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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
8,179
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)
Composite of CV Death, Nonfatal MI (Including Silent MI), Nonfatal Stroke, Coronary Revascularization, or Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
The primary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, or unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
The key secondary outcome measure was the number of patients with a first occurrence of any component of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Composite of CV Death or Nonfatal MI (Including Silent MI).
Number of patients with a first occurrence of any component of the composite of CV death or nonfatal MI (including silent MI) during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Fatal or Nonfatal MI (Including Silent MI).
Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
Number of patients with a first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications during the follow-up period.
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Amarin Investigational Site
Birmingham, Alabama, United States
Amarin Investigational Site
Birmingham, Alabama, United States
Amarin Investigational Site
Huntsville, Alabama, United States
Amarin Investigational Site
Mobile, Alabama, United States
Amarin Investigational Site
Muscle Shoals, Alabama, United States
Amarin Investigational Site
Mesa, Arizona, United States
Amarin Investigational Site
Phoenix, Arizona, United States
Amarin Investigational Site
Tucson, Arizona, United States
Amarin Investigational Site
Little Rock, Arkansas, United States
Amarin Investigational Site
Beverly Hills, California, United States
...and 400 more locations
Time frame: Total follow-up time of up to approximately 6 years.
CV Death.
Number of patients with an occurrence of CV death during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
Number of patients with a first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Fatal or Nonfatal Stroke.
Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Number of patients with a first occurrence of any component of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.
Total Mortality.
Number of patients with an occurrence of death from any cause during the follow-up period.
Time frame: Total follow-up time of up to approximately 6 years.