A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Hypertriglyceridemia
Intervention: AMR101; Placebo; Statin therapy
Intervention description: Parallel Assignment; Parallel Assignment; Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)
Intervention MeSH terms: Eicosapentaenoic acid ethyl ester
Phase: Phase 3
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Enrollment: 8179.0
Sex: All
Minimum age: 45 Years
Healthy volunteers: No
Keywords: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Heart Diseases; Acute Coronary Syndrome; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Angina Pectoris; Chest Pain; Anticholesteremic Agents; Hypolipidemic Agents; Lipid Regulating Agents; Hypertriglyceridemia; Omega-3 Fatty Acids; Statin; Triglycerides; EPA; Docosahexaenoic Acid; Fish; Fatty acids; Fibrates; Niacin; Lipids; Lipoprotein; Atorvastatin; Lovaza; Simvastatin; Lovastatin; Pravastatin; Fluvastatin; Rosuvastatin; Trilipix; Vytorin; Simcor; Ezetimibe; Zetia; Ethyl-EPA; Ethyl Icosapentate; Crestor; Zocor; Lipitor; LDL; HDL; Cholesterol; Dyslipidemia; AMR101; Cardiovascular Disease, Unspecified; VASCEPA; Icosapent Ethyl

Summary:

      AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic
      acid (EPA) developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in
      statin-treated patients with hypertriglyceridemia. The purpose of this study was to evaluate
      whether this drug, combined with a statin therapy, will be superior to the statin therapy
      alone, when used as a prevention in reducing long-term cardiovascular events in high-risk
      patients with mixed dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Men and non-pregnant or sterile women ages 45 and older

          -  Hypertriglyceridemia

          -  On statin therapy for at least four weeks

          -  Either having established cardiovascular disease or at high risk for cardiovascular
             disease

        Exclusion Criteria:

          -  Severe heart failure

          -  Any life-threatening disease other than cardiovascular disease

          -  Active severe liver disease

          -  Hemoglobin A1c >10.0%

          -  Poorly controlled hypertension

          -  Planned coronary intervention (such as stent placement or heart bypass) or any
             non-cardiac major surgical procedure

          -  Known familial lipoprotein lipase deficiency (Fredrickson Type I), apolipoprotein C-II
             deficiency, or familial dysbetalipoproteinemia (Fredrickson Type III)

          -  Known hypersensitivity to the study product, fish and/or shellfish, or placebo

          -  History of acute or chronic pancreatitis

          -  Patients are excluded if using the following medications:

               -  PCSK9 inhibitors

               -  niacin >200 mg/day or fibrates;

               -  any omega-3 fatty acid medications ;

               -  dietary supplements containing omega-3 fatty acids (e.g., flaxseed oil, fish oil,
                  krill oil, or algal oil);

               -  bile acid sequestrants