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

Cardiovascular Diseases Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01492361
• Other study ID #: AMR-01-01-0019
• Status: Completed
• Phase: Phase 3
• Start date: November 2011
• Est. completion date: May 2018

Study information

• Verified date: March 2022
• Source: Amarin Pharma Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8179
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertriglyceridemia

Intervention

Drug:
• AMR101
Parallel Assignment
• Placebo
Parallel Assignment
• Statin therapy
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C >40 mg/dL and =100 mg/dL)

Locations

Country	Name	City	State
Australia	Amarin Investigational Site	Bedford Park	South Australia
Australia	Amarin Investigational Site	Brisbane	Queensland
Australia	Amarin Investigational Site	Camperdown	New South Wales
Australia	Amarin Investigational Site	Chermside	Queensland
Australia	Amarin Investigational Site	Fitzroy	Victoria
Australia	Amarin Investigational Site	Fremantle	Western Australia
Australia	Amarin Investigational Site	Geelong	Victoria
Australia	Amarin Investigational Site	Heidelberg Heights	Victoria
Australia	Amarin Investigational Site	Joondalup	Western Australia
Australia	Amarin Investigational Site	Launceston	Tasmania
Australia	Amarin Investigational Site	Lismore	New South Wales
Australia	Amarin Investigational Site	Melbourne	Victoria
Australia	Amarin Investigational Site	Murdoch	Western Australia
Australia	Amarin Investigational Site	Nedlands	Western Australia
Australia	Amarin Investigational Site	Perth	Western Australia
Canada	Amarin Investigational Site	Brampton	Ontario
Canada	Amarin Investigational Site	Collingwood	Ontario
Canada	Amarin Investigational Site	Coquitlam	British Columbia
Canada	Amarin Investigational Site	Corunna	Ontario
Canada	Amarin Investigational Site	Edmonton	Alberta
Canada	Amarin Investigational Site	Laval	Quebec
Canada	Amarin Investigational Site	Montreal	Quebec
Canada	Amarin Investigational Site	Montreal	Quebec
Canada	Amarin Investigational Site	Newmarket	Ontario
Canada	Amarin Investigational Site	Québec
Canada	Amarin Investigational Site	Québec
Canada	Amarin Investigational Site	Sarnia	Ontario
Canada	Amarin Investigational Site	Sherbrooke	Quebec
Canada	Amarin Investigational Site	St. Charles-Borromée	Quebec
Canada	Amarin Investigational Site	Strathroy	Ontario
Canada	Amarin Investigational Site	Vancouver	British Columbia
Canada	Amarin Investigational Site	Vancouver	British Columbia
India	Amarin Investigational Site	Bangalore	Karnataka
India	Amarin Investigational Site	Bangalore	Karnataka
India	Amarin Investigational Site	Bangalore	Karnataka
India	Amarin Investigational Site	Chennai	Tamil Nadu
India	Amarin Investigational Site	Coimbatore	Tamil Nadu
India	Amarin Investigational Site	Hyderabad	Andhra Pradesh
India	Amarin Investigational Site	Hyderabad	Andhra Pradesh
India	Amarin Investigational Site	Kottayam	Kerala
India	Amarin Investigational Site	Mumbai	Maharashtra
India	Amarin Investigational Site	Mysore	Karnataka
India	Amarin Investigational Site	Mysore	Karnataka
India	Amarin Investigational Site	Nashik	Maharashtra
India	Amarin Investigational Site	New Delhi	Delhi
India	Amarin Investigational Site	New Delhi	Delhi
India	Amarin Investigational Site	Pune	Maharashtra
India	Amarin Investigational Site	Secunderabad	Andhra Pradesh
India	Amarin Investigational Site	Visakhapatnam	Andhra Pradesh
Netherlands	Amarin Investigational Site	Almelo
Netherlands	Amarin Investigational Site	Amersfoort
Netherlands	Amarin Investigational Site	Blaricum
Netherlands	Amarin Investigational Site	Capelle aan den Ijssel
Netherlands	Amarin Investigational Site	Den Haag
Netherlands	Amarin Investigational Site	Den Helder
Netherlands	Amarin Investigational Site	Deventer
Netherlands	Amarin Investigational Site	Ede
Netherlands	Amarin Investigational Site	Eindhoven
Netherlands	Amarin Investigational Site	Enschede
Netherlands	Amarin Investigational Site	Goes
Netherlands	Amarin Investigational Site	Gorinchem
Netherlands	Amarin Investigational Site	Gouda
Netherlands	Amarin Investigational Site	Groningen
Netherlands	Amarin Investigational Site	Haarlem
Netherlands	Amarin Investigational Site	Harderwijk
Netherlands	Amarin Investigational Site	Heerenveen
Netherlands	Amarin Investigational Site	Heerlen
Netherlands	Amarin Investigational Site	Hoofddorp
Netherlands	Amarin Investigational Site	Leeuwarden
Netherlands	Amarin Investigational Site	Leiderdorp
Netherlands	Amarin Investigational Site	Nijmegen
Netherlands	Amarin Investigational Site	Roosendaal
Netherlands	Amarin Investigational Site	Rotterdam
Netherlands	Amarin Investigational Site	Rotterdam
Netherlands	Amarin Investigational Site	Rotterdam
Netherlands	Amarin Investigational Site	s'Hertogenbosch
Netherlands	Amarin Investigational Site	Schiedam
Netherlands	Amarin Investigational Site	Sneek
Netherlands	Amarin Investigational Site	Tilburg
Netherlands	Amarin Investigational Site	Tilburg
Netherlands	Amarin Investigational Site	Uden
Netherlands	Amarin Investigational Site	Veldhoven
Netherlands	Amarin Investigational Site	Zoetermeer
Netherlands	Amarin Investigational Site	Zutphen
New Zealand	Amarin Investigational Site	Christchurch
New Zealand	Amarin Investigational Site	Dunedin
New Zealand	Amarin Investigational Site	Hamilton
New Zealand	Amarin Investigational Site	Hastings
New Zealand	Amarin Investigational Site	Nelson
New Zealand	Amarin Investigational Site	New Plymouth
New Zealand	Amarin Investigational Site	Takapuna	Auckland
New Zealand	Amarin Investigational Site	Takapuna Auckland
New Zealand	Amarin Investigational Site	Tauranga
New Zealand	Amarin Investigational Site	Whangarei
Poland	Amarin Investigational Site	Bialystok
Poland	Amarin Investigational Site	Bialystok
Poland	Amarin Investigational Site	Katowice
Poland	Amarin Investigational Site	Katowice
Poland	Amarin Investigational Site	Kraków
Poland	Amarin Investigational Site	Mikolów
Poland	Amarin Investigational Site	Skierniewice
Poland	Amarin Investigational Site	Tarnów
Poland	Amarin Investigational Site	Warszawa
Poland	Amarin Investigational Site	Warszawa
Poland	Amarin Investigational Site	Warszawska
Poland	Amarin Investigational Site	Wroclaw
Poland	Amarin Investigational Site	Wroclaw
Poland	Amarin Investigational Site	Zgierz
Romania	Amarin Investigational Site	Arges
Romania	Amarin Investigational Site	Braila
Romania	Amarin Investigational Site	Bucharest
Romania	Amarin Investigational Site	Bucharest
Romania	Amarin Investigational Site	Bucharest
Romania	Amarin Investigational Site	Bucuresti
Romania	Amarin Investigational Site	Bucuresti
Romania	Amarin Investigational Site	Bucuresti
Romania	Amarin Investigational Site	Cluj-Napoca
Romania	Amarin Investigational Site	Constanta
Romania	Amarin Investigational Site	Craiova, Dolj
Romania	Amarin Investigational Site	Iasi
Romania	Amarin Investigational Site	Maramures
Romania	Amarin Investigational Site	Mures
Romania	Amarin Investigational Site	Sibiu
Romania	Amarin Investigational Site	Târgu Mures
Romania	Amarin Investigational Site	Timisoara
Russian Federation	Amarin Investigational Site	Arkhangelsk
Russian Federation	Amarin Investigational Site	Arkhangelsk
Russian Federation	Amarin Investigational Site	Arkhangelsk
Russian Federation	Amarin Investigational Site	Ekaterinburg
Russian Federation	Amarin Investigational Site	Ekaterinburg
Russian Federation	Amarin Investigational Site	Kazan
Russian Federation	Amarin Investigational Site	Kazan
Russian Federation	Amarin Investigational Site	Kemerovo
Russian Federation	Amarin Investigational Site	Kemerovo
Russian Federation	Amarin Investigational Site	Kirovsk, Leningradskaya Region
Russian Federation	Amarin Investigational Site	Krasnodar
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Moscow
Russian Federation	Amarin Investigational Site	Nizhny Novgorod
Russian Federation	Amarin Investigational Site	Novosibirsk
Russian Federation	Amarin Investigational Site	Novosibirsk
Russian Federation	Amarin Investigational Site	Novosibirsk
Russian Federation	Amarin Investigational Site	Petrozavodsk
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saint-Petersburg
Russian Federation	Amarin Investigational Site	Saratov
Russian Federation	Amarin Investigational Site	Saratov
Russian Federation	Amarin Investigational Site	Sestroretsk, Saint-Petersburg
Russian Federation	Amarin Investigational Site	Tomsk
Russian Federation	Amarin Investigational Site	Tomsk
Russian Federation	Amarin Investigational Site	Volgograd
Russian Federation	Amarin Investigational Site	Voronezh
Russian Federation	Amarin Investigational Site	Voronezh
Russian Federation	Amarin Investigational Site	Yaroslavl
Russian Federation	Amarin Investigational Site	Yaroslavl
South Africa	Amarin Investigational Site	Bellville	Western Cape
South Africa	Amarin Investigational Site	Benoni	Gauteng
South Africa	Amarin Investigational Site	Bloemfontein	Freestate
South Africa	Amarin Investigational Site	Cape Town	Western Cape
South Africa	Amarin Investigational Site	Durban	KwaZulu-Natal
South Africa	Amarin Investigational Site	Durbanville	Western Cape
South Africa	Amarin Investigational Site	Goodwood	Western Cape
South Africa	Amarin Investigational Site	Kraaifontein	Western Cape
South Africa	Amarin Investigational Site	Newlands	KwaZulu-Natal
South Africa	Amarin Investigational Site	Paarl	Western Cape
South Africa	Amarin Investigational Site	Panorama	Western Cape
South Africa	Amarin Investigational Site	Parow	Western Cape
South Africa	Amarin Investigational Site	Pinelands	Western Cape
South Africa	Amarin Investigational Site	Pretoria	Gauteng
South Africa	Amarin Investigational Site	Somerset West	Western Cape
South Africa	Amarin Investigational Site	Soweto	Gauteng
South Africa	Amarin Investigational Site	Witbank	Gauteng
South Africa	Amarin Investigational Site	Worcester	Western Cape
Ukraine	Amarin Investigational Site	Cherkasy
Ukraine	Amarin Investigational Site	Chernivtsi
Ukraine	Amarin Investigational Site	Dnipropetrovsk
Ukraine	Amarin Investigational Site	Dnipropetrovsk
Ukraine	Amarin Investigational Site	Dnipropetrovsk
Ukraine	Amarin Investigational Site	Donetsk
Ukraine	Amarin Investigational Site	Donetsk
Ukraine	Amarin Investigational Site	Ivano-Frankivsk
Ukraine	Amarin Investigational Site	Ivano-Frankivsk
Ukraine	Amarin Investigational Site	Kharkiv
Ukraine	Amarin Investigational Site	Kharkiv
Ukraine	Amarin Investigational Site	Kharkiv
Ukraine	Amarin Investigational Site	Kharkiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Kyiv
Ukraine	Amarin Investigational Site	Luhansk
Ukraine	Amarin Investigational Site	Lutsk
Ukraine	Amarin Investigational Site	Lutsk	Volyn Region
Ukraine	Amarin Investigational Site	Lviv
Ukraine	Amarin Investigational Site	Odesa
Ukraine	Amarin Investigational Site	Odesa
Ukraine	Amarin Investigational Site	Odesa
Ukraine	Amarin Investigational Site	Poltava
Ukraine	Amarin Investigational Site	Ternopil
Ukraine	Amarin Investigational Site	Uzhgorod
Ukraine	Amarin Investigational Site	Uzhgorod
Ukraine	Amarin Investigational Site	Vinnytsya
Ukraine	Amarin Investigational Site	Vinnytsya
Ukraine	Amarin Investigational Site	Zaporizhzhia
Ukraine	Amarin Investigational Site	Zaporizhzhia
Ukraine	Amarin Investigational Site	Zaporizhzhia
Ukraine	Amarin Investigational Site	Zaporizhzhia
United States	Amarin Investigational Site	Addison	Illinois
United States	Amarin Investigational Site	Albany	New York
United States	Amarin Investigational Site	Albuquerque	New Mexico
United States	Amarin Investigational Site	Alexandria	Louisiana
United States	Amarin Investigational Site	Auburn	Maine
United States	Amarin Investigational Site	Aurora	Colorado
United States	Amarin Investigational Site	Austin	Texas
United States	Amarin Investigational Site	Baltimore	Maryland
United States	Amarin Investigational Site	Beaumont	Texas
United States	Amarin Investigational Site	Beaver	Pennsylvania
United States	Amarin Investigational Site	Bend	Oregon
United States	Amarin Investigational Site	Beverly Hills	California
United States	Amarin Investigational Site	Biloxi	Mississippi
United States	Amarin Investigational Site	Birmingham	Alabama
United States	Amarin Investigational Site	Birmingham	Alabama
United States	Amarin Investigational Site	Boston	Massachusetts
United States	Amarin Investigational Site	Boston	Massachusetts
United States	Amarin Investigational Site	Boynton Beach	Florida
United States	Amarin Investigational Site	Bradenton	Florida
United States	Amarin Investigational Site	Bristol	Tennessee
United States	Amarin Investigational Site	Brooklyn	New York
United States	Amarin Investigational Site	Burien	Washington
United States	Amarin Investigational Site	Carrollton	Texas
United States	Amarin Investigational Site	Charlotte	North Carolina
United States	Amarin Investigational Site	Chesterfield	Missouri
United States	Amarin Investigational Site	Chicago	Illinois
United States	Amarin Investigational Site	Chino	California
United States	Amarin Investigational Site	Cincinnati	Ohio
United States	Amarin Investigational Site	Clearwater	Florida
United States	Amarin Investigational Site	Colorado Springs	Colorado
United States	Amarin Investigational Site	Columbia	Tennessee
United States	Amarin Investigational Site	Concord	California
United States	Amarin Investigational Site	Conyers	Georgia
United States	Amarin Investigational Site	Covington	Georgia
United States	Amarin Investigational Site	Cumming	Georgia
United States	Amarin Investigational Site	Dallas	Texas
United States	Amarin Investigational Site	Dayton	Ohio
United States	Amarin Investigational Site	Doylestown	Pennsylvania
United States	Amarin Investigational Site	Durham	North Carolina
United States	Amarin Investigational Site	Edgewater	Florida
United States	Amarin Investigational Site	El Cajon	California
United States	Amarin Investigational Site	Encino	California
United States	Amarin Investigational Site	Eunice	Louisiana
United States	Amarin Investigational Site	Evansville	Indiana
United States	Amarin Investigational Site	Fair Oaks	California
United States	Amarin Investigational Site	Fall River	Massachusetts
United States	Amarin Investigational Site	Falls Church	Virginia
United States	Amarin Investigational Site	Fargo	North Dakota
United States	Amarin Investigational Site	Fleming Island	Florida
United States	Amarin Investigational Site	Florissant	Missouri
United States	Amarin Investigational Site	Fort Lauderdale	Florida
United States	Amarin Investigational Site	Fort Lauderdale	Florida
United States	Amarin Investigational Site	Gastonia	North Carolina
United States	Amarin Investigational Site	Germantown	Tennessee
United States	Amarin Investigational Site	Golden	Colorado
United States	Amarin Investigational Site	Great Neck	New York
United States	Amarin Investigational Site	Guilford	Connecticut
United States	Amarin Investigational Site	Hartford	Connecticut
United States	Amarin Investigational Site	Hastings	Nebraska
United States	Amarin Investigational Site	Hawaiian Gardens	California
United States	Amarin Investigational Site	Henderson	Nevada
United States	Amarin Investigational Site	Honolulu	Hawaii
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Houston	Texas
United States	Amarin Investigational Site	Huntington	West Virginia
United States	Amarin Investigational Site	Huntsville	Alabama
United States	Amarin Investigational Site	Hurst	Texas
United States	Amarin Investigational Site	Inverness	Florida
United States	Amarin Investigational Site	Iowa City	Iowa
United States	Amarin Investigational Site	Jackson	Tennessee
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jacksonville	Florida
United States	Amarin Investigational Site	Jefferson City	Missouri
United States	Amarin Investigational Site	Jersey Shore	Pennsylvania
United States	Amarin Investigational Site	Kansas City	Missouri
United States	Amarin Investigational Site	Kernersville	North Carolina
United States	Amarin Investigational Site	Knoxville	Tennessee
United States	Amarin Investigational Site	Lancaster	South Carolina
United States	Amarin Investigational Site	Lancaster	California
United States	Amarin Investigational Site	Lansing	Michigan
United States	Amarin Investigational Site	Las Vegas	Nevada
United States	Amarin Investigational Site	Lincoln	California
United States	Amarin Investigational Site	Little Rock	Arkansas
United States	Amarin Investigational Site	Liverpool	New York
United States	Amarin Investigational Site	Lorain	Ohio
United States	Amarin Investigational Site	Los Angeles	California
United States	Amarin Investigational Site	Los Angeles	California
United States	Amarin Investigational Site	Los Angeles	California
United States	Amarin Investigational Site	Louisville	Kentucky
United States	Amarin Investigational Site	Lutherville	Maryland
United States	Amarin Investigational Site	Manassas	Virginia
United States	Amarin Investigational Site	Marquette	Michigan
United States	Amarin Investigational Site	Marrero	Louisiana
United States	Amarin Investigational Site	Mesa	Arizona
United States	Amarin Investigational Site	Miami	Florida
United States	Amarin Investigational Site	Miami	Florida
United States	Amarin Investigational Site	Miami Beach	Florida
United States	Amarin Investigational Site	Miami Lakes	Florida
United States	Amarin Investigational Site	Midlothian	Virginia
United States	Amarin Investigational Site	Mobile	Alabama
United States	Amarin Investigational Site	Muscle Shoals	Alabama
United States	Amarin Investigational Site	National City	California
United States	Amarin Investigational Site	New Braunfels	Texas
United States	Amarin Investigational Site	New York	New York
United States	Amarin Investigational Site	New York	New York
United States	Amarin Investigational Site	Newark	Delaware
United States	Amarin Investigational Site	Newport	Pennsylvania
United States	Amarin Investigational Site	Newport News	Virginia
United States	Amarin Investigational Site	Norman	Illinois
United States	Amarin Investigational Site	North Chicago	Illinois
United States	Amarin Investigational Site	North Massapequa	New York
United States	Amarin Investigational Site	Ocala	Florida
United States	Amarin Investigational Site	Ocean City	New Jersey
United States	Amarin Investigational Site	Omaha	Nebraska
United States	Amarin Investigational Site	Omaha	Nebraska
United States	Amarin Investigational Site	Orange	California
United States	Amarin Investigational Site	Orlando	Florida
United States	Amarin Investigational Site	Paramount	California
United States	Amarin Investigational Site	Pembroke Pines	Florida
United States	Amarin Investigational Site	Peoria	Illinois
United States	Amarin Investigational Site	Philadelphia	Pennsylvania
United States	Amarin Investigational Site	Phoenix	Arizona
United States	Amarin Investigational Site	Phoenixville	Pennsylvania
United States	Amarin Investigational Site	Plano	Texas
United States	Amarin Investigational Site	Plantation	Florida
United States	Amarin Investigational Site	Portland	Oregon
United States	Amarin Investigational Site	Raleigh	North Carolina
United States	Amarin Investigational Site	Rapid City	South Dakota
United States	Amarin Investigational Site	Roseville	California
United States	Amarin Investigational Site	Roswell	Georgia
United States	Amarin Investigational Site	Safety Harbor	Florida
United States	Amarin Investigational Site	Saint Cloud	Minnesota
United States	Amarin Investigational Site	Saint Louis	Missouri
United States	Amarin Investigational Site	Saint Peters	Missouri
United States	Amarin Investigational Site	Saint Petersburg	Florida
United States	Amarin Investigational Site	San Antonio	Texas
United States	Amarin Investigational Site	San Antonio	Texas
United States	Amarin Investigational Site	San Diego	California
United States	Amarin Investigational Site	Sandusky	Ohio
United States	Amarin Investigational Site	Sarasota	Florida
United States	Amarin Investigational Site	Sellersville	Pennsylvania
United States	Amarin Investigational Site	Simpsonville	South Carolina
United States	Amarin Investigational Site	Smithtown	New York
United States	Amarin Investigational Site	Smyrna	Tennessee
United States	Amarin Investigational Site	Splendora	Texas
United States	Amarin Investigational Site	Tacoma	Washington
United States	Amarin Investigational Site	Takoma Park	Maryland
United States	Amarin Investigational Site	Tipton	Pennsylvania
United States	Amarin Investigational Site	Tomball	Texas
United States	Amarin Investigational Site	Torrance	California
United States	Amarin Investigational Site	Troy	Michigan
United States	Amarin Investigational Site	Tucson	Arizona
United States	Amarin Investigational Site	Tulsa	Oklahoma
United States	Amarin Investigational Site	Tupelo	Mississippi
United States	Amarin Investigational Site	Ventura	California
United States	Amarin Investigational Site	Vero Beach	Florida
United States	Amarin Investigational Site	Vestal	New York
United States	Amarin Investigational Site	Walnut Creek	California
United States	Amarin Investigational Site	Washington	District of Columbia
United States	Amarin Investigational Site	West Jordan	Utah
United States	Amarin Investigational Site	West Palm Beach	Florida
United States	Amarin Investigational Site	West Seneca	New York
United States	Amarin Investigational Site	Wichita	Kansas
United States	Amarin Investigational Site	Wichita	Kansas
United States	Amarin Investigational Site	Wilmington	Delaware
United States	Amarin Investigational Site	Winfield	Illinois
United States	Amarin Investigational Site	Winston-Salem	North Carolina
United States	Amarin Investigational Site	Wyomissing	Pennsylvania
United States	Amarin Investigational Site	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Amarin Pharma Inc.

Countries where clinical trial is conducted

United States,  Australia,  Canada,  India,  Netherlands,  New Zealand,  Poland,  Romania,  Russian Federation,  South Africa,  Ukraine, 

References & Publications (11)

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 3 — View Citation

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. — View Citation

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 Cardi — View Citation

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. 2 — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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 — View Citation

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 Revasculariz — View Citation

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- — View Citation

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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Total follow-up time of up to approximately 6 years.
Secondary	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.	Total follow-up time of up to approximately 6 years.
Secondary	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.	Total follow-up time of up to approximately 6 years.
Secondary	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.	Total follow-up time of up to approximately 6 years.
Secondary	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.	Total follow-up time of up to approximately 6 years.
Secondary	CV Death.	Number of patients with an occurrence of CV death during the follow-up period.	Total follow-up time of up to approximately 6 years.
Secondary	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.	Total follow-up time of up to approximately 6 years.
Secondary	Fatal or Nonfatal Stroke.	Number of patients with a first occurrence of fatal or nonfatal stroke during the follow-up period.	Total follow-up time of up to approximately 6 years.
Secondary	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 follow-up time of up to approximately 6 years.
Secondary	Total Mortality.	Number of patients with an occurrence of death from any cause during the follow-up period.	Total follow-up time of up to approximately 6 years.