting heart rate >70 bpm

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Active subjects
Vascepa (4 gm/day), oral dose
Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
Other Names:
  • icosapent ethyl
Placebo Comparator: Placebo subject
oral dose of placebo
placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression Rates of Low Attenuation Plaque Under Influence of Vascepa as Compared to Placebo as a Change Between Two or More Time Points
Time Frame: 18 months
low attenuation plaque volume change from baseline to 18 months
18 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
Time Frame: 18 months
the measure is reported as volume of non-calcified plaque, as the secondary measure has been reported.
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Matthew Budoff, MD, Lundquist Institute for Biomedical Innovation (The Lundquist Institute)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 28, 2017

Primary Completion (Actual)

May 15, 2020

Study Completion (Actual)

August 15, 2020

Study Registration Dates

First Submitted

September 28, 2016

First Submitted That Met QC Criteria

October 4, 2016

First Posted (Estimate)

October 6, 2016

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be tabulated and analysed. Study site will not share any of the subject identifiers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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