Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
NCT ID: NCT02104817
Last Updated: 2021-08-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
13078 participants
INTERVENTIONAL
2014-10-30
2020-05-27
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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EPANOVA
Epanova + statin, once daily
Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
Corn oil
Corn oil + Statin
corn oil control
corn oil control arm
Interventions
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Epanova® (omega-3 carboxylic acids)
Adjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)
corn oil control
corn oil control arm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Patient must be on a stable diet and statin\* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
1. LDL-C \<100 mg/dL
2. TG level ≥180 and \<500 mg/dL and HDL-C \<42 mg/dL for men or HDL-C \<47 mg/dL for women
3. Patient is at high risk for a future cardiovascular event if at least one of the following criteria (3a, 3b or 3c)\* is present via patient history, physical exam, or medical records at the time of screening:
1. Any atherosclerotic CVD as defined in protocol.
2. History of diabetes mellitus (type 1 or 2) and ≥40 years of age for men and ≥50 years of age for women, plus one of the risk factors defined in protocol.
3. Male patients \>50 years of age or females \>60 years of age, with at least one of the risk factors defined in protocol.
Exclusion Criteria
18 Years
99 Years
ALL
No
Sponsors
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The Cleveland Clinic
OTHER
IQVIA RDS Inc.
INDUSTRY
AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Steven Nissen, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Michael Lincoff, MD
Role: PRINCIPAL_INVESTIGATOR
The Cleveland Clinic
Stephen Nicholls, MD
Role: PRINCIPAL_INVESTIGATOR
MonashHeart
Locations
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Birmingham, Alabama, United States
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Huntsville, Alabama, United States
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Muscle Shoals, Alabama, United States
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Chandler, Arizona, United States
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Gilbert, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Tempe, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Little Rock, Arkansas, United States
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Carlsbad, California, United States
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Fresno, California, United States
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Fresno, California, United States
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Greenbrae, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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Milpitas, California, United States
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Newport Beach, California, United States
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Northridge, California, United States
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Palm Springs, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Santa Rosa, California, United States
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Tarzana, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Denver, Colorado, United States
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Waterbury, Connecticut, United States
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Boca Raton, Florida, United States
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Clearwater, Florida, United States
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Coral Gables, Florida, United States
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Davie, Florida, United States
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Delray Beach, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Jacksonville, Florida, United States
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Jacksonville, Florida, United States
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Lake Worth, Florida, United States
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Lakeland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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New Port Richey, Florida, United States
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Pembroke Pines, Florida, United States
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Pensacola, Florida, United States
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Pinellas Park, Florida, United States
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Port Charlotte, Florida, United States
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Spring Hill, Florida, United States
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Tamarac, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Sandy Springs, Georgia, United States
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Savannah, Georgia, United States
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Arlington Heights, Illinois, United States
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Blue Island, Illinois, United States
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Champaign, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Naperville, Illinois, United States
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Oakbrook Terrace, Illinois, United States
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Sterling, Illinois, United States
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Anderson, Indiana, United States
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Elkhart, Indiana, United States
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Evansville, Indiana, United States
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Fort Wayne, Indiana, United States
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Franklin, Indiana, United States
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Muncie, Indiana, United States
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Valparaiso, Indiana, United States
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Iowa City, Iowa, United States
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Augusta, Kansas, United States
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Louisville, Kentucky, United States
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Monroe, Louisiana, United States
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Shreveport, Louisiana, United States
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Slidell, Louisiana, United States
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Auburn, Maine, United States
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Elkridge, Maryland, United States
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Hyannis, Massachusetts, United States
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Quincy, Massachusetts, United States
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Bay City, Michigan, United States
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Cadillac, Michigan, United States
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Kalamazoo, Michigan, United States
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Edina, Minnesota, United States
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Minneapolis, Minnesota, United States
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Port Gibson, Mississippi, United States
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Haddon Heights, New Jersey, United States
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Saratoga Springs, New York, United States
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Southampton, New York, United States
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Troy, New York, United States
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Asheville, North Carolina, United States
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Norman, Oklahoma, United States
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Bend, Oregon, United States
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Allentown, Pennsylvania, United States
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Beaver, Pennsylvania, United States
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Doylestown, Pennsylvania, United States
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Ephrata, Pennsylvania, United States
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Burke, Virginia, United States
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Lynchburg, Virginia, United States
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Manassas, Virginia, United States
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Port Orchard, Washington, United States
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Mol, , Belgium
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Mons, , Belgium
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New Westminster, British Columbia, Canada
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Vancouver, British Columbia, Canada
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Barrie, Ontario, Canada
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Cambridge, Ontario, Canada
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Etobicoke, Ontario, Canada
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Lanzhou, , China
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Nanjing, , China
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Shenyang, , China
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Xi'an, , China
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Beroun, , Czechia
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Hradec Králové, , Czechia
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Jindřichův Hradec, , Czechia
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Olomouc, , Czechia
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Ostrava, , Czechia
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Pardubice, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Prague, , Czechia
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Praha 10 - Strasnice, , Czechia
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Přerov, , Czechia
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Slaný, , Czechia
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Trutnov, , Czechia
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Třemošná, , Czechia
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Zlín, , Czechia
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Aalborg, , Denmark
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Århus N, , Denmark
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Hellerup, , Denmark
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Herlev, , Denmark
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København Ø, , Denmark
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Svendborg, , Denmark
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Haabneeme, , Estonia
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Pärnu, , Estonia
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Baja, , Hungary
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Budapest, , Hungary
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Csorna, , Hungary
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Debrecen, , Hungary
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Panevezys, , Lithuania
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Chihuahua City, , Mexico
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Mérida, , Mexico
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Almelo, , Netherlands
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Sopot, , Poland
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Staszów, , Poland
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Torun, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Wroclaw, , Poland
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Zamość, , Poland
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Zgierz, , Poland
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Barnaul, , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Kemerovo, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Novosibirsk, , Russia
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Omsk, , Russia
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Orenburg, , Russia
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Perm, , Russia
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Rostov-on-Don, , Russia
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Ryazan, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Tomsk, , Russia
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Tomsk, , Russia
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Yaroslavl, , Russia
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Yaroslavl, , Russia
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Bloemfontein, , South Africa
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Breyten, , South Africa
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Brits, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Cape Town, , South Africa
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Centurion, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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Durban, , South Africa
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George, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Johannesburg, , South Africa
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Krugersdorp, , South Africa
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Kuilsrivier, , South Africa
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KwaDukuza, , South Africa
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Mamelodi East, , South Africa
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Middelburg, , South Africa
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Moloto South, , South Africa
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Paarl, , South Africa
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Port Elizabeth, , South Africa
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Port Elizabeth, , South Africa
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Port Elizabeth, , South Africa
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Potchefstroom, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Pretoria, , South Africa
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Somerset West, , South Africa
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Soweto, , South Africa
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Verulam, , South Africa
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Worcester, , South Africa
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Busan, , South Korea
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Busan, , South Korea
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Gwangju, , South Korea
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Incheon, , South Korea
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Seongnam-si, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Seoul, , South Korea
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Ulsan, , South Korea
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Kaohsiung City, , Taiwan
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Kaohsiung City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Cherkasy, , Ukraine
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Ivano-Frankivsk, , Ukraine
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Kharkiv Region, , Ukraine
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Kharkiv Region, , Ukraine
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Kharkiv Region, , Ukraine
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Kharkiv Region, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Kyiv, , Ukraine
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Lutsk, , Ukraine
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Lviv, , Ukraine
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Lviv, , Ukraine
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Mykolaiv, , Ukraine
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Odesa, , Ukraine
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Poltava, , Ukraine
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Uzhhorod, , Ukraine
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Uzhhorod, , Ukraine
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Vinnytsia, , Ukraine
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Vinnytsia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zaporizhzhia, , Ukraine
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Zhytomyr, , Ukraine
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Airdrie, , United Kingdom
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Bournemouth, , United Kingdom
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Cardiff, , United Kingdom
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Chelmsford, , United Kingdom
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Chorley, , United Kingdom
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East Kilbride, , United Kingdom
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Edgbaston, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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Hexham, , United Kingdom
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Leicester, , United Kingdom
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Liverpool, , United Kingdom
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Liverpool, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Reading, , United Kingdom
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Romford, , United Kingdom
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Stevenage, , United Kingdom
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Swansea, , United Kingdom
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Torquay, , United Kingdom
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References
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Nissen SE, Lincoff AM, Wolski K, Ballantyne CM, Kastelein JJP, Ridker PM, Ray KK, McGuire DK, Mozaffarian D, Koenig W, Davidson MH, Garcia M, Katona BG, Himmelmann A, Loss LE, Poole M, Menon V, Nicholls SJ. Association Between Achieved omega-3 Fatty Acid Levels and Major Adverse Cardiovascular Outcomes in Patients With High Cardiovascular Risk: A Secondary Analysis of the STRENGTH Trial. JAMA Cardiol. 2021 Aug 1;6(8):910-917. doi: 10.1001/jamacardio.2021.1157.
Nicholls SJ, Lincoff AM, Garcia M, Bash D, Ballantyne CM, Barter PJ, Davidson MH, Kastelein JJP, Koenig W, McGuire DK, Mozaffarian D, Ridker PM, Ray KK, Katona BG, Himmelmann A, Loss LE, Rensfeldt M, Lundstrom T, Agrawal R, Menon V, Wolski K, Nissen SE. Effect of High-Dose Omega-3 Fatty Acids vs Corn Oil on Major Adverse Cardiovascular Events in Patients at High Cardiovascular Risk: The STRENGTH Randomized Clinical Trial. JAMA. 2020 Dec 8;324(22):2268-2280. doi: 10.1001/jama.2020.22258.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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2014-001069-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D5881C00004
Identifier Type: -
Identifier Source: org_study_id
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