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Completed

NCT Number: NCT01492361

A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin

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.

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Key information

Conditions

Cardiovascular Diseases Acute Coronary Syndrome Angina Pectoris Arterial Occlusive Diseases Arteriosclerosis Chest Pain Coronary Artery Disease Coronary Disease Dyslipidemias Heart Diseases Hyperlipidemias Hypertriglyceridemia Lipid Metabolism Disorders Metabolic Diseases Myocardial Ischemia Neurologic Manifestations Nutritional and Metabolic Diseases Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Vascular Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Amarin Investigational Site, Camperdown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AMR101

Drug

Parallel Assignment

Other names: VASCEPA® (icosapent ethyl)

Placebo

Drug

Parallel Assignment

Other names: matching placebo

Statin therapy

Drug

Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)

Primary outcomes

  1. 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.

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

Secondary outcomes

  1. Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

  2. Composite of CV Death or Nonfatal MI (Including Silent MI).

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

  3. Fatal or Nonfatal MI (Including Silent MI).

    Time frame: Total follow-up time of up to approximately 6 years.

    Number of patients with a first occurrence of fatal or nonfatal MI (including silent MI) during the follow-up period.

  4. Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

  5. CV Death.

    Time frame: Total follow-up time of up to approximately 6 years.

    Number of patients with an occurrence of CV death during the follow-up period.

  6. Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

  7. Fatal or Nonfatal Stroke.

    Time frame: Total follow-up time of up to approximately 6 years.

    Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.

  8. Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.

    Time frame: Total follow-up time of up to approximately 6 years.

    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.

  9. Total Mortality.

    Time frame: Total follow-up time of up to approximately 6 years.

    Number of patients with an occurrence of death from any cause during the follow-up period.

Sponsors and collaborators

Lead sponsor

Amarin Pharma Inc.

Industry

Registry information

Official study title

Evaluation of the Effect of AMR101 on Cardiovascular Health and Mortality in Hypertriglyceridemic Patients With Cardiovascular Disease or at High Risk for Cardiovascular Disease: REDUCE-IT (Reduction of Cardiovascular Events With EPA - Intervention Trial)

Acronym: REDUCE-IT

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Dec 15, 2011
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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