HypertriglyceridemiaPhase 4EVAPORATENCT02926027
Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
A Phase 4 study testing Vascepa in people with Hypertriglyceridemia, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 85 years
- Conditions the study is for
- Hypertriglyceridemia
- What is being tested?
- Vascepa
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 28 Mar 2017to 15 Aug 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Intermountain Medical Center, Intermountain Heart Institute
Murray, Utah, 84157
Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)
Torrance, California, 90502
About this study
Official title: 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.
Read the 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).
- Conditions
- Hypertriglyceridemia
- Being tested
- Vascepa, placebo
- Medical subject headings
- Hypertriglyceridemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VascepaDrug
Also called icosapent ethyl
Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.
placeboDrug
placebo
| Study group | Role | What they receive |
|---|---|---|
| Active subjects | Active comparator | Vascepa (4 gm/day), oral dose Receives: Drug: Vascepa |
| Placebo subject | Placebo comparator | oral dose of placebo Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 18 months
Secondary outcomes (1)
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study start28 Mar 2017
- Primary completion15 May 2020
- Study completion15 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertriglyceridemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Responsible party
- Principal investigator, Matthew J. Budoff, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
- Investigators
- Matthew Budoff, MD, Principal investigator, Lundquist Institute for Biomedical Innovation (The Lundquist Institute)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02926027
- Sponsor's protocol ID
- 21733-01
- Acronym
- EVAPORATE
- Status last verified
- Feb 2023
- First submitted
- 28 Sep 2016
- Last updated
- 21 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be tabulated and analysed. Study site will not share any of the subject identifiers.
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Vascepa on Progression of Coronary Atherosclerosis in Persons With Elevated Triglycerides (200-499) on Statin Therapy
- ClinicalTrials.gov ID
- NCT02926027
- Acronym / sponsor ID
- EVAPORATE / 21733-01
- Conditions
- Hypertriglyceridemia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical CenterUniversity, hospital or other
- Collaborators
- Intermountain Research and Medical Foundation
- Study start
- 28 Mar 2017 (actual)
- Primary completion
- 15 May 2020 (actual)
- Study completion
- 15 Aug 2020 (actual)
- First posted
- 6 Oct 2016 (estimated)
- Results
- Posted 2 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active subjects | Active comparator | Drug: VascepaVascepa (4 gm/day), oral dose |
| Placebo subject | Placebo comparator | Drug: placebooral dose of placebo |
Who may qualify
- Ages
- 30 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VascepaAlso: icosapent ethylVascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid. | Drug | Active subjects |
| placeboplacebo | Drug | Placebo subject |
Primary outcome
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
1 secondary outcome
The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be tabulated and analysed. Study site will not share any of the subject identifiers.
Related trials for Hypertriglyceridemia
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A Study of Solbinsiran (LY3561774) in Participants With Severe Hypertriglyceridemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthew Budoff, MD principal investigator
Lundquist Institute for Biomedical Innovation (The Lundquist Institute)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Vascepa in people with Hypertriglyceridemia, run by Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.