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.
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
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
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
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
Time frame: 18 months
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.
Time frame: 18 months
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