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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01492361
Recruitment Status : Completed
First Posted : December 15, 2011
Results First Posted : April 14, 2022
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Drug: AMR101 Drug: Placebo Drug: Statin therapy Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official 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)
Actual Study Start Date : November 2011
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: AMR101
AMR101 (icosapent ethyl) + statin therapy, daily
 Drug: AMR101
Parallel Assignment
Other Name: VASCEPA® (icosapent ethyl)

Drug: Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and ≤100 mg/dL)
Placebo Comparator: Placebo
Placebo + statin therapy, daily
 Drug: Placebo
Parallel Assignment
Other Name: matching placebo

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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492361


Locations
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Sponsors and Collaborators
Amarin Pharma Inc.
Investigators
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Principal Investigator: Deepak L. Bhatt, MD, MPH Brigham and Women's Hospital, 75 Francis Street, Boston
  Study Documents (Full-Text)

Documents provided by Amarin Pharma Inc.:
Study Protocol and Statistical Analysis Plan  [PDF] July 8, 2016

More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Amarin Pharma Inc.
ClinicalTrials.gov Identifier: NCT01492361    
Other Study ID Numbers: AMR-01-01-0019
First Posted: December 15, 2011    Key Record Dates
Results First Posted: April 14, 2022
Last Update Posted: April 14, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Amarin Pharma Inc.:
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
Additional relevant MeSH terms:
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Cardiovascular Diseases
Hypertriglyceridemia
Hyperlipidemias
Dyslipidemias
Lipid Metabolism Disorders
 Metabolic Diseases
Eicosapentaenoic acid ethyl ester
Platelet Aggregation Inhibitors
Lipid Regulating Agents