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

NCT02926027 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 21733-01
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypertriglyceridemia

Outcome Measures

Primary Outcomes (1)

• 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

  18 months

Secondary Outcomes (1)

• The Composition of Non-calcified Coronary Atherosclerotic Plaque (NCP)

  18 months

Study Arms (2)

Active subjects

ACTIVE COMPARATOR

Vascepa (4 gm/day), oral dose

Drug: Vascepa

Placebo subject

PLACEBO COMPARATOR

oral dose of placebo

Drug: placebo

Interventions

Vascepa DRUG

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

Also known as: icosapent ethyl

Active subjects

placebo DRUG

placebo

Placebo subject

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center: lead
• Intermountain Research and Medical Foundation: collaborator

Study Sites (2)

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

Torrance, California, 90502, United States

Location

Intermountain Medical Center, Intermountain Heart Institute

Murray, Utah, 84157, United States

Location

MeSH Terms

Conditions

Hypertriglyceridemia

Interventions

eicosapentaenoic acid ethyl ester

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Matthew Budoff
• Organization: Lundquist Institute

mbudoff@lundquist.org

3102224107

Study Officials

• Matthew Budoff, MD

  Lundquist Institute for Biomedical Innovation (The Lundquist Institute)

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 28, 2016
• First Posted: October 6, 2016
• Study Start: March 28, 2017
• Primary Completion: May 15, 2020
• Study Completion: August 15, 2020
• Last Updated: February 21, 2023
• Results First Posted: November 2, 2021

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share

Locations

US (2)