Effect of Vascepa on Improving Coronary Atherosclerosis in People With High Triglycerides Taking Statin Therapy
Condition: Hypertriglyceridemia
MeSH terms: Atherosclerosis; Coronary Artery Disease; Myocardial Ischemia; Hypertriglyceridemia
Intervention: Vascepa; placebo
Intervention description: Vascepa is a an Eicosapentaenoic acid (EPA), an omega-3 polyunsaturated fatty acid.; placebo
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 80.0
Sex: All
Minimum age: 30 Years
Maximum age: 85 Years
Healthy volunteers: No

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.
    

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