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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01492361




Registration number
NCT01492361
Ethics application status
Date submitted
13/12/2011
Date registered
15/12/2011
Date last updated
14/04/2022

Titles & IDs
Public title
A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
Scientific 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)
Secondary ID [1] 0 0
AMR-01-01-0019
Universal Trial Number (UTN)
Trial acronym
REDUCE-IT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cardiovascular Diseases 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - AMR101
Treatment: Drugs - Placebo
Treatment: Drugs - Statin therapy

Experimental: AMR101 - AMR101 (icosapent ethyl) + statin therapy, daily

Placebo comparator: Placebo - Placebo + statin therapy, daily


Treatment: Drugs: AMR101
Parallel Assignment

Treatment: Drugs: Placebo
Parallel Assignment

Treatment: Drugs: Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and =100 mg/dL)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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.
Timepoint [1] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [1] 0 0
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Timepoint [1] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [2] 0 0
Composite of CV Death or Nonfatal MI (Including Silent MI).
Timepoint [2] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [3] 0 0
Fatal or Nonfatal MI (Including Silent MI).
Timepoint [3] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [4] 0 0
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
Timepoint [4] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [5] 0 0
CV Death.
Timepoint [5] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [6] 0 0
Unstable Angina Determined to be Caused by Myocardial Ischemia by Invasive / Non-invasive Testing and Requiring Emergent Hospitalization.
Timepoint [6] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [7] 0 0
Fatal or Nonfatal Stroke.
Timepoint [7] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [8] 0 0
Total Mortality, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Timepoint [8] 0 0
Total follow-up time of up to approximately 6 years.
Secondary outcome [9] 0 0
Total Mortality.
Timepoint [9] 0 0
Total follow-up time of up to approximately 6 years.

Eligibility
Key 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
Minimum age
45 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/11/2011
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2018
Sample size
Target
Accrual to date
Final
8179
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
Amarin Investigational Site - Camperdown
Recruitment hospital [2] 0 0
Amarin Investigational Site - Lismore
Recruitment hospital [3] 0 0
Amarin Investigational Site - Brisbane
Recruitment hospital [4] 0 0
Amarin Investigational Site - Chermside
Recruitment hospital [5] 0 0
Amarin Investigational Site - Bedford Park
Recruitment hospital [6] 0 0
Amarin Investigational Site - Launceston
Recruitment hospital [7] 0 0
Amarin Investigational Site - Fitzroy
Recruitment hospital [8] 0 0
Amarin Investigational Site - Geelong
Recruitment hospital [9] 0 0
Amarin Investigational Site - Heidelberg Heights
Recruitment hospital [10] 0 0
Amarin Investigational Site - Melbourne
Recruitment hospital [11] 0 0
Amarin Investigational Site - Fremantle
Recruitment hospital [12] 0 0
Amarin Investigational Site - Joondalup
Recruitment hospital [13] 0 0
Amarin Investigational Site - Murdoch
Recruitment hospital [14] 0 0
Amarin Investigational Site - Nedlands
Recruitment hospital [15] 0 0
Amarin Investigational Site - Perth
Recruitment postcode(s) [1] 0 0
2015 - Camperdown
Recruitment postcode(s) [2] 0 0
2480 - Lismore
Recruitment postcode(s) [3] 0 0
4064 - Brisbane
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4032 - Chermside
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5042 - Bedford Park
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7250 - Launceston
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3065 - Fitzroy
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3220 - Geelong
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3081 - Heidelberg Heights
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3004 - Melbourne
Recruitment postcode(s) [11] 0 0
6160 - Fremantle
Recruitment postcode(s) [12] 0 0
6027 - Joondalup
Recruitment postcode(s) [13] 0 0
6150 - Murdoch
Recruitment postcode(s) [14] 0 0
6009 - Nedlands
Recruitment postcode(s) [15] 0 0
6000 - Perth
Recruitment outside Australia
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amarin Pharma Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT01492361
Trial related presentations / publications
Bhatt DL, Steg PG, Brinton EA, Jacobson TA, Miller M, Tardif JC, Ketchum SB, Doyle RT Jr, Murphy SA, Soni PN, Braeckman RA, Juliano RA, Ballantyne CM; REDUCE-IT Investigators. Rationale and design of REDUCE-IT: Reduction of Cardiovascular Events with Icosapent Ethyl-Intervention Trial. Clin Cardiol. 2017 Mar;40(3):138-148. doi: 10.1002/clc.22692. Epub 2017 Mar 15.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Cardiovascular Risk Reduction with Icosapent Ethyl for Hypertriglyceridemia. N Engl J Med. 2019 Jan 3;380(1):11-22. doi: 10.1056/NEJMoa1812792. Epub 2018 Nov 10.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Effects of Icosapent Ethyl on Total Ischemic Events: From REDUCE-IT. J Am Coll Cardiol. 2019 Jun 11;73(22):2791-2802. doi: 10.1016/j.jacc.2019.02.032. Epub 2019 Mar 18.
Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg PG, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Olshansky B, Chung MK, Gibson CM, Giugliano RP, Budoff MJ, Ballantyne CM; REDUCE-IT Investigators. REDUCE-IT USA: Results From the 3146 Patients Randomized in the United States. Circulation. 2020 Feb 4;141(5):367-375. doi: 10.1161/CIRCULATIONAHA.119.044440. Epub 2019 Nov 11.
Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Granowitz C, Tardif JC, Mehta C, Mukherjee R, Ballantyne CM, Chung MK; REDUCE-IT Investigators. REDUCE-IT INTERIM: accumulation of data across prespecified interim analyses to final results. Eur Heart J Cardiovasc Pharmacother. 2021 May 23;7(3):e61-e63. doi: 10.1093/ehjcvp/pvaa118. No abstract available.
Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Reduction in Revascularization With Icosapent Ethyl: Insights From REDUCE-IT Revascularization Analyses. Circulation. 2021 Jan 5;143(1):33-44. doi: 10.1161/CIRCULATIONAHA.120.050276. Epub 2020 Nov 5.
Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Gregson J, Pocock SJ, Ballantyne CM; REDUCE-IT Investigators. Reduction in First and Total Ischemic Events With Icosapent Ethyl Across Baseline Triglyceride Tertiles. J Am Coll Cardiol. 2019 Aug 27;74(8):1159-1161. doi: 10.1016/j.jacc.2019.06.043. No abstract available.
Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Ballantyne CM, Pinto DS, Budoff MJ, Gibson CM. Comparative Reductions in Investigator-Reported and Adjudicated Ischemic Events in REDUCE-IT. J Am Coll Cardiol. 2021 Oct 12;78(15):1525-1537. doi: 10.1016/j.jacc.2021.08.009.
Majithia A, Bhatt DL, Friedman AN, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Budoff M, Preston Mason R, Tardif JC, Boden WE, Ballantyne CM. Benefits of Icosapent Ethyl Across the Range of Kidney Function in Patients With Established Cardiovascular Disease or Diabetes: REDUCE-IT RENAL. Circulation. 2021 Nov 30;144(22):1750-1759. doi: 10.1161/CIRCULATIONAHA.121.055560. Epub 2021 Oct 28.
Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Dhingra NK, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Mason RP, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Icosapent Ethyl Reduces Ischemic Events in Patients With a History of Previous Coronary Artery Bypass Grafting: REDUCE-IT CABG. Circulation. 2021 Dec 7;144(23):1845-1855. doi: 10.1161/CIRCULATIONAHA.121.056290. Epub 2021 Oct 28.
Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Jiao L, Tardif JC, Mason RP, Ballantyne CM; REDUCE-IT Investigators. Consistency of Benefit of Icosapent Ethyl by Background Statin Type in REDUCE-IT. J Am Coll Cardiol. 2022 Jan 18;79(2):220-222. doi: 10.1016/j.jacc.2021.11.005. No abstract available.
Ridker PM, Rifai N, MacFadyen J, Glynn RJ, Jiao L, Steg PG, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Mason RP, Bhatt DL. Effects of Randomized Treatment With Icosapent Ethyl and a Mineral Oil Comparator on Interleukin-1beta, Interleukin-6, C-Reactive Protein, Oxidized Low-Density Lipoprotein Cholesterol, Homocysteine, Lipoprotein(a), and Lipoprotein-Associated Phospholipase A2: A REDUCE-IT Biomarker Substudy. Circulation. 2022 Aug 2;146(5):372-379. doi: 10.1161/CIRCULATIONAHA.122.059410. Epub 2022 Jun 28.
Gaba P, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Tardif JC, Giugliano RP, Martens FMAC, Gibson CM, Ballantyne CM; REDUCE-IT Investigators. Prevention of Cardiovascular Events and Mortality With Icosapent Ethyl in Patients With Prior Myocardial Infarction. J Am Coll Cardiol. 2022 May 3;79(17):1660-1671. doi: 10.1016/j.jacc.2022.02.035.
Selvaraj S, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Juliano RA, Jiao L, Tardif JC, Ballantyne CM; REDUCE-IT Investigators. Impact of Icosapent Ethyl on Cardiovascular Risk Reduction in Patients With Heart Failure in REDUCE-IT. J Am Heart Assoc. 2022 Apr 5;11(7):e024999. doi: 10.1161/JAHA.121.024999. Epub 2022 Apr 4.
Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Juliano RA, Jiao L, Doyle RT Jr, Granowitz C, Gibson CM, Pinto D, Giugliano RP, Budoff MJ, Tardif JC, Verma S, Ballantyne CM; REDUCE-IT Investigators. Treatment With Icosapent Ethyl to Reduce Ischemic Events in Patients With Prior Percutaneous Coronary Intervention: Insights From REDUCE-IT PCI. J Am Heart Assoc. 2022 Mar 15;11(6):e022937. doi: 10.1161/JAHA.121.022937. Epub 2022 Mar 9.
Public notes

Contacts
Principal investigator
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Deepak L. Bhatt, MD, MPH
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Brigham and Women's Hospital, 75 Francis Street, Boston
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Fax 0 0
Email 0 0
Contact person for public queries
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Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT01492361