- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02926027
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy (EVAPORATE)
February 17, 2023 updated by: Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
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
Conditions
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
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Torrance, California, United States, 90502
- Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
-
-
Utah
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Murray, Utah, United States, 84157
- Intermountain Medical Center, Intermountain Heart Institute
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-
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:
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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.
Collaborators
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
Additional Relevant MeSH Terms
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Metabolic Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Lipid Metabolism Disorders
- Hyperlipidemias
- Dyslipidemias
- Coronary Artery Disease
- Myocardial Ischemia
- Atherosclerosis
- Hypertriglyceridemia
- Platelet Aggregation Inhibitors
- Lipid Regulating Agents
- Eicosapentaenoic acid ethyl ester
Other Study ID Numbers
- 21733-01
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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