Register a trial

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

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 endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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

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
Recruitment postcode(s) [4] 0 0
4032 - Chermside
Recruitment postcode(s) [5] 0 0
5042 - Bedford Park
Recruitment postcode(s) [6] 0 0
7250 - Launceston
Recruitment postcode(s) [7] 0 0
3065 - Fitzroy
Recruitment postcode(s) [8] 0 0
3220 - Geelong
Recruitment postcode(s) [9] 0 0
3081 - Heidelberg Heights
Recruitment postcode(s) [10] 0 0
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
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
Arizona
Country [3] 0 0
United States of America
State/province [3] 0 0
Arkansas
Country [4] 0 0
United States of America
State/province [4] 0 0
California
Country [5] 0 0
United States of America
State/province [5] 0 0
Colorado
Country [6] 0 0
United States of America
State/province [6] 0 0
Connecticut
Country [7] 0 0
United States of America
State/province [7] 0 0
Delaware
Country [8] 0 0
United States of America
State/province [8] 0 0
District of Columbia
Country [9] 0 0
United States of America
State/province [9] 0 0
Florida
Country [10] 0 0
United States of America
State/province [10] 0 0
Georgia
Country [11] 0 0
United States of America
State/province [11] 0 0
Hawaii
Country [12] 0 0
United States of America
State/province [12] 0 0
Illinois
Country [13] 0 0
United States of America
State/province [13] 0 0
Indiana
Country [14] 0 0
United States of America
State/province [14] 0 0
Iowa
Country [15] 0 0
United States of America
State/province [15] 0 0
Kansas
Country [16] 0 0
United States of America
State/province [16] 0 0
Kentucky
Country [17] 0 0
United States of America
State/province [17] 0 0
Louisiana
Country [18] 0 0
United States of America
State/province [18] 0 0
Maine
Country [19] 0 0
United States of America
State/province [19] 0 0
Maryland
Country [20] 0 0
United States of America
State/province [20] 0 0
Massachusetts
Country [21] 0 0
United States of America
State/province [21] 0 0
Michigan
Country [22] 0 0
United States of America
State/province [22] 0 0
Minnesota
Country [23] 0 0
United States of America
State/province [23] 0 0
Mississippi
Country [24] 0 0
United States of America
State/province [24] 0 0
Missouri
Country [25] 0 0
United States of America
State/province [25] 0 0
Nebraska
Country [26] 0 0
United States of America
State/province [26] 0 0
Nevada
Country [27] 0 0
United States of America
State/province [27] 0 0
New Jersey
Country [28] 0 0
United States of America
State/province [28] 0 0
New Mexico
Country [29] 0 0
United States of America
State/province [29] 0 0
New York
Country [30] 0 0
United States of America
State/province [30] 0 0
North Carolina
Country [31] 0 0
United States of America
State/province [31] 0 0
North Dakota
Country [32] 0 0
United States of America
State/province [32] 0 0
Ohio
Country [33] 0 0
United States of America
State/province [33] 0 0
Oklahoma
Country [34] 0 0
United States of America
State/province [34] 0 0
Oregon
Country [35] 0 0
United States of America
State/province [35] 0 0
Pennsylvania
Country [36] 0 0
United States of America
State/province [36] 0 0
South Carolina
Country [37] 0 0
United States of America
State/province [37] 0 0
South Dakota
Country [38] 0 0
United States of America
State/province [38] 0 0
Tennessee
Country [39] 0 0
United States of America
State/province [39] 0 0
Texas
Country [40] 0 0
United States of America
State/province [40] 0 0
Utah
Country [41] 0 0
United States of America
State/province [41] 0 0
Virginia
Country [42] 0 0
United States of America
State/province [42] 0 0
Washington
Country [43] 0 0
United States of America
State/province [43] 0 0
West Virginia
Country [44] 0 0
Canada
State/province [44] 0 0
Alberta
Country [45] 0 0
Canada
State/province [45] 0 0
British Columbia
Country [46] 0 0
Canada
State/province [46] 0 0
Ontario
Country [47] 0 0
Canada
State/province [47] 0 0
Quebec
Country [48] 0 0
Canada
State/province [48] 0 0
Québec
Country [49] 0 0
India
State/province [49] 0 0
Andhra Pradesh
Country [50] 0 0
India
State/province [50] 0 0
Delhi
Country [51] 0 0
India
State/province [51] 0 0
Karnataka
Country [52] 0 0
India
State/province [52] 0 0
Kerala
Country [53] 0 0
India
State/province [53] 0 0
Maharashtra
Country [54] 0 0
India
State/province [54] 0 0
Tamil Nadu
Country [55] 0 0
Netherlands
State/province [55] 0 0
Almelo
Country [56] 0 0
Netherlands
State/province [56] 0 0
Amersfoort
Country [57] 0 0
Netherlands
State/province [57] 0 0
Blaricum
Country [58] 0 0
Netherlands
State/province [58] 0 0
Capelle aan den Ijssel
Country [59] 0 0
Netherlands
State/province [59] 0 0
Den Haag
Country [60] 0 0
Netherlands
State/province [60] 0 0
Den Helder
Country [61] 0 0
Netherlands
State/province [61] 0 0
Deventer
Country [62] 0 0
Netherlands
State/province [62] 0 0
Ede
Country [63] 0 0
Netherlands
State/province [63] 0 0
Eindhoven
Country [64] 0 0
Netherlands
State/province [64] 0 0
Enschede
Country [65] 0 0
Netherlands
State/province [65] 0 0
Goes
Country [66] 0 0
Netherlands
State/province [66] 0 0
Gorinchem
Country [67] 0 0
Netherlands
State/province [67] 0 0
Gouda
Country [68] 0 0
Netherlands
State/province [68] 0 0
Groningen
Country [69] 0 0
Netherlands
State/province [69] 0 0
Haarlem
Country [70] 0 0
Netherlands
State/province [70] 0 0
Harderwijk
Country [71] 0 0
Netherlands
State/province [71] 0 0
Heerenveen
Country [72] 0 0
Netherlands
State/province [72] 0 0
Heerlen
Country [73] 0 0
Netherlands
State/province [73] 0 0
Hoofddorp
Country [74] 0 0
Netherlands
State/province [74] 0 0
Leeuwarden
Country [75] 0 0
Netherlands
State/province [75] 0 0
Leiderdorp
Country [76] 0 0
Netherlands
State/province [76] 0 0
Nijmegen
Country [77] 0 0
Netherlands
State/province [77] 0 0
Roosendaal
Country [78] 0 0
Netherlands
State/province [78] 0 0
Rotterdam
Country [79] 0 0
Netherlands
State/province [79] 0 0
s'Hertogenbosch
Country [80] 0 0
Netherlands
State/province [80] 0 0
Schiedam
Country [81] 0 0
Netherlands
State/province [81] 0 0
Sneek
Country [82] 0 0
Netherlands
State/province [82] 0 0
Tilburg
Country [83] 0 0
Netherlands
State/province [83] 0 0
Uden
Country [84] 0 0
Netherlands
State/province [84] 0 0
Veldhoven
Country [85] 0 0
Netherlands
State/province [85] 0 0
Zoetermeer
Country [86] 0 0
Netherlands
State/province [86] 0 0
Zutphen
Country [87] 0 0
New Zealand
State/province [87] 0 0
Auckland
Country [88] 0 0
New Zealand
State/province [88] 0 0
Christchurch
Country [89] 0 0
New Zealand
State/province [89] 0 0
Dunedin
Country [90] 0 0
New Zealand
State/province [90] 0 0
Hamilton
Country [91] 0 0
New Zealand
State/province [91] 0 0
Hastings
Country [92] 0 0
New Zealand
State/province [92] 0 0
Nelson
Country [93] 0 0
New Zealand
State/province [93] 0 0
New Plymouth
Country [94] 0 0
New Zealand
State/province [94] 0 0
Takapuna Auckland
Country [95] 0 0
New Zealand
State/province [95] 0 0
Tauranga
Country [96] 0 0
New Zealand
State/province [96] 0 0
Whangarei
Country [97] 0 0
Poland
State/province [97] 0 0
Bialystok
Country [98] 0 0
Poland
State/province [98] 0 0
Katowice
Country [99] 0 0
Poland
State/province [99] 0 0
Kraków
Country [100] 0 0
Poland
State/province [100] 0 0
Mikolów
Country [101] 0 0
Poland
State/province [101] 0 0
Skierniewice
Country [102] 0 0
Poland
State/province [102] 0 0
Tarnów
Country [103] 0 0
Poland
State/province [103] 0 0
Warszawa
Country [104] 0 0
Poland
State/province [104] 0 0
Warszawska
Country [105] 0 0
Poland
State/province [105] 0 0
Wroclaw
Country [106] 0 0
Poland
State/province [106] 0 0
Zgierz
Country [107] 0 0
Romania
State/province [107] 0 0
Arges
Country [108] 0 0
Romania
State/province [108] 0 0
Braila
Country [109] 0 0
Romania
State/province [109] 0 0
Bucharest
Country [110] 0 0
Romania
State/province [110] 0 0
Bucuresti
Country [111] 0 0
Romania
State/province [111] 0 0
Cluj-Napoca
Country [112] 0 0
Romania
State/province [112] 0 0
Constanta
Country [113] 0 0
Romania
State/province [113] 0 0
Craiova, Dolj
Country [114] 0 0
Romania
State/province [114] 0 0
Iasi
Country [115] 0 0
Romania
State/province [115] 0 0
Maramures
Country [116] 0 0
Romania
State/province [116] 0 0
Mures
Country [117] 0 0
Romania
State/province [117] 0 0
Sibiu
Country [118] 0 0
Romania
State/province [118] 0 0
Timisoara
Country [119] 0 0
Romania
State/province [119] 0 0
Târgu Mures
Country [120] 0 0
Russian Federation
State/province [120] 0 0
Arkhangelsk
Country [121] 0 0
Russian Federation
State/province [121] 0 0
Ekaterinburg
Country [122] 0 0
Russian Federation
State/province [122] 0 0
Kazan
Country [123] 0 0
Russian Federation
State/province [123] 0 0
Kemerovo
Country [124] 0 0
Russian Federation
State/province [124] 0 0
Kirovsk, Leningradskaya Region
Country [125] 0 0
Russian Federation
State/province [125] 0 0
Krasnodar
Country [126] 0 0
Russian Federation
State/province [126] 0 0
Moscow
Country [127] 0 0
Russian Federation
State/province [127] 0 0
Nizhny Novgorod
Country [128] 0 0
Russian Federation
State/province [128] 0 0
Novosibirsk
Country [129] 0 0
Russian Federation
State/province [129] 0 0
Petrozavodsk
Country [130] 0 0
Russian Federation
State/province [130] 0 0
Saint-Petersburg
Country [131] 0 0
Russian Federation
State/province [131] 0 0
Saratov
Country [132] 0 0
Russian Federation
State/province [132] 0 0
Sestroretsk, Saint-Petersburg
Country [133] 0 0
Russian Federation
State/province [133] 0 0
Tomsk
Country [134] 0 0
Russian Federation
State/province [134] 0 0
Volgograd
Country [135] 0 0
Russian Federation
State/province [135] 0 0
Voronezh
Country [136] 0 0
Russian Federation
State/province [136] 0 0
Yaroslavl
Country [137] 0 0
South Africa
State/province [137] 0 0
Freestate
Country [138] 0 0
South Africa
State/province [138] 0 0
Gauteng
Country [139] 0 0
South Africa
State/province [139] 0 0
KwaZulu-Natal
Country [140] 0 0
South Africa
State/province [140] 0 0
Western Cape
Country [141] 0 0
Ukraine
State/province [141] 0 0
Volyn Region
Country [142] 0 0
Ukraine
State/province [142] 0 0
Cherkasy
Country [143] 0 0
Ukraine
State/province [143] 0 0
Chernivtsi
Country [144] 0 0
Ukraine
State/province [144] 0 0
Dnipropetrovsk
Country [145] 0 0
Ukraine
State/province [145] 0 0
Donetsk
Country [146] 0 0
Ukraine
State/province [146] 0 0
Ivano-Frankivsk
Country [147] 0 0
Ukraine
State/province [147] 0 0
Kharkiv
Country [148] 0 0
Ukraine
State/province [148] 0 0
Kyiv
Country [149] 0 0
Ukraine
State/province [149] 0 0
Luhansk
Country [150] 0 0
Ukraine
State/province [150] 0 0
Lutsk
Country [151] 0 0
Ukraine
State/province [151] 0 0
Lviv
Country [152] 0 0
Ukraine
State/province [152] 0 0
Odesa
Country [153] 0 0
Ukraine
State/province [153] 0 0
Poltava
Country [154] 0 0
Ukraine
State/province [154] 0 0
Ternopil
Country [155] 0 0
Ukraine
State/province [155] 0 0
Uzhgorod
Country [156] 0 0
Ukraine
State/province [156] 0 0
Vinnytsya
Country [157] 0 0
Ukraine
State/province [157] 0 0
Zaporizhzhia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Amarin Pharma Inc.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?




Results publications and other study-related documents

TypeCitations or Other Details
Journal Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson ... [More Details]
Journal Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson ... [More Details]
Journal Bhatt DL, Miller M, Brinton EA, Jacobson TA, Steg ... [More Details]
Journal Olshansky B, Bhatt DL, Miller M, Steg PG, Brinton ... [More Details]
Journal Peterson BE, Bhatt DL, Steg PG, Miller M, Brinton ... [More Details]
Journal Bhatt DL, Steg PG, Miller M, Brinton EA, Jacobson ... [More Details]
Journal Gaba P, Bhatt DL, Giugliano RP, Steg PG, Miller M,... [More Details]
Journal Majithia A, Bhatt DL, Friedman AN, Miller M, Steg ... [More Details]
Journal Verma S, Bhatt DL, Steg PG, Miller M, Brinton EA, ... [More Details]
Journal Singh N, Bhatt DL, Miller M, Steg PG, Brinton EA, ... [More Details]


Results are available at https://clinicaltrials.gov/study/NCT01492361