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

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ClinicalTrials.gov Identifier: NCT02926027
Recruitment Status : Recruiting
First Posted : October 6, 2016
Last Update Posted : October 16, 2018
Sponsor:
Collaborator:
Intermountain Research and Medical Foundation
Information provided by (Responsible Party):
Matthew J. Budoff, Los Angeles Biomedical Research Institute

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.

Condition or disease Intervention/treatment Phase
Hypertriglyceridemia Drug: Vascepa Drug: placebo Not Applicable

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  (Clinical Trial)
Estimated 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
Study Start Date : September 2016
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019


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

Placebo Comparator: Placebo subject
oral dose of placebo
Drug: placebo
placebo




Primary Outcome Measures :
  1. Progression rates of low attenuation plaque under influence of Vascepa as compared to placebo. [ Time Frame: 18 months ]

Secondary Outcome Measures :
  1. The morphology of non-calcified coronary atherosclerotic plaque (NCP) [ Time Frame: 18 months ]
  2. markers of inflammation (Lp-PLA2) [ Time Frame: 18 months ]
    changes in markers of inflammation

  3. changes in markers of LDL and HDL cholesterol [ Time Frame: 18 months ]
    changes in markers of cholesterol

  4. The composition of non-calcified coronary atherosclerotic plaque (NCP) [ Time Frame: 18 months ]


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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
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

Information from the National Library of Medicine

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


Contacts
Contact: Sajad Hamal, MS 310-974-9336 shamal@labiomed.org
Contact: Matthew Budoff, MD 310-222-4107 mbudoff@labiomed.org

Locations
United States, California
Los Angeles Biomedical Research Institute Recruiting
Torrance, California, United States, 90502
Contact: Matthew Budoff, MD    310-222-4107    mbudoff@labiomed.org   
Contact: Sajad Hamal, MS    310-974-9336    shamal@labiomed.org   
Principal Investigator: Matthew J Budoff, MD         
United States, Utah
Intermountain Medical Center, Intermountain Heart Institute Recruiting
Murray, Utah, United States, 84157
Contact: J B Muhlestein, MD    801-507-4701    JBrent.Muhlestein@imail.org   
Contact: Patti Spencer, BS    801-507-4778    patti.spencer@imail.org   
Principal Investigator: J B Muhlestein, MD         
Sponsors and Collaborators
Los Angeles Biomedical Research Institute
Intermountain Research and Medical Foundation
Investigators
Principal Investigator: Matthew Budoff, MD Los Angeles Biomedical Research Institute (LABioMed)

Responsible Party: Matthew J. Budoff, Principal Investigator, Los Angeles Biomedical Research Institute
ClinicalTrials.gov Identifier: NCT02926027     History of Changes
Other Study ID Numbers: 21733-01
First Posted: October 6, 2016    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018
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.

Additional relevant MeSH terms:
Platelet Aggregation Inhibitors
Atherosclerosis
Hypertriglyceridemia
Coronary Artery Disease
Myocardial Ischemia
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
Metabolic Diseases
Coronary Disease
Heart Diseases
Eicosapentaenoic acid ethyl ester