Cardiovascular Diseases Clinical Trial
— REDUCE-ITOfficial 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)
| Verified date | March 2022 |
| Source | Amarin Pharma Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Amarin Pharma Inc. |
United States, Australia, Canada, India, Netherlands, New Zealand, Poland, Romania, Russian Federation, South Africa, Ukraine,
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
| 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. |
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