A Study of AMR101 to Evaluate Its Ability to Reduce Cardiovascular Events in High-Risk Patients With Hypertriglyceridemia and on Statin
REDUCE-IT
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)
1 other identifier
interventional
8,179
11 countries
410
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 cardiovascular-diseases
Started Nov 2011
Typical duration for phase_3 cardiovascular-diseases
410 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2011
CompletedFirst Submitted
Initial submission to the registry
December 13, 2011
CompletedFirst Posted
Study publicly available on registry
December 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2018
CompletedResults Posted
Study results publicly available
April 14, 2022
CompletedApril 14, 2022
March 1, 2022
6.5 years
December 13, 2011
February 8, 2022
March 21, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Composite of CV Death, Nonfatal MI (Including Silent MI), or Nonfatal Stroke.
Total follow-up time of up to approximately 6 years.
Composite of CV Death or Nonfatal MI (Including Silent MI).
Total follow-up time of up to approximately 6 years.
Fatal or Nonfatal MI (Including Silent MI).
Total follow-up time of up to approximately 6 years.
Non-elective Coronary Revascularization Represented as the Composite of Emergent or Urgent Classifications.
Total follow-up time of up to approximately 6 years.
CV Death.
Total follow-up time of up to approximately 6 years.
- +4 more secondary outcomes
Study Arms (2)
AMR101
EXPERIMENTALAMR101 (icosapent ethyl) + statin therapy, daily
Placebo
PLACEBO COMPARATORPlacebo + statin therapy, daily
Interventions
Stable statin therapy (± ezetimibe) for at least 28 days before lipid qualification measurement (LDL-C \>40 mg/dL and ≤100 mg/dL)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (410)
Amarin Investigational Site
Birmingham, Alabama, 35205, United States
Amarin Investigational Site
Birmingham, Alabama, 35235, United States
Amarin Investigational Site
Huntsville, Alabama, 35801, United States
Amarin Investigational Site
Mobile, Alabama, 36608, United States
Amarin Investigational Site
Muscle Shoals, Alabama, 35662, United States
Amarin Investigational Site
Mesa, Arizona, 85206, United States
Amarin Investigational Site
Phoenix, Arizona, 85251, United States
Amarin Investigational Site
Tucson, Arizona, 85745, United States
Amarin Investigational Site
Little Rock, Arkansas, 72204, United States
Amarin Investigational Site
Beverly Hills, California, 90211, United States
Amarin Investigational Site
Chino, California, 91710, United States
Amarin Investigational Site
Concord, California, 94520, United States
Amarin Investigational Site
El Cajon, California, 92020, United States
Amarin Investigational Site
Encino, California, 91436, United States
Amarin Investigational Site
Fair Oaks, California, 95628, United States
Amarin Investigational Site
Hawaiian Gardens, California, 90716, United States
Amarin Investigational Site
Lancaster, California, 93534, United States
Amarin Investigational Site
Lincoln, California, 95648, United States
Amarin Investigational Site
Los Angeles, California, 90015, United States
Amarin Investigational Site
Los Angeles, California, 90017, United States
Amarin Investigational Site
Los Angeles, California, 90033, United States
Amarin Investigational Site
National City, California, 91950, United States
Amarin Investigational Site
Orange, California, 92868, United States
Amarin Investigational Site
Paramount, California, 90723, United States
Amarin Investigational Site
Roseville, California, 95661, United States
Amarin Investigational Site
San Diego, California, 92123, United States
Amarin Investigational Site
Torrance, California, 90502, United States
Amarin Investigational Site
Ventura, California, 93003, United States
Amarin Investigational Site
Walnut Creek, California, 94598, United States
Amarin Investigational Site
Aurora, Colorado, 80012, United States
Amarin Investigational Site
Colorado Springs, Colorado, 80909, United States
Amarin Investigational Site
Golden, Colorado, 80401, United States
Amarin Investigational Site
Guilford, Connecticut, 06437, United States
Amarin Investigational Site
Hartford, Connecticut, 06102, United States
Amarin Investigational Site
Newark, Delaware, 19718, United States
Amarin Investigational Site
Wilmington, Delaware, 19803, United States
Amarin Investigational Site
Washington D.C., District of Columbia, 20037, United States
Amarin Investigational Site
Boynton Beach, Florida, 33437, United States
Amarin Investigational Site
Bradenton, Florida, 34209, United States
Amarin Investigational Site
Clearwater, Florida, 33756, United States
Amarin Investigational Site
Edgewater, Florida, 32132, United States
Amarin Investigational Site
Fleming Island, Florida, 32003, United States
Amarin Investigational Site
Fort Lauderdale, Florida, 33308, United States
Amarin Investigational Site
Fort Lauderdale, Florida, 33312, United States
Amarin Investigational Site
Inverness, Florida, 34429, United States
Amarin Investigational Site
Jacksonville, Florida, 32204, United States
Amarin Investigational Site
Jacksonville, Florida, 32205, United States
Amarin Investigational Site
Jacksonville, Florida, 32207, United States
Amarin Investigational Site
Jacksonville, Florida, 32216, United States
Amarin Investigational Site
Miami, Florida, 33144, United States
Amarin Investigational Site
Miami, Florida, 33175, United States
Amarin Investigational Site
Miami Beach, Florida, 33140, United States
Amarin Investigational Site
Miami Lakes, Florida, 33014, United States
Amarin Investigational Site
Ocala, Florida, 34471, United States
Amarin Investigational Site
Orlando, Florida, 32803, United States
Amarin Investigational Site
Pembroke Pines, Florida, 33026, United States
Amarin Investigational Site
Plantation, Florida, 33324, United States
Amarin Investigational Site
Safety Harbor, Florida, 34695, United States
Amarin Investigational Site
Sarasota, Florida, 34233, United States
Amarin Investigational Site
St. Petersburg, Florida, 33713, United States
Amarin Investigational Site
Vero Beach, Florida, 32960, United States
Amarin Investigational Site
West Palm Beach, Florida, 33401, United States
Amarin Investigational Site
Conyers, Georgia, 30094, United States
Amarin Investigational Site
Covington, Georgia, 30014, United States
Amarin Investigational Site
Cumming, Georgia, 30041, United States
Amarin Investigational Site
Roswell, Georgia, 30076, United States
Amarin Investigational Site
Honolulu, Hawaii, 96818, United States
Amarin Investigational Site
Addison, Illinois, 60101, United States
Amarin Investigational Site
Chicago, Illinois, 60611, United States
Amarin Investigational Site
Norman, Illinois, 61761, United States
Amarin Investigational Site
North Chicago, Illinois, 60064, United States
Amarin Investigational Site
Peoria, Illinois, 61636, United States
Amarin Investigational Site
Winfield, Illinois, 60190, United States
Amarin Investigational Site
Evansville, Indiana, 47713, United States
Amarin Investigational Site
Iowa City, Iowa, 52242, United States
Amarin Investigational Site
Wichita, Kansas, 67203, United States
Amarin Investigational Site
Wichita, Kansas, 67207, United States
Amarin Investigational Site
Louisville, Kentucky, 40213, United States
Amarin Investigational Site
Alexandria, Louisiana, 71301, United States
Amarin Investigational Site
Eunice, Louisiana, 70535, United States
Amarin Investigational Site
Marrero, Louisiana, 70072, United States
Amarin Investigational Site
Auburn, Maine, 04210, United States
Amarin Investigational Site
Baltimore, Maryland, 21236, United States
Amarin Investigational Site
Lutherville, Maryland, 21093, United States
Amarin Investigational Site
Takoma Park, Maryland, 20912, United States
Amarin Investigational Site
Boston, Massachusetts, 02118, United States
Amarin Investigational Site
Boston, Massachusetts, 02215, United States
Amarin Investigational Site
Fall River, Massachusetts, 02721, United States
Amarin Investigational Site
Lansing, Michigan, 48910, United States
Amarin Investigational Site
Marquette, Michigan, 49855, United States
Amarin Investigational Site
Troy, Michigan, 48098, United States
Amarin Investigational Site
Saint Cloud, Minnesota, 56303, United States
Amarin Investigational Site
Biloxi, Mississippi, 39531, United States
Amarin Investigational Site
Tupelo, Mississippi, 38801, United States
Amarin Investigational Site
Chesterfield, Missouri, 63141, United States
Amarin Investigational Site
City of Saint Peters, Missouri, 63303, United States
Amarin Investigational Site
Florissant, Missouri, 63031, United States
Amarin Investigational Site
Jefferson City, Missouri, 65109, United States
Amarin Investigational Site
Kansas City, Missouri, 64114, United States
Amarin Investigational Site
St Louis, Missouri, 63110, United States
Amarin Investigational Site
Hastings, Nebraska, 68901, United States
Amarin Investigational Site
Omaha, Nebraska, 68114, United States
Amarin Investigational Site
Omaha, Nebraska, 68154, United States
Amarin Investigational Site
Henderson, Nevada, 89052, United States
Amarin Investigational Site
Las Vegas, Nevada, 89101, United States
Amarin Investigational Site
Ocean City, New Jersey, 07712, United States
Amarin Investigational Site
Albuquerque, New Mexico, 87102, United States
Amarin Investigational Site
Albany, New York, 12206, United States
Amarin Investigational Site
Brooklyn, New York, 11206, United States
Amarin Investigational Site
Great Neck, New York, 11023, United States
Amarin Investigational Site
Liverpool, New York, 13088, United States
Amarin Investigational Site
New York, New York, 10001, United States
Amarin Investigational Site
New York, New York, 10016, United States
Amarin Investigational Site
North Massapequa, New York, 11758, United States
Amarin Investigational Site
Smithtown, New York, 11787, United States
Amarin Investigational Site
Vestal, New York, 13850, United States
Amarin Investigational Site
West Seneca, New York, 14224, United States
Amarin Investigational Site
Charlotte, North Carolina, 28204, United States
Amarin Investigational Site
Durham, North Carolina, 27710, United States
Amarin Investigational Site
Gastonia, North Carolina, 28054, United States
Amarin Investigational Site
Kernersville, North Carolina, 27284, United States
Amarin Investigational Site
Raleigh, North Carolina, 27609, United States
Amarin Investigational Site
Winston-Salem, North Carolina, 27157, United States
Amarin Investigational Site
Fargo, North Dakota, 58103, United States
Amarin Investigational Site
Cincinnati, Ohio, 45219, United States
Amarin Investigational Site
Dayton, Ohio, 45419, United States
Amarin Investigational Site
Lorain, Ohio, 44053, United States
Amarin Investigational Site
Sandusky, Ohio, 44870, United States
Amarin Investigational Site
Tulsa, Oklahoma, 74104, United States
Amarin Investigational Site
Bend, Oregon, 97702, United States
Amarin Investigational Site
Portland, Oregon, 97239, United States
Amarin Investigational Site
Beaver, Pennsylvania, 15009, United States
Amarin Investigational Site
Doylestown, Pennsylvania, 18901, United States
Amarin Investigational Site
Jersey Shore, Pennsylvania, 17740, United States
Amarin Investigational Site
Newport, Pennsylvania, 17074, United States
Amarin Investigational Site
Philadelphia, Pennsylvania, 19104, United States
Amarin Investigational Site
Phoenixville, Pennsylvania, 19460, United States
Amarin Investigational Site
Sellersville, Pennsylvania, 18960, United States
Amarin Investigational Site
Tipton, Pennsylvania, 16684, United States
Amarin Investigational Site
Wyomissing, Pennsylvania, 19610, United States
Amarin Investigational Site
Yardley, Pennsylvania, 19067, United States
Amarin Investigational Site
Lancaster, South Carolina, 29720, United States
Amarin Investigational Site
Simpsonville, South Carolina, 29681, United States
Amarin Investigational Site
Rapid City, South Dakota, 57701, United States
Amarin Investigational Site
Bristol, Tennessee, 37620, United States
Amarin Investigational Site
Columbia, Tennessee, 38401, United States
Amarin Investigational Site
Germantown, Tennessee, 38138, United States
Amarin Investigational Site
Jackson, Tennessee, 38301, United States
Amarin Investigational Site
Knoxville, Tennessee, 37917, United States
Amarin Investigational Site
Smyrna, Tennessee, 37167, United States
Amarin Investigational Site
Austin, Texas, 78756, United States
Amarin Investigational Site
Beaumont, Texas, 77702, United States
Amarin Investigational Site
Carrollton, Texas, 75007, United States
Amarin Investigational Site
Dallas, Texas, 75231, United States
Amarin Investigational Site
Houston, Texas, 77024, United States
Amarin Investigational Site
Houston, Texas, 77025, United States
Amarin Investigational Site
Houston, Texas, 77030, United States
Amarin Investigational Site
Houston, Texas, 77053, United States
Amarin Investigational Site
Houston, Texas, 77070, United States
Amarin Investigational Site
Houston, Texas, 77077, United States
Amarin Investigational Site
Houston, Texas, 77079, United States
Amarin Investigational Site
Hurst, Texas, 76054, United States
Amarin Investigational Site
New Braunfels, Texas, 78130, United States
Amarin Investigational Site
Plano, Texas, 75075, United States
Amarin Investigational Site
San Antonio, Texas, 78228, United States
Amarin Investigational Site
San Antonio, Texas, 78238, United States
Amarin Investigational Site
Splendora, Texas, 77372, United States
Amarin Investigational Site
Tomball, Texas, 77375, United States
Amarin Investigational Site
West Jordan, Utah, 84088, United States
Amarin Investigational Site
Falls Church, Virginia, 22044, United States
Amarin Investigational Site
Manassas, Virginia, 20109, United States
Amarin Investigational Site
Midlothian, Virginia, 23114, United States
Amarin Investigational Site
Newport News, Virginia, 23606, United States
Amarin Investigational Site
Burien, Washington, 98166, United States
Amarin Investigational Site
Tacoma, Washington, 98405, United States
Amarin Investigational Site
Huntington, West Virginia, 25701, United States
Amarin Investigational Site
Camperdown, New South Wales, 2015, Australia
Amarin Investigational Site
Lismore, New South Wales, 2480, Australia
Amarin Investigational Site
Brisbane, Queensland, 4064, Australia
Amarin Investigational Site
Chermside, Queensland, 4032, Australia
Amarin Investigational Site
Bedford Park, South Australia, 5042, Australia
Amarin Investigational Site
Launceston, Tasmania, 7250, Australia
Amarin Investigational Site
Fitzroy, Victoria, 3065, Australia
Amarin Investigational Site
Geelong, Victoria, 3220, Australia
Amarin Investigational Site
Heidelberg Heights, Victoria, 3081, Australia
Amarin Investigational Site
Melbourne, Victoria, 3004, Australia
Amarin Investigational Site
Fremantle, Western Australia, 6160, Australia
Amarin Investigational Site
Joondalup, Western Australia, 6027, Australia
Amarin Investigational Site
Murdoch, Western Australia, 6150, Australia
Amarin Investigational Site
Nedlands, Western Australia, 6009, Australia
Amarin Investigational Site
Perth, Western Australia, 6000, Australia
Amarin Investigational Site
Edmonton, Alberta, T5A 4L8, Canada
Amarin Investigational Site
Coquitlam, British Columbia, V3K 3V9, Canada
Amarin Investigational Site
Vancouver, British Columbia, V5Z 1M9, Canada
Amarin Investigational Site
Vancouver, British Columbia, V6Z1Y6, Canada
Amarin Investigational Site
Brampton, Ontario, L6Z 4N5, Canada
Amarin Investigational Site
Collingwood, Ontario, L9Y 1W3, Canada
Amarin Investigational Site
Corunna, Ontario, N0N 1G0, Canada
Amarin Investigational Site
Newmarket, Ontario, L3Y 5G8, Canada
Amarin Investigational Site
Sarnia, Ontario, N7T 4X3, Canada
Amarin Investigational Site
Strathroy, Ontario, N7G 1Y7, Canada
Amarin Investigational Site
Laval, Quebec, H7T 2P5, Canada
Amarin Investigational Site
Montreal, Quebec, H1T 1C8, Canada
Amarin Investigational Site
Montreal, Quebec, H3H 1A1, Canada
Amarin Investigational Site
Saint-Charles-Borromée, Quebec, J6E 6J2, Canada
Amarin Investigational Site
Sherbrooke, Quebec, J1J 2E3, Canada
Amarin Investigational Site
Québec, G1V 4G5, Canada
Amarin Investigational Site
Québec, G1V 4M6, Canada
Amarin Investigational Site
Hyderabad, Andhra Pradesh, 500001, India
Amarin Investigational Site
Hyderabad, Andhra Pradesh, 500004, India
Amarin Investigational Site
Secunderabad, Andhra Pradesh, 500003, India
Amarin Investigational Site
Visakhapatnam, Andhra Pradesh, 530013, India
Amarin Investigational Site
Bangalore, Karnataka, 560034, India
Amarin Investigational Site
Bangalore, Karnataka, 560038, India
Amarin Investigational Site
Bangalore, Karnataka, 560052, India
Amarin Investigational Site
Mysore, Karnataka, 570015, India
Amarin Investigational Site
Mysore, Karnataka, 570020, India
Amarin Investigational Site
Kottayam, Kerala, 686016, India
Amarin Investigational Site
Mumbai, Maharashtra, 422055, India
Amarin Investigational Site
Nashik, Maharashtra, 422005, India
Amarin Investigational Site
Pune, Maharashtra, 411004, India
Amarin Investigational Site
New Delhi, National Capital Territory of Delhi, 110025, India
Amarin Investigational Site
New Delhi, National Capital Territory of Delhi, 110060, India
Amarin Investigational Site
Chennai, Tamil Nadu, 600086, India
Amarin Investigational Site
Coimbatore, Tamil Nadu, 641037, India
Amarin Investigational Site
Almelo, 7600 SZ, Netherlands
Amarin Investigational Site
Amersfoort, 3813 TZ, Netherlands
Amarin Investigational Site
Blaricum, 1261 AN, Netherlands
Amarin Investigational Site
Capelle aan den IJssel, 2906 ZC, Netherlands
Amarin Investigational Site
Den Helder, 1782 GZ, Netherlands
Amarin Investigational Site
Deventer, 7416 SE, Netherlands
Amarin Investigational Site
Ede, 6716 RP, Netherlands
Amarin Investigational Site
Eindhoven, 5611 NV, Netherlands
Amarin Investigational Site
Enschede, 7513 ER, Netherlands
Amarin Investigational Site
Goes, 4462 RA, Netherlands
Amarin Investigational Site
Gorinchem, 4204 AA, Netherlands
Amarin Investigational Site
Gouda, 2803 HH, Netherlands
Amarin Investigational Site
Groningen, 9728 NT, Netherlands
Amarin Investigational Site
Haarlem, 2035 RC, Netherlands
Amarin Investigational Site
Harderwijk, 3844 DG, Netherlands
Amarin Investigational Site
Heerenveen, 8441 PW, Netherlands
Amarin Investigational Site
Heerlen, 6419 PC, Netherlands
Amarin Investigational Site
Hoofddorp, 2134 TM, Netherlands
Amarin Investigational Site
Leeuwarden, 8934 AD, Netherlands
Amarin Investigational Site
Leiderdorp, 2353 GA, Netherlands
Amarin Investigational Site
Nijmegen, 6532 SZ, Netherlands
Amarin Investigational Site
Roosendaal, 4708 AE, Netherlands
Amarin Investigational Site
Rotterdam, 3021 HC, Netherlands
Amarin Investigational Site
Rotterdam, 3045 PM, Netherlands
Amarin Investigational Site
Rotterdam, 3083 AN, Netherlands
Amarin Investigational Site
s'Hertogenbosch, 5223 GV, Netherlands
Amarin Investigational Site
Schiedam, 3118 JH, Netherlands
Amarin Investigational Site
Sneek, 8601 ZK, Netherlands
Amarin Investigational Site
The Hague, 2597 AX, Netherlands
Amarin Investigational Site
Tilburg, 5022 GC, Netherlands
Amarin Investigational Site
Tilburg, 5042 AD, Netherlands
Amarin Investigational Site
Uden, 5406 PT, Netherlands
Amarin Investigational Site
Veldhoven, 5504 DB, Netherlands
Amarin Investigational Site
Zoetermeer, 2725 NA, Netherlands
Amarin Investigational Site
Zutphen, 7207 AE, Netherlands
Amarin Investigational Site
Takapuna, Auckland, 0622, New Zealand
Amarin Investigational Site
Christchurch, 8011, New Zealand
Amarin Investigational Site
Dunedin, 9016, New Zealand
Amarin Investigational Site
Hamilton, 3240, New Zealand
Amarin Investigational Site
Hastings, 4120, New Zealand
Amarin Investigational Site
Nelson, 7010, New Zealand
Amarin Investigational Site
New Plymouth, 4342, New Zealand
Amarin Investigational Site
Takapuna Auckland, 0622, New Zealand
Amarin Investigational Site
Tauranga, 3112, New Zealand
Amarin Investigational Site
Whangarei, 0110, New Zealand
Amarin Investigational Site
Bialystok, 15-351, Poland
Amarin Investigational Site
Bialystok, 15-875, Poland
Amarin Investigational Site
Katowice, 40-748, Poland
Amarin Investigational Site
Katowice, 40-772, Poland
Amarin Investigational Site
Krakow, 31-011, Poland
Amarin Investigational Site
MikolĂ³w, 43-190, Poland
Amarin Investigational Site
Skierniewice, 96-100, Poland
Amarin Investigational Site
TarnĂ³w, 33-100, Poland
Amarin Investigational Site
Warsaw, 01-231, Poland
Amarin Investigational Site
Warsaw, 04-628, Poland
Amarin Investigational Site
Warszawska, 01-192, Poland
Amarin Investigational Site
Wroclaw, 50-088, Poland
Amarin Investigational Site
Wroclaw, 50-315, Poland
Amarin Investigational Site
Zgierz, 95-100, Poland
Amarin Investigational Site
ArgeÅŸ, 110084, Romania
Amarin Investigational Site
Brăila, 810249, Romania
Amarin Investigational Site
Bucharest, 010628, Romania
Amarin Investigational Site
Bucharest, 011234, Romania
Amarin Investigational Site
Bucharest, 0200054, Romania
Amarin Investigational Site
Bucharest, 050098, Romania
Amarin Investigational Site
Bucharest, 050524, Romania
Amarin Investigational Site
Bucharest, 061098, Romania
Amarin Investigational Site
Cluj-Napoca, 400006, Romania
Amarin Investigational Site
Constanța, 900203, Romania
Amarin Investigational Site
Craiova, Dolj, 200030, Romania
Amarin Investigational Site
Iași, 700661, Romania
Amarin Investigational Site
MaramureÅŸ, 430123, Romania
Amarin Investigational Site
MureÅŸ, 540098, Romania
Amarin Investigational Site
Sibiu, 550245, Romania
Amarin Investigational Site
TĂ¢rgu MureÅŸ, 540136, Romania
Amarin Investigational Site
Timișoara, 300359, Romania
Amarin Investigational Site
Arkhangelsk, 163000, Russia
Amarin Investigational Site
Arkhangelsk, 163001, Russia
Amarin Investigational Site
Arkhangelsk, 163045, Russia
Amarin Investigational Site
Kazan', 420012, Russia
Amarin Investigational Site
Kazan', 420097, Russia
Amarin Investigational Site
Kemerovo, 650000, Russia
Amarin Investigational Site
Kemerovo, 650002, Russia
Amarin Investigational Site
Kirovsk, Leningradskaya Region, 187342, Russia
Amarin Investigational Site
Krasnodar, 350086, Russia
Amarin Investigational Site
Moscow, 109240, Russia
Amarin Investigational Site
Moscow, 111020, Russia
Amarin Investigational Site
Moscow, 111539, Russia
Amarin Investigational Site
Moscow, 115093, Russia
Amarin Investigational Site
Moscow, 117292, Russia
Amarin Investigational Site
Moscow, 117593, Russia
Amarin Investigational Site
Moscow, 117630, Russia
Amarin Investigational Site
Moscow, 117997, Russia
Amarin Investigational Site
Moscow, 121374, Russia
Amarin Investigational Site
Moscow, 121552, Russia
Amarin Investigational Site
Moscow, 124489, Russia
Amarin Investigational Site
Nizhny Novgorod, 603126, Russia
Amarin Investigational Site
Novosibirsk, 630008, Russia
Amarin Investigational Site
Novosibirsk, 630047, Russia
Amarin Investigational Site
Novosibirsk, 630089, Russia
Amarin Investigational Site
Petrozavodsk, 185000, Russia
Amarin Investigational Site
Saint Petersburg, 190000, Russia
Amarin Investigational Site
Saint Petersburg, 190107, Russia
Amarin Investigational Site
Saint Petersburg, 192283, Russia
Amarin Investigational Site
Saint Petersburg, 194044, Russia
Amarin Investigational Site
Saint Petersburg, 194156, Russia
Amarin Investigational Site
Saint Petersburg, 194291, Russia
Amarin Investigational Site
Saint Petersburg, 194354, Russia
Amarin Investigational Site
Saint Petersburg, 196601, Russia
Amarin Investigational Site
Saint Petersburg, 197022, Russia
Amarin Investigational Site
Saint Petersburg, 197110, Russia
Amarin Investigational Site
Saint Petersburg, 197227, Russia
Amarin Investigational Site
Saint Petersburg, 197341, Russia
Amarin Investigational Site
Saint Petersburg, 197729, Russia
Amarin Investigational Site
Saint Petersburg, 198205, Russia
Amarin Investigational Site
Saint Petersburg, 199106, Russia
Amarin Investigational Site
Saratov, 410002, Russia
Amarin Investigational Site
Saratov, 410028, Russia
Amarin Investigational Site
Sestroretsk, Saint-Petersburg, 197706, Russia
Amarin Investigational Site
Tomsk, 634050, Russia
Amarin Investigational Site
Tomsk, 643012, Russia
Amarin Investigational Site
Volgograd, 400001, Russia
Amarin Investigational Site
Voronezh, 394018, Russia
Amarin Investigational Site
Voronezh, 394065, Russia
Amarin Investigational Site
Yaroslavl, 150030, Russia
Amarin Investigational Site
Yaroslavl, 150062, Russia
Amarin Investigational Site
Yekaterinburg, 620102, Russia
Amarin Investigational Site
Yekaterinburg, 620109, Russia
Amarin Investigational Site
Bloemfontein, Freestate, 9301, South Africa
Amarin Investigational Site
Benoni, Gauteng, 1500, South Africa
Amarin Investigational Site
Pretoria, Gauteng, 0157, South Africa
Amarin Investigational Site
Soweto, Gauteng, 2013, South Africa
Amarin Investigational Site
Witbank, Gauteng, 1035, South Africa
Amarin Investigational Site
Durban, KwaZulu-Natal, 4001, South Africa
Amarin Investigational Site
Newlands, KwaZulu-Natal, 4037, South Africa
Amarin Investigational Site
Bellville, Western Cape, 7530, South Africa
Amarin Investigational Site
Cape Town, Western Cape, 7925, South Africa
Amarin Investigational Site
Durbanville, Western Cape, 7550, South Africa
Amarin Investigational Site
Goodwood, Western Cape, 7460, South Africa
Amarin Investigational Site
Kraaifontein, Western Cape, 7570, South Africa
Amarin Investigational Site
Paarl, Western Cape, 7646, South Africa
Amarin Investigational Site
Panorama, Western Cape, 7500, South Africa
Amarin Investigational Site
Parow, Western Cape, 7500, South Africa
Amarin Investigational Site
Pinelands, Western Cape, 7405, South Africa
Amarin Investigational Site
Somerset West, Western Cape, 7130, South Africa
Amarin Investigational Site
Worcester, Western Cape, 6850, South Africa
Amarin Investigational Site
Lutsk, Volyn Oblast, 43000, Ukraine
Amarin Investigational Site
Cherkasy, 18009, Ukraine
Amarin Investigational Site
Chernivtsi, 58002, Ukraine
Amarin Investigational Site
Dnipropetrovsk, 49006, Ukraine
Amarin Investigational Site
Dnipropetrovsk, 49023, Ukraine
Amarin Investigational Site
Dnipropetrovsk, 49027, Ukraine
Amarin Investigational Site
Donetsk, 83001, Ukraine
Amarin Investigational Site
Donetsk, 83045, Ukraine
Amarin Investigational Site
Ivano-Frankivsk, 76005, Ukraine
Amarin Investigational Site
Ivano-Frankivsk, 76018, Ukraine
Amarin Investigational Site
Kharkiv, 61002, Ukraine
Amarin Investigational Site
Kharkiv, 61018, Ukraine
Amarin Investigational Site
Kharkiv, 61039, Ukraine
Amarin Investigational Site
Kharkiv, 61176, Ukraine
Amarin Investigational Site
Kyiv, 01032, Ukraine
Amarin Investigational Site
Kyiv, 01103, Ukraine
Amarin Investigational Site
Kyiv, 01151, Ukraine
Amarin Investigational Site
Kyiv, 01601, Ukraine
Amarin Investigational Site
Kyiv, 02091, Ukraine
Amarin Investigational Site
Kyiv, 02660, Ukraine
Amarin Investigational Site
Kyiv, 03151, Ukraine
Amarin Investigational Site
Kyiv, 04050, Ukraine
Amarin Investigational Site
Kyiv, 04114, Ukraine
Amarin Investigational Site
Luhansk, 91016, Ukraine
Amarin Investigational Site
Lutsk, 43024, Ukraine
Amarin Investigational Site
Lviv, 79034, Ukraine
Amarin Investigational Site
Odesa, 65009, Ukraine
Amarin Investigational Site
Odesa, 65025, Ukraine
Amarin Investigational Site
Odesa, 65082, Ukraine
Amarin Investigational Site
Poltava, 36011, Ukraine
Amarin Investigational Site
Ternopil, 46003, Ukraine
Amarin Investigational Site
Uzhhorod, 88000, Ukraine
Amarin Investigational Site
Uzhhorod, 88014, Ukraine
Amarin Investigational Site
Vinnytsia, 21018, Ukraine
Amarin Investigational Site
Vinnytsia, 21029, Ukraine
Amarin Investigational Site
Zaporizhzhia, 69035, Ukraine
Amarin Investigational Site
Zaporizhzhia, 69065, Ukraine
Amarin Investigational Site
Zaporizhzhia, 69106, Ukraine
Amarin Investigational Site
Zaporizhzhia, 69600, Ukraine
Related Publications (20)
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.
PMID: 28294373BACKGROUNDBhatt 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.
PMID: 30415628RESULTBhatt 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.
PMID: 30898607RESULTBhatt 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.
PMID: 31707829RESULTOlshansky 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.
PMID: 33010162RESULTPeterson 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.
PMID: 33148016RESULTBhatt 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.
PMID: 31439224RESULTGaba 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.
PMID: 34620410RESULTMajithia 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.
PMID: 34706555RESULTVerma 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.
PMID: 34710343RESULTSingh 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.
PMID: 35027114RESULTGurevitz C, Bhatt DL, Giugliano RP, Steg PG, Miller M, Brinton EA, Jacobson TA, Ketchum SB, Lira Pineda A, Doyle RT Jr, Giugliano G, Mason RP, Tardif JC, Martens FMAC, Ballantyne CM, Budoff MJ, Gibson CM. Benefit of Icosapent Ethyl Across Types and Sizes of Myocardial Infarction in REDUCE-IT. Eur J Prev Cardiol. 2025 Sep 22:zwaf602. doi: 10.1093/eurjpc/zwaf602. Online ahead of print.
PMID: 40982548DERIVEDAggarwal R, Bhatt DL, Steg PG, Miller M, Brinton EA, Dunbar RL, Ketchum SB, Tardif JC, Martens FMAC, Ballantyne CM, Szarek M, Mason RP; REDUCE-IT Investigators. Cardiovascular Outcomes With Icosapent Ethyl by Baseline Low-Density Lipoprotein Cholesterol: A Secondary Analysis of the REDUCE-IT Randomized Trial. J Am Heart Assoc. 2025 Mar 4;14(5):e038656. doi: 10.1161/JAHA.124.038656. Epub 2025 Feb 19.
PMID: 39968782DERIVEDWeintraub WS, Bhatt DL, Zhang Z, Dolman S, Boden WE, Bress AP, Bellows BK, Derington CG, Philip S, Steg G, Miller M, Brinton EA, Jacobson TA, Tardif JC, Ballantyne CM, Kolm P. Cost-Effectiveness of Icosapent Ethyl in REDUCE-IT USA: Results From Patients Randomized in the United States. J Am Heart Assoc. 2024 Jan 2;13(1):e032413. doi: 10.1161/JAHA.123.032413. Epub 2023 Dec 29.
PMID: 38156550DERIVEDMiller M, Bhatt DL, Brinton EA, Jacobson TA, Steg PG, Pineda AL, Ketchum SB, Doyle RT Jr, Tardif JC, Ballantyne CM. Effectiveness of icosapent ethyl on first and total cardiovascular events in patients with metabolic syndrome, but without diabetes: REDUCE-IT MetSyn. Eur Heart J Open. 2023 Nov 12;3(6):oead114. doi: 10.1093/ehjopen/oead114. eCollection 2023 Nov.
PMID: 38035037DERIVEDOlshansky B, Bhatt DL, Miller M, Steg PG, Brinton EA, Jacobson TA, Ketchum SB, Doyle RT Jr, Juliano RA, Jiao L, Kowey PR, Reiffel JA, Tardif JC, Ballantyne CM, Chung MK; REDUCE-IT Investigators. Cardiovascular Benefits of Icosapent Ethyl in Patients With and Without Atrial Fibrillation in REDUCE-IT. J Am Heart Assoc. 2023 Mar 7;12(5):e026756. doi: 10.1161/JAHA.121.026756. Epub 2023 Feb 21.
PMID: 36802845DERIVEDRidker 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.
PMID: 35762321DERIVEDGaba 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.
PMID: 35483753DERIVEDSelvaraj 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.
PMID: 35377160DERIVEDPeterson 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.
PMID: 35261279DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Alexander Giaquinto, Executive Director, Regulatory Affairs
- Organization
- Amarin Pharma, Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Deepak L. Bhatt, MD, MPH
Brigham and Women's Hospital, 75 Francis Street, Boston
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 13, 2011
First Posted
December 15, 2011
Study Start
November 1, 2011
Primary Completion
May 1, 2018
Study Completion
May 1, 2018
Last Updated
April 14, 2022
Results First Posted
April 14, 2022
Record last verified: 2022-03
Data Sharing
- IPD Sharing
- Will not share