Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (EVAPORATE)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02926027 |
Recruitment Status :
Completed
First Posted : October 6, 2016
Results First Posted : November 2, 2021
Last Update Posted : November 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hypertriglyceridemia | Drug: Vascepa Drug: placebo | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 80 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy |
Actual Study Start Date : | March 28, 2017 |
Actual Primary Completion Date : | May 15, 2020 |
Actual Study Completion Date : | August 15, 2020 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Active subjects
Vascepa (4 gm/day), oral dose
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Drug: Vascepa
Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid. |
Placebo Comparator: Placebo subject
oral dose of placebo
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Drug: placebo
placebo |
- 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
- 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.

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Ages Eligible for Study: | 30 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02926027
United States, California | |
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute) | |
Torrance, California, United States, 90502 | |
United States, Utah | |
Intermountain Medical Center, Intermountain Heart Institute | |
Murray, Utah, United States, 84157 |
Principal Investigator: | Matthew Budoff, MD | Lundquist Institute for Biomedical Innovation (The Lundquist Institute) |
Documents provided by Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center:
Responsible Party: | Matthew J. Budoff, Principal Investigator, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center |
ClinicalTrials.gov Identifier: | NCT02926027 |
Other Study ID Numbers: |
21733-01 |
First Posted: | October 6, 2016 Key Record Dates |
Results First Posted: | November 2, 2021 |
Last Update Posted: | November 2, 2021 |
Last Verified: | October 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Data will be tabulated and analysed. Study site will not share any of the subject identifiers. |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Atherosclerosis Coronary Artery Disease Myocardial Ischemia Hypertriglyceridemia Arteriosclerosis Arterial Occlusive Diseases Vascular Diseases Cardiovascular Diseases Hyperlipidemias |
Dyslipidemias Lipid Metabolism Disorders Metabolic Diseases Coronary Disease Heart Diseases Eicosapentaenoic acid ethyl ester Platelet Aggregation Inhibitors Lipid Regulating Agents |