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

NCT ID: NCT02926027

Last Updated: 2023-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-28
• Study Completion Date: 2020-08-15

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).

Conditions

Hypertriglyceridemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Active subjects

Vascepa (4 gm/day), oral dose

Group Type: ACTIVE_COMPARATOR

Vascepa

Intervention Type: DRUG

Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.

Placebo subject

oral dose of placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

placebo

Interventions

Vascepa

Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.

Intervention Type: DRUG

placebo

placebo

Intervention Type: DRUG

Other Intervention Names

icosapent ethyl

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Intermountain Research and Medical Foundation

OTHER

Sponsor Role: collaborator

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Matthew J. Budoff

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Matthew Budoff, MD

Role: PRINCIPAL_INVESTIGATOR

Lundquist Institute for Biomedical Innovation (The Lundquist Institute)

Locations

Lundquist Institute for Biomedical Innovation at Harbor UCLA Medical Center (The Lundquist Institute)

Torrance, California, United States

Intermountain Medical Center, Intermountain Heart Institute

Murray, Utah, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

21733-01

Identifier Type: -

Identifier Source: org_study_id