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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. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event. (REDUCE-IT)

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ClinicalTrials.gov Identifier: NCT01492361
Recruitment Status : Completed
First Posted : December 15, 2011
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
Amarin Pharma Inc.

Tracking Information
First Submitted Date  ICMJE December 13, 2011
First Posted Date  ICMJE December 15, 2011
Last Update Posted Date October 16, 2018
Actual Study Start Date  ICMJE November 2011
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
Composite of CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, and unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization. [ Time Frame: 4-6 years ]
Time from randomization to the first occurrence of any component of the composite of the following clinical events: CV death, nonfatal MI (including silent MI), nonfatal stroke, coronary revascularization, and unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization.
Original Primary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
Incidence of cardiovascular events, such as coronary revascularization. [ Time Frame: 4-6 years ]
Change History Complete list of historical versions of study NCT01492361 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 12, 2018)
  • Composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke. [ Time Frame: 4-6 years ]
    Key secondary outcome measure is the time from randomization to the first occurrence of the composite of CV death, nonfatal MI (including silent MI), or nonfatal stroke.
  • Composite of CV death or nonfatal MI (including silent MI). [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of the composite of CV death or nonfatal MI (including silent MI).
  • Fatal or nonfatal MI (including silent MI). [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of fatal or nonfatal MI (including silent MI).
  • Non-elective coronary revascularization represented as the composite of emergent or urgent classifications. [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of non-elective coronary revascularization represented as the composite of emergent or urgent classifications.
  • CV death. [ Time Frame: 4-6 years ]
    Time from randomization to the occurrence of CV death.
  • Unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization. [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of unstable angina determined to be caused by myocardial ischemia by invasive / non-invasive testing and requiring emergent hospitalization.
  • Fatal or nonfatal stroke. [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of fatal or nonfatal stroke.
  • Total mortality, nonfatal MI (including silent MI), or nonfatal stroke. [ Time Frame: 4-6 years ]
    Time from randomization to the first occurrence of the composite of total mortality, nonfatal MI (including silent MI), or nonfatal stroke.
  • Total mortality. [ Time Frame: 4-6 years. ]
    Time from randomization to the occurrence of death from any cause.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 13, 2011)
Incidence of additional cardiovascular events, lipid and lipoprotein levels, subgroup analyses such as: diabetics, etc. [ Time Frame: 4-6 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High Risk Patients With Hypertriglyceridemia and on Statin. The Primary Objective is to Evaluate the Effect of 4 g/Day AMR101 for Preventing the Occurrence of a First Major Cardiovascular Event.
Official Title  ICMJE 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)
Brief Summary AMR101 (icosapent ethyl [ethyl-EPA]) is a highly purified ethyl ester of eicosapentaenoic acid (EPA) being developed by Amarin Pharma Inc. for the treatment of cardiovascular disease in statin-treated patients with hypertriglyceridemia. The purpose of this study is 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE Cardiovascular Diseases
Intervention  ICMJE
  • Drug: AMR101
    Parallel Assignment
    Other Name: VASCEPA® (icosapent ethyl)
  • Drug: Placebo
    Parallel Assignment
Study Arms  ICMJE
  • Experimental: AMR101
    Intervention: Drug: AMR101
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 12, 2018)
8179
Original Estimated Enrollment  ICMJE
 (submitted: December 13, 2011)
8000
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   India,   Netherlands,   New Zealand,   Poland,   Romania,   Russian Federation,   South Africa,   Ukraine,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492361
Other Study ID Numbers  ICMJE AMR-01-01-0019
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Amarin Pharma Inc.
Study Sponsor  ICMJE Amarin Pharma Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Deepak L. Bhatt, MD, MPH Brigham and Women's Hospital, 75 Francis Street, Boston
PRS Account Amarin Pharma Inc.
Verification Date October 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP