Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)Phase 3STRENGTHNCT02104817

Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia

A Phase 3 study testing Epanova® (omega-3 carboxylic acids) in people with Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD), run by AstraZeneca at 684 sites in 22 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The study is a randomized, double-blind, placebo-controlled (corn oil), parallel group design that will enroll approximately 13,000 patients with hypertriglyceridemia and low HDL and high risk for CVD to be randomized 1:1 to either corn oil + statin or Epanova + statin, once daily, for approximately 3-5 years as… Read more about this study

Who is it for?: Ages 18 to 99 years
Conditions the study is for: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
What is being tested?: Epanova® (omega-3 carboxylic acids)
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 13,078 participants
Where: 684 sitesin 22 countries
Study dates: 30 Oct 2014to 27 May 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 99 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Men or women, ≥18 years of age.
Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
LDL-C <100 mg/dL
TG level ≥180 and <500 mg/dL and HDL-C <42 mg/dL for men or HDL-C <47 mg/dL for women
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:
Any atherosclerotic CVD as defined in protocol.
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.
Male patients >50 years of age or females >60 years of age, with at least one of the risk factors defined in protocol.

Who cannot join

1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.

Trial locations and contacts

684 sites in 22 countries.

Country

City, postcode or hospital

684 sites in 22 countries

United States229 sites

Research Site
Akron, Ohio, 44311
Research Site
Albany, New York, 12205
Research Site
Albany, New York, 12208
Research Site
Albany, New York, 12211
Research Site
Allentown, Pennsylvania, 18103
Research Site
Anderson, Indiana, 46011
Research Site
Anderson, South Carolina, 29621
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Arlington, Texas, 76012
Research Site
Arlington Heights, Illinois, 60005
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Asheville, North Carolina, 28801
Research Site
Atlanta, Georgia, 30308
Research Site
Auburn, Maine, 04210
Research Site
Augusta, Kansas, 67010
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Austin, Texas, 78758
Research Site
Avon, Indiana, 46123
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Baltimore, Maryland, 21228
Research Site
Baltimore, Maryland, 21229
Research Site
Bay City, Michigan, 48708
Research Site
Beaver, Pennsylvania, 15009
Research Site
Bend, Oregon, 97701
Research Site
Binghamton, New York, 13901
Research Site
Birmingham, Alabama, 35205
Research Site
Birmingham, Alabama, 35211
Research Site
Birmingham, Alabama, 35233
Research Site
Birmingham, Alabama, 35235
Research Site
Blue Island, Illinois, 60406
Research Site
Boca Raton, Florida, 33431
Research Site
Bridgeton, Missouri, 63044
Research Site
Bridgewater, New Jersey, 08807
Research Site
Bristol, Tennessee, 37620
Research Site
Burke, Virginia, 22015
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Cadillac, Michigan, 49601
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Camden, New Jersey, 08103
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Carlsbad, California, 92008
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Cary, North Carolina, 27518
Research Site
Champaign, Illinois, 61820
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Chandler, Arizona, 85224
Research Site
Charleston, South Carolina, 29407
Research Site
Charleston, South Carolina, 29425
Research Site
Charlotte, North Carolina, 28204
Research Site
Charlotte, North Carolina, 28207
Research Site
Charlotte, North Carolina, 28209
Research Site
Charlotte, North Carolina, 28277
Research Site
Chattanooga, Tennessee, 37421
Research Site
Chicago, Illinois, 60637
Research Site
Chicago, Illinois, 60654
Research Site
Cincinnati, Ohio, 45219
Research Site
Cincinnati, Ohio, 45227
Research Site
Cincinnati, Ohio, 45236
Research Site
Cincinnati, Ohio, 45246
Research Site
Clearwater, Florida, 33756
Research Site
Cleveland, Ohio, 44195
Research Site
Clinton, Utah, 84015
Research Site
Colorado Springs, Colorado, 80909
Research Site
Columbus, Ohio, 43210
Research Site
Coral Gables, Florida, 33134
Research Site
Corpus Christi, Texas, 78413
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Corvallis, Oregon, 97330
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Dallas, Texas, 75390
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Danville, Pennsylvania, 17822
Research Site
Danville, Virginia, 24541
Research Site
Davie, Florida, 33330
Research Site
Delray Beach, Florida, 33446
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Denver, Colorado, 80239-3133
Research Site
Denver, Colorado, 80239
Research Site
Denver, Colorado, 80246
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Doylestown, Pennsylvania, 18901
Research Site
Edina, Minnesota, 55435
Research Site
Elkhart, Indiana, 46514
Research Site
Elkridge, Maryland, 21075
Research Site
Elmer, New Jersey, 08318
Research Site
Ephrata, Pennsylvania, 17522
Research Site
Evanston, Illinois, 60201
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Evansville, Indiana, 47714
Research Site
Evansville, Indiana, 47715
Research Site
Flourtown, Pennsylvania, 19031
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Fort Lauderdale, Florida, 33308
Research Site
Fort Wayne, Indiana, 46845
Research Site
Fort Worth, Texas, 76107
Research Site
Fort Worth, Texas, 76117
Research Site
Fort Worth, Texas, 76132
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Fountain Inn, South Carolina, 29681
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Franklin, Indiana, 46131
Research Site
Fresno, California, 93720
Research Site
Fresno, California, 93721
Research Site
Gilbert, Arizona, 85295
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Glendale, Arizona, 85308
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Grand Forks, North Dakota, 58201
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Green Bay, Wisconsin, 54301
Research Site
Greenbrae, California, 94904
Research Site
Greenfield, Indiana, 46140
Research Site
Greensboro, North Carolina, 27408
Research Site
Greenville, North Carolina, 27834
Research Site
Greer, South Carolina, 29650
Research Site
Greer, South Carolina, 29651
Research Site
Haddon Heights, New Jersey, 08035
Research Site
Hazelwood, Missouri, 63042
Research Site
Herndon, Virginia, 20171
Research Site
Hialeah, Florida, 33012
Research Site
Hickory, North Carolina, 28602
Research Site
Homestead, Florida, 33130
Research Site
Houston, Texas, 77030
Research Site
Houston, Texas, 77070
Research Site
Houston, Texas, 77079
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Huntsville, Alabama, 35801
Research Site
Hyannis, Massachusetts, 02601
Research Site
Iowa City, Iowa, 52242
Research Site
Irving, Texas, 75061
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Jacksonville, Florida, 32216
Research Site
Jacksonville, Florida, 32277
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Johnson City, Tennessee, 37604
Research Site
Johnstown, Pennsylvania, 15905
Research Site
Kalamazoo, Michigan, 49048
Research Site
Kingsport, Tennessee, 37660
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Knoxville, Tennessee, 37912
Research Site
Knoxville, Tennessee, 37934
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La Crosse, Wisconsin, 54601
Research Site
Lake Worth, Florida, 33461
Research Site
Lakeland, Florida, 33805
Research Site
Las Vegas, Nevada, 89120
Research Site
Laurelton, New York, 11413
Research Site
Lawrence, New York, 11559
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Little Rock, Arkansas, 72205
Research Site
Little Rock, Arkansas, 72211
Research Site
Long Beach, California, 90807
Research Site
Los Angeles, California, 90069
Research Site
Louisville, Kentucky, 40213
Research Site
Lynchburg, Virginia, 24501
Research Site
Madison, Wisconsin, 53715
Research Site
Manassas, Virginia, 20109
Research Site
Manassas, Virginia, 20110
Research Site
Marietta, Georgia, 30067
Research Site
Marion, Ohio, 43302
Research Site
Maumee, Ohio, 43537
Research Site
Mesa, Arizona, 85206
Research Site
Mesa, Arizona, 85213
Research Site
Miami, Florida, 33142
Research Site
Miami, Florida, 33173
Research Site
Miami, Florida, 33176
Research Site
Middleburg Hts, Ohio, 44130
Research Site
Midwest City, Oklahoma, 73110
Research Site
Milpitas, California, 95035
Research Site
Minneapolis, Minnesota, 55455
Research Site
Mission, Texas, 78572
Research Site
Monroe, Louisiana, 71203
Research Site
Mooresville, North Carolina, 28117
Research Site
Morganton, North Carolina, 28655
Research Site
Mt. Pleasant, South Carolina, 29464
Research Site
Muncie, Indiana, 47304
Research Site
Muscle Shoals, Alabama, 35662
Research Site
Naperville, Illinois, 60566-7226
Research Site
Natrona Heights, Pennsylvania, 15065
Research Site
New Port Richey, Florida, 34652
Research Site
New York, New York, 10029
Research Site
Newport, Pennsylvania, 17011
Research Site
Newport Beach, California, 92663
Research Site
Norman, Oklahoma, 73069
Research Site
Northridge, California, 91325-4139
Research Site
Oakbrook Terrace, Illinois, 60181
Research Site
Odessa, Texas, 79761
Research Site
Ogden, Utah, 84405
Research Site
Oklahoma City, Oklahoma, 73112-4703
Research Site
Oklahoma City, Oklahoma, 73135
Research Site
Omaha, Nebraska, 68114-1119
Research Site
Omaha, Nebraska, 68114
Research Site
Omaha, Nebraska, 68131
Research Site
Omaha, Nebraska, 68144
Research Site
Orem, Utah, 84058
Research Site
Overland Park, Kansas, 66210
Research Site
Palm Springs, California, 92262
Research Site
Pembroke Pines, Florida, 33026
Research Site
Pembroke Pines, Florida, 33027
Research Site
Pensacola, Florida, 32501
Research Site
Philadelphia, Pennsylvania, 19104
Research Site
Phoenix, Arizona, 85032
Research Site
Pinellas Park, Florida, 33781
Research Site
Plano, Texas, 75093
Research Site
Port Charlotte, Florida, 33952
Research Site
Port Gibson, Mississippi, 39150
Research Site
Port Matilda, Pennsylvania, 16870-7153
Research Site
Port Orchard, Washington, 98366
Research Site
Portland, Oregon, 97229
Research Site
Portland, Oregon, 97239
Research Site
Quincy, Massachusetts, 02169
Research Site
Raleigh, North Carolina, 27607
Research Site
Rapid City, South Dakota, 57701
Research Site
Rock Hill, South Carolina, 29732
Research Site
Rocky Mount, North Carolina, 27804
Research Site
Saginaw, Michigan, 48601
Research Site
Saginaw, Michigan, 48602
Research Site
Salisbury, North Carolina, 28144
Research Site
Salt Lake City, Utah, 84102
Research Site
Salt Lake City, Utah, 84107
Research Site
Salt Lake City, Utah, 84124
Research Site
San Antonio, Texas, 78212
Research Site
San Antonio, Texas, 78217
Research Site
San Antonio, Texas, 78228
Research Site
San Diego, California, 92103-6204
Research Site
Sandy Springs, Georgia, 30328
Research Site
Santa Ana, California, 92705
Research Site
Santa Rosa, California, 95405
Research Site
Saratoga Springs, New York, 12866
Research Site
Savannah, Georgia, 31405
Research Site
Sewell, New Jersey, 08080
Research Site
Shreveport, Louisiana, 71101
Research Site
Sicklerville, New Jersey, 08081
Research Site
Simpsonville, South Carolina, 29681
Research Site
Slidell, Louisiana, 70458
Research Site
Southampton, New York, 11968
Research Site
Spartanburg, South Carolina, 29302
Research Site
Spring Hill, Florida, 34609
Research Site
Sterling, Illinois, 61081
Research Site
Tamarac, Florida, 33321
Research Site
Tarzana, California, 91356
Research Site
Tempe, Arizona, 85283
Research Site
Tipton, Pennsylvania, 16684
Research Site
Traverse City, Michigan, 49684
Research Site
Troy, New York, 12180
Research Site
Tucson, Arizona, 85710
Research Site
Tucson, Arizona, 85712
Research Site
Tucson, Arizona, 85741
Research Site
Tupelo, Mississippi, 38801
Research Site
Valparaiso, Indiana, 46383
Research Site
Victoria, Texas, 77901
Research Site
Waterbury, Connecticut, 06708
Research Site
Wausau, Wisconsin, 54401
Research Site
Wilkes-Barre, Pennsylvania, 18711
Research Site
Wilmington, North Carolina, 28401
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

Japan50 sites

Research Site
Adachi-ku, 120-0006
Research Site
Adachi-ku, 120-0022
Research Site
Akishima-shi, 196-0003
Research Site
Akita, 010-1423
Research Site
Amagasaki-shi, 660-0807
Research Site
Chikushi-gun, 811-1244
Research Site
Chikushino-shi, 818-8516
Research Site
Chūōku, 103-0027
Research Site
Chūōku, 104-0031
Research Site
Fujisawa-shi, 251-8550
Research Site
Gifu, 500-8384
Research Site
Hachioji-shi, 192-0918
Research Site
Hachioji-shi, 193-0811
Research Site
Hakusan-shi, 924-8588
Research Site
Ichikawa-shi, 272-8516
Research Site
Imabari, 794-0006
Research Site
Itoshima-shi, 819-1104
Research Site
Kasugai-shi, 487-0031
Research Site
Kawanishi-shi, 666-0125
Research Site
Kishiwada-shi, 596-8522
Research Site
Kitakyushu-shi, 802-0001
Research Site
Kochi, 780-8522
Research Site
Kyoto, 607-8062
Research Site
Maebashi, 371-0004
Research Site
Matsudo-shi, 270-2251
Research Site
Matsumoto-shi, 390-1401
Research Site
Matsuyama, 790-0067
Research Site
Meguro-ku, 153-0051
Research Site
Minatoku, 108-0075
Research Site
Nagoya, 462-0825
Research Site
Nakagami-gun, 901-2393
Research Site
Niigata, 956-0025
Research Site
Ōita, 870-0192
Research Site
Onga-gun, 807-0051
Research Site
Osaka, 530-0001
Research Site
Osaka, 532-0003
Research Site
Saga, 849-0917
Research Site
Sapporo, 003-0026
Research Site
Sapporo, 006-0811
Research Site
Sapporo, 060-0031
Research Site
Sendai, 980-0803
Research Site
Shinagawa-ku, 141-0032
Research Site
Shinjuku-ku, 169-0073
Research Site
Takamatsu, 760-8538
Research Site
Takasaki-shi, 370-0036
Research Site
Tokorozawa-shi, 359-1141
Research Site
Toshima-ku, 171-0014
Research Site
Tsuchiura-shi, 300-0028
Research Site
Yokohama, 231-8682
Research Site
Yokohama, 236-0004

Other trials in Japan

South Africa41 sites

Research Site
Bloemfontein, 9301
Research Site
Breyten, 2330
Research Site
Brits, 0250
Research Site
Cape Town, 1730
Research Site
Cape Town, 7505
Research Site
Cape Town, 7764
Research Site
Cape Town, 7925
Research Site
Centurion, 1692
Research Site
Durban, 4001
Research Site
Durban, 4068
Research Site
Durban, 4096
Research Site
Durban, 4120
Research Site
George, 6529
Research Site
Johannesburg, 1449
Research Site
Johannesburg, 1724
Research Site
Johannesburg, 1818
Research Site
Johannesburg, 2113
Research Site
Johannesburg, 2188
Research Site
Krugersdorp, 1739
Research Site
Kuilsrivier, 7580
Research Site
KwaDukuza, 4450
Research Site
Mamelodi East, 0184
Research Site
Middelburg, 1055
Research Site
Moloto South, 1022
Research Site
Paarl, 7646
Research Site
Port Elizabeth, 6001
Research Site
Port Elizabeth, 6014
Research Site
Port Elizabeth, 6057
Research Site
Potchefstroom, 2531
Research Site
Pretoria, 0002
Research Site
Pretoria, 0084
Research Site
Pretoria, 0101
Research Site
Pretoria, 0158
Research Site
Pretoria, 0181
Research Site
Pretoria, 0183
Research Site
Pretoria, 0184
Research Site
Pretoria, 0186
Research Site
Somerset West, 7130
Research Site
Soweto, 2013
Research Site
Verulam, 4339
Research Site
Worcester, 6850

Other trials in South Africa

China38 sites

Research Site
Beijing, 100035
Research Site
Beijing, 100044
Research Site
Beijing, 100070
Research Site
Changchun, 130021
Research Site
Changchun, 130033
Research Site
Changsha, 410011
Research Site
Changsha, 410013
Research Site
Chengdu, 610041
Research Site
Chongqing, 400010
Research Site
Guangzhou, 510080
Research Site
Guangzhou, 510100
Research Site
Guangzhou, 510515
Research Site
Guangzhou, 510630
Research Site
Haerbin, 150001
Research Site
Haikou, 570102
Research Site
Hohhot, 010017
Research Site
Jilin City, 132000
Research Site
Lanzhou, 730030
Research Site
Nanchang, 330006
Research Site
Nanjing, 210011
Research Site
Nanning, 530021
Research Site
Shanghai, 200025
Research Site
Shanghai, 200062
Research Site
Shanghai, 200065
Research Site
Shanghai, 200090
Research Site
Shenyang, 110001
Research Site
Suzhou, 215028
Research Site
Taiyuan, 030001
Research Site
Tianjin, 300052
Research Site
Tianjin, 300457
Research Site
Ürümqi, 830054
Research Site
Xi'an, 710061
Research Site
Xuzhou, 221006
Research Site
Yanji, 133000
Research Site
Yinchuan, 750004
Research Site
Yueyang, 414000
Research Site
Zhanjiang, 524001
Research Site
Zhenjiang, 212002

Other trials in China

Hungary35 sites

Research Site
Baja, 6500
Research Site
Balatonfüred, 8230
Research Site
Balatongyörök, 8313
Research Site
Ballasagyarmat, 2660
Research Site
Békéscsaba, 5600
Research Site
Budapest, 1033
Research Site
Budapest, 1036
Research Site
Budapest, 1083
Research Site
Budapest, 1122
Research Site
Budapest, 1125
Research Site
Budapest, 1134
Research Site
Budapest, 1135
Research Site
Csorna, 9300
Research Site
Debrecen, 4025
Research Site
Debrecen, 4032
Research Site
Eger, 3300
Research Site
Gödöllő, 2100
Research Site
Gyula, 5700
Research Site
Hajdúszoboszló, 4200
Research Site
Hatvan, 3000
Research Site
Kalocsa, 6300
Research Site
Kiskunhalas, 6400
Research Site
Komárom, 2921
Research Site
Létavértes, 4281
Research Site
Mohács, 7700
Research Site
Nagykanizsa, 8800
Research Site
Nyíregyháza, 4400
Research Site
Nyíregyháza, 4405
Research Site
Szeged, 6720
Research Site
Szeged, 6722
Research Site
Székesfehérvár, 8000
Research Site
Szekszárd, 7100
Research Site
Szentes, 6600
Research Site
Veszprém, 8200
Research Site
Zalaegerszeg, 8900

Other trials in Hungary

Poland33 sites

Research Site
Bialystok, 15-879
Research Site
Chorzów, 41-500
Research Site
Elblag, 82-300
Research Site
Gdansk, 80-286
Research Site
Gdansk, 80-382
Research Site
Gdansk, 80-952
Research Site
Gdynia, 81-157
Research Site
Gdynia, 81-384
Research Site
Katowice, 40-040
Research Site
Krakow, 31-216
Research Site
Krakow, 31-501
Research Site
Lodz, 91-490
Research Site
Lodz, 94-050
Research Site
Lodz, 94-255
Research Site
Lublin, 20-362
Research Site
Lublin, 20-538
Research Site
Oświęcim, 32-600
Research Site
Parczew, 21-200
Research Site
Piaseczno, 05-500
Research Site
Poznan, 60-702
Research Site
Poznan, 61-655
Research Site
Puławy, 24-100
Research Site
Ruda Śląska, 41-709
Research Site
Rzeszów, 35-055
Research Site
Sobótka, 05-050
Research Site
Sopot, 81-717
Research Site
Staszów, 28-200
Research Site
Torun, 87-100
Research Site
Warsaw, 01-192
Research Site
Wroclaw, 50-088
Research Site
Wroclaw, 50-305
Research Site
Zamość, 22-400
Research Site
Zgierz, 95-100

Other trials in Poland

Russia30 sites

Research Site
Barnaul, 656055
Research Site
Kemerovo, 650000
Research Site
Kemerovo, 650002
Research Site
Kemerovo, 650066
Research Site
Moscow, 107014
Research Site
Moscow, 117556
Research Site
Moscow, 121374
Research Site
Moscow, 125367
Research Site
Moscow, 127473
Research Site
Moscow, 129301
Research Site
Novosibirsk, 630008
Research Site
Novosibirsk, 630047
Research Site
Novosibirsk, 630054
Research Site
Novosibirsk, 630089
Research Site
Omsk, 644018
Research Site
Orenburg, 460040
Research Site
Perm, 6144090
Research Site
Rostov-on-Don, 344068
Research Site
Ryazan, 390026
Research Site
Saint Petersburg, 194044
Research Site
Saint Petersburg, 194291
Research Site
Saint Petersburg, 196247
Research Site
Saint Petersburg, 197022
Research Site
Saint Petersburg, 197341
Research Site
Saint Petersburg, 198035
Research Site
Saint Petersburg, 199106
Research Site
Tomsk, 634012
Research Site
Tomsk, 634034
Research Site
Yaroslavl, 150003
Research Site
Yaroslavl, 150047

Other trials in Russia

Ukraine30 sites

Research Site
Cherkasy, 18009
Research Site
Ivano-Frankivsk, 76005
Research Site
Kharkiv Region, 61039
Research Site
Kharkiv Region, 61103
Research Site
Kharkiv Region, 61157
Research Site
Kharkiv Region, 61176
Research Site
Kyiv, 01103
Research Site
Kyiv, 01601
Research Site
Kyiv, 02002
Research Site
Kyiv, 02091
Research Site
Kyiv, 02232
Research Site
Kyiv, 02660
Research Site
Kyiv, 03037
Research Site
Kyiv, 03049
Research Site
Kyiv, 03115
Research Site
Kyiv, 03680
Research Site
Kyiv, 04114
Research Site
Lutsk, 43024
Research Site
Lviv, 79034
Research Site
Lviv, 79059
Research Site
Mykolaiv, 54003
Research Site
Odesa, 65114
Research Site
Poltava, 36011
Research Site
Uzhhorod, 88009
Research Site
Uzhhorod, 88014
Research Site
Vinnytsia, 21018
Research Site
Vinnytsia, 21029
Research Site
Zaporizhzhya, 69001
Research Site
Zaporizhzhya, 69096
Research Site
Zhytomyr, 10002

Other trials in Ukraine

Netherlands29 sites

Research Site
Almelo, 7600SZ
Research Site
Almere Stad, 1311 RL
Research Site
Amsterdam, 1061 AE
Research Site
Amsterdam, 1105 AZ
Research Site
Apeldoorn, 7334 DZ
Research Site
Arnhem, 6815 AD
Research Site
Beek, 6191 JW
Research Site
Delft, 2625 AD
Research Site
Ede, 6716 RP
Research Site
Eindhoven, 5611 NV
Research Site
Eindhoven, 5623EJ
Research Site
Harderwijk, 3844 DG
Research Site
Heerlen, 6419 PC
Research Site
Hilversum, 1213 XZ
Research Site
Hoofddorp, 2134 TM
Research Site
Hoogeveen, 7909 AA
Research Site
Hoorn, 1625 HV
Research Site
Maastricht, 6229 HX
Research Site
Nijmegen, 6525 EC
Research Site
Rotterdam, 3021 HC
Research Site
Rotterdam, 3045 PM
Research Site
Schiedam, 3118 JH
Research Site
Sneek, 8601 ZK
Research Site
Tilburg, 5042AD
Research Site
Utrecht, 3511 NH
Research Site
Utrecht, 3584 CX
Research Site
Venlo, 5912 BL
Research Site
Zoetermeer, 2725 NA
Research Site
Zwijndrecht, 3331 LZ

Other trials in Netherlands

Czechia23 sites

Research Site
Beroun, 266 01
Research Site
Brno, 615 00
Research Site
Brno, 656 91
Research Site
Choceň, 565 01
Research Site
Chrudim, 537 02
Research Site
Hodonín, 695 01
Research Site
Hostivice, 253 01
Research Site
Hradec Králové, 500 02
Research Site
Hradec Králové, 500 05
Research Site
Jindřichův Hradec, 377 01
Research Site
Olomouc, 77900
Research Site
Ostrava, 702 00
Research Site
Pardubice, 530 02
Research Site
Prague, 140 59
Research Site
Prague, 150 06
Research Site
Prague, 158 00
Research Site
Prague, 181 00
Research Site
Praha 10 - Strasnice, 100 00
Research Site
Přerov, 750 00
Research Site
Slaný, 274 01
Research Site
Třemošná, 33011
Research Site
Trutnov, 541 01
Research Site
Zlín, 762 75

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About this study

Official title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)

Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Being tested: Epanova® (omega-3 carboxylic acids), corn oil control
Keywords: omega-3 carboxylic acid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Epanova® (omega-3 carboxylic acids)Drug
Also called 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 controlDrug
corn oil control arm

Study groups in NCT02104817
Study group	Role	What they receive
EPANOVA	Experimental	Epanova + statin, once daily Receives: Drug: Epanova® (omega-3 carboxylic acids)
Corn oil	Active comparator	Corn oil + Statin Receives: Drug: corn oil control

What is being measured

The primary outcome is the main question the study is designed to answer.

The Composite of Major Adverse Cardiovascular Events (MACE)
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Secondary outcomes (9)

The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events
CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
CV events include: cardiovascular (CV) death, non-fatal myocardial infarction (MI) and non-fatal stroke. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events
Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
Coronary events include: cardiac death (including death due to acute myocardial infarction, sudden cardiac death and death due to cardiovascular procedures), non-fatal myocardial infarction (MI), emergent/elective coronary revascularization and hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) in the subgroup of participants with established CVD at baseline
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
CV Death
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death.
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
CV Death in the Subgroup of Participants With Established CVD at Baseline
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed), last date known to be alive, and date of non-cardiovascular death in the subgroup of participants with established CVD at baseline
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
All-cause Death
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive.
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
All-cause Death in the Subgroup of Participants With Established CVD at Baseline
Participants with no observed events are censored at the latest of the date of last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed) and last date known to be alive in the subgroup of participants with established CVD at baseline
Measured: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

30 Oct 201427 May 2020

First posted4 Apr 2014 (estimated)
Study start30 Oct 2014
Primary completion27 May 2020
Study completion27 May 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)Studies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Investigator, Outcomes assessor
Enrolment: 13,078 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104817
Sponsor's protocol ID: D5881C00004
Other IDs: 2014-001069-28, 2014
Acronym: STRENGTH
Status last verified: Aug 2021
First submitted: 2 Apr 2014
Last updated: 17 Aug 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Publications

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.
PubMed 33993205
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.
PubMed 33190147

Study at a glance

From the registry record, last updated by the sponsor on 17 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
ClinicalTrials.gov ID: NCT02104817
Acronym / sponsor ID: STRENGTH / D5881C00004
Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Keywords: omega-3 carboxylic acid
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 13,078 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: The Cleveland Clinic, IQVIA RDS Inc.
Study start: 30 Oct 2014 (actual)
Primary completion: 27 May 2020 (actual)
Study completion: 27 May 2020 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Posted 28 Jul 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
EPANOVA	Experimental	Drug: Epanova® (omega-3 carboxylic acids)Epanova + statin, once daily
Corn oil	Active comparator	Drug: corn oil controlCorn oil + Statin

Who may qualify

Ages: 18 to 99 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Men or women, ≥18 years of age.
Patient must be on a stable diet and statin* therapy at least 4 weeks prior to randomization (Visit 2) and meet the following criteria:
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:

Key exclusion criteria (1 listed)

1. Allergy or intolerance to omega-3 carboxylic acids, omega-3 fatty acids, omega-3-acid ethyl esters, or corn oil. 2.Use of fibrates, bile acid sequestrants, or niacin or its analogues (>250 mg/day) within 4 weeks prior to Visit 2. 3.Statin naïve at Visit 1.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Epanova® (omega-3 carboxylic acids)Also: omega-3 carboxylic acidsAdjunct to statin therapy and diet in high risk adult patients for the prevention and reduction of major adverse cardiovascular events (MACE)	Drug	EPANOVA
corn oil controlcorn oil control arm	Drug	Corn oil

Primary outcome

The Composite of Major Adverse Cardiovascular Events (MACE)
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
MACE components include: cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, emergent/elective coronary revascularization, or hospitalization for unstable angina. Participants with no observed events are censored at the earliest of withdrawal of consent date and last study contact (defined as the latest of the dates of assessments contributing to an opportunity to assess as to whether the participant has had every component of the endpoint being analyzed).

9 secondary outcomes

The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
CV Death
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
CV Death in the Subgroup of Participants With Established CVD at Baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
All-cause Death
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
All-cause Death in the Subgroup of Participants With Established CVD at Baseline
Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Results and safety

Results posted to the registry on 28 Jul 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Epanova	6,539	80
Placebo	6,539	92

Primary outcome: The Composite of Major Adverse Cardiovascular Events (MACE)

Time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure. Number. Unit: Number of Participants

Measure	Epanova n = 6539	Placebo n = 6539
Value	785	795

Epanova vs Placebo: Hazard Ratio (HR): 0.99 (95% CI 0.90 to 1.09), p = 0.837, Regression, Cox

Population analysed: Full Analysis Set

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Predefined non-SAEs were collected from date of first IP dose until final visit/up to Month 60; if study treatment was discontinued prematurely, non-SAEs were recorded for ≤ 30 days after last IP dose. For AEs that are considered serious, lead to discontinuation, or result in dose modification, overdose, new onset diabetes mellitus, TIA, PHL cases or bleeding- related events were captured from date of first IP dose until final visit/up to Month 60, whether or not the participant discontinued IP.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Epanova	2,259 of 6,532 (34.6%)	1,405 of 6,532 (21.5%)	373 of 6,539
Placebo	2,195 of 6,535 (33.6%)	826 of 6,535 (12.6%)	333 of 6,539

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 33993205Nissen 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.
Derived from this study: PubMed 33190147Nicholls 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.
redacted CSPLink provided by the sponsor.
redacted SAPLink provided by the sponsor.
Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Steven Nissen, MD principal investigator

The Cleveland Clinic

Michael Lincoff, MD principal investigator

The Cleveland Clinic

Stephen Nicholls, MD principal investigator

MonashHeart

684 sites in 22 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 684 sites in United States, Japan, South Africa, China, Hungary and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 28 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Composite of Major Adverse Cardiovascular Events (MACE) (time frame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104817, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2021.