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

Primary Purpose

Hypertriglyceridemia

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Vascepa
placebo
Sponsored by
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertriglyceridemia

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
  • Intermountain Medical Center, Intermountain Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Active subjects

Placebo subject

Arm Description

Vascepa (4 gm/day), oral dose

oral dose of placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
the measure is reported as volume of non-calcified plaque, as the secondary measure has been reported.

Full Information

First Posted
September 28, 2016
Last Updated
February 17, 2023
Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Intermountain Research and Medical Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02926027
Brief Title
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
Acronym
EVAPORATE
Official Title
Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
March 28, 2017 (Actual)
Primary Completion Date
May 15, 2020 (Actual)
Study Completion Date
August 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Collaborators
Intermountain Research and Medical Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertriglyceridemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active subjects
Arm Type
Active Comparator
Arm Description
Vascepa (4 gm/day), oral dose
Arm Title
Placebo subject
Arm Type
Placebo Comparator
Arm Description
oral dose of placebo
Intervention Type
Drug
Intervention Name(s)
Vascepa
Other Intervention Name(s)
icosapent ethyl
Intervention Description
Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo
Primary Outcome Measure Information:
Title
Progression Rates of Low Attenuation Plaque Under Influence of Vascepa as Compared to Placebo as a Change Between Two or More Time Points
Description
low attenuation plaque volume change from baseline to 18 months
Time Frame
18 months
Secondary Outcome Measure Information:
Title
The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
Description
the measure is reported as volume of non-calcified plaque, as the secondary measure has been reported.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthew Budoff, MD
Organizational Affiliation
Lundquist Institute for Biomedical Innovation (The Lundquist Institute)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Intermountain Medical Center, Intermountain Heart Institute
City
Murray
State/Province
Utah
ZIP/Postal Code
84157
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be tabulated and analysed. Study site will not share any of the subject identifiers.

Learn more about this trial

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

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