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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)

Primary Purpose

Cardiovascular Diseases

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

AMR101

Placebo

Statin therapy

About this trial

This is an interventional prevention trial for Cardiovascular Diseases focused on measuring 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

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

AMR101

Placebo

Arm Description

AMR101 (icosapent ethyl) + statin therapy, daily

Placebo + statin therapy, daily

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

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.

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.

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.

CV Death.

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

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.

Fatal or Nonfatal Stroke.

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

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.

Total Mortality.

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

Full Information

NCT ID

NCT01492361

First Posted

December 13, 2011

Last Updated

March 21, 2022

Sponsor

Amarin Pharma Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01492361

Brief Title

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

Acronym

REDUCE-IT

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)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2022

Overall Recruitment Status

Completed

Study Start Date

November 2011 (Actual)

Primary Completion Date

May 2018 (Actual)

Study Completion Date

May 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Amarin Pharma Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Cardiovascular Diseases

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

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

8179 (Actual)

8. Arms, Groups, and Interventions

Arm Title

AMR101

Arm Type

Experimental

Arm Description

AMR101 (icosapent ethyl) + statin therapy, daily

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo + statin therapy, daily

Intervention Type

Drug

Intervention Name(s)

AMR101

Other Intervention Name(s)

VASCEPA® (icosapent ethyl)

Intervention Description

Parallel Assignment

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

matching placebo

Intervention Description

Parallel Assignment

Intervention Type

Drug

Intervention Name(s)

Statin therapy

Intervention Description

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

Primary Outcome Measure Information:

Title

Description

Time Frame