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

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

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 determined when the number of MACE outcomes is reached.

Study Overview

• Status: Completed
• Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
• Intervention / Treatment: Drug: Epanova® (omega-3 carboxylic acids); Drug: corn oil control

• Study Type: Interventional
• Enrollment (Actual): 13078
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • Adelaide, Australia, 5000
    • Research Site
  • Blacktown, Australia, 2148
    • Research Site
  • Box Hill, Australia, 3128
    • Research Site
  • Cowra, Australia, 2794
    • Research Site
  • Forbes, Australia, 2871
    • Research Site
  • Fremantle, Australia, 6160
    • Research Site
  • Herston, Australia, 4029
    • Research Site
  • Joondalup, Australia, 6027
    • Research Site
  • Maroubra, Australia, 2035
    • Research Site
  • Milton, Australia, 4064
    • Research Site
  • South Brisbane, Australia, 4101
    • Research Site
  • Southport, Australia, 4215
    • Research Site
  • Tumbi Umbi, Australia, 2261
    • Research Site
  • Wollongong, Australia, 2500
    • Research Site
• Belgium
  • Aalst, Belgium, 9300
    • Research Site
  • Antwerpen, Belgium, 2060
    • Research Site
  • Brugge, Belgium, 8000
    • Research Site
  • Brussels, Belgium, 1070
    • Research Site
  • Bruxelles, Belgium, 1200
    • Research Site
  • Genk, Belgium, 3600
    • Research Site
  • Halen, Belgium, 3545
    • Research Site
  • Leuven, Belgium, 3000
    • Research Site
  • Liège, Belgium, 4000
    • Research Site
  • Mol, Belgium, 2400
    • Research Site
  • Mons, Belgium, 7000
    • Research Site
• Canada
  • Quebec, Canada, G1W 4R4
    • Research Site
  • Quebec, Canada, G1G 4A2
    • Research Site
  • British Columbia
    • New Westminster, British Columbia, Canada, V3L 3W4
      • Research Site
    • Vancouver, British Columbia, Canada, V5E 4E1
      • Research Site
  • Ontario
    • Barrie, Ontario, Canada, L4M 7G1
      • Research Site
    • Brampton, Ontario, Canada, L6Z 4N5
      • Research Site
    • Cambridge, Ontario, Canada, N1R 3G2
      • Research Site
    • Etobicoke, Ontario, Canada, M9R 4E1
      • Research Site
    • Newmarket, Ontario, Canada, L3Y 5G8
      • Research Site
    • North York, Ontario, Canada, M3M 3E5
      • Research Site
    • Peterborough, Ontario, Canada, K9J 0B2
      • Research Site
    • Thornhill, Ontario, Canada, L4J 8L7
      • Research Site
    • Toronto, Ontario, Canada, M9V 4B4
      • Research Site
    • Toronto, Ontario, Canada, L6H 3P1
      • Research Site
    • Toronto, Ontario, Canada, M5N 1C1
      • Research Site
  • Quebec
    • Granby, Quebec, Canada, J2G 8Z9
      • Research Site
    • Laval, Quebec, Canada, H7T 2P5
      • Research Site
    • Longueuil, Quebec, Canada, J4M 2X1
      • Research Site
    • Mirabel, Quebec, Canada, J7J 2K8
      • Research Site
    • Sherbrooke, Quebec, Canada, J1L 0H8
      • Research Site
• China
  • Beijing, China, 100070
    • Research Site
  • Beijing, China, 100044
    • Research Site
  • Beijing, China, 100035
    • Research Site
  • Changchun, China, 130021
    • Research Site
  • Changchun, China, 130033
    • Research Site
  • Changsha, China, 410013
    • Research Site
  • Changsha, China, 410011
    • Research Site
  • Chengdu, China, 610041
    • Research Site
  • Chongqing, China, 400010
    • Research Site
  • Guangzhou, China, 510080
    • Research Site
  • Guangzhou, China, 510100
    • Research Site
  • Guangzhou, China, 510515
    • Research Site
  • Guangzhou, China, 510630
    • Research Site
  • Haerbin, China, 150001
    • Research Site
  • Haikou, China, 570102
    • Research Site
  • Hohhot, China, 010017
    • Research Site
  • Jilin, China, 132000
    • Research Site
  • Lanzhou, China, 730030
    • Research Site
  • Nanchang, China, 330006
    • Research Site
  • Nanjing, China, 210011
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  • Nanning, China, 530021
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  • Shanghai, China, 200025
    • Research Site
  • Shanghai, China, 200062
    • Research Site
  • Shanghai, China, 200065
    • Research Site
  • Shanghai, China, 200090
    • Research Site
  • Shenyang, China, 110001
    • Research Site
  • Suzhou, China, 215028
    • Research Site
  • Taiyuan, China, 030001
    • Research Site
  • Tianjin, China, 300052
    • Research Site
  • Tianjin, China, 300457
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  • Urumqi, China, 830054
    • Research Site
  • Xian, China, 710061
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  • Xuzhou, China, 221006
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  • Yanji, China, 133000
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  • Yinchuan, China, 750004
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  • Yueyang, China, 414000
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  • Zhanjiang, China, 524001
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  • Zhenjiang, China, 212002
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• Czechia
  • Beroun, Czechia, 266 01
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  • Brno, Czechia, 656 91
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  • Brno, Czechia, 615 00
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  • Chocen, Czechia, 565 01
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  • Chrudim, Czechia, 537 02
    • Research Site
  • Hodonin, Czechia, 695 01
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  • Hostivice, Czechia, 253 01
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  • Hradec Kralove, Czechia, 500 05
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  • Hradec Kralove, Czechia, 500 02
    • Research Site
  • Jindrichuv Hradec, Czechia, 377 01
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  • Olomouc, Czechia, 77900
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  • Ostrava, Czechia, 702 00
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  • Pardubice, Czechia, 530 02
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  • Praha, Czechia, 140 59
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  • Praha 10 - Strasnice, Czechia, 100 00
    • Research Site
  • Praha 5, Czechia, 150 06
    • Research Site
  • Praha 5, Czechia, 158 00
    • Research Site
  • Praha 8, Czechia, 181 00
    • Research Site
  • Prerov, Czechia, 750 00
    • Research Site
  • Slany, Czechia, 274 01
    • Research Site
  • Tremosna, Czechia, 33011
    • Research Site
  • Trutnov, Czechia, 541 01
    • Research Site
  • Zlin, Czechia, 762 75
    • Research Site
• Denmark
  • Hellerup, Denmark, 2900
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  • Herlev, Denmark, 2730
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  • København Ø, Denmark, 2100
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  • Svendborg, Denmark, 5700
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  • Viborg, Denmark, 8800
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  • Ålborg, Denmark, 9100
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  • Århus N, Denmark, 8200
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• Estonia
  • Haabneeme, Estonia, 74001
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  • Pärnu, Estonia, 80018
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  • Tallinn, Estonia, 01138
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  • Tallinn, Estonia, 10617
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  • Tallinn, Estonia, 13419
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  • Tartu, Estonia, 50107
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  • Tartu, Estonia, 50406
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• Hungary
  • Baja, Hungary, 6500
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  • Balatonfured, Hungary, 8230
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  • Balatongyorok, Hungary, 8313
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  • Ballasagyarmat, Hungary, 2660
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  • Budapest, Hungary, 1083
    • Research Site
  • Budapest, Hungary, 1125
    • Research Site
  • Budapest, Hungary, 1122
    • Research Site
  • Budapest, Hungary, 1135
    • Research Site
  • Budapest, Hungary, 1134
    • Research Site
  • Budapest, Hungary, 1033
    • Research Site
  • Budapest, Hungary, 1036
    • Research Site
  • Békéscsaba, Hungary, 5600
    • Research Site
  • Csorna, Hungary, 9300
    • Research Site
  • Debrecen, Hungary, 4032
    • Research Site
  • Debrecen, Hungary, 4025
    • Research Site
  • Eger, Hungary, 3300
    • Research Site
  • Godollo, Hungary, 2100
    • Research Site
  • Gyula, Hungary, 5700
    • Research Site
  • Gödöllő, Hungary, 2100
    • Research Site
  • Hajdúszoboszló, Hungary, 4200
    • Research Site
  • Hatvan, Hungary, 3000
    • Research Site
  • Kalocsa, Hungary, 6300
    • Research Site
  • Kiskunhalas, Hungary, 6400
    • Research Site
  • Komarom, Hungary, 2921
    • Research Site
  • Létavértes, Hungary, 4281
    • Research Site
  • Mohacs, Hungary, 7700
    • Research Site
  • Nagykanizsa, Hungary, 8800
    • Research Site
  • Nyiregyhaza, Hungary, 4405
    • Research Site
  • Nyíregyháza, Hungary, 4400
    • Research Site
  • Szeged, Hungary, 6720
    • Research Site
  • Szeged, Hungary, 6722
    • Research Site
  • Szekszárd, Hungary, 7100
    • Research Site
  • Szentes, Hungary, 6600
    • Research Site
  • Székesfehérvár, Hungary, 8000
    • Research Site
  • Veszprem, Hungary, 8200
    • Research Site
  • Zalaegerszeg, Hungary, 8900
    • Research Site
• Italy
  • Bergamo, Italy, 24127
    • Research Site
  • Bologna, Italy, 40138
    • Research Site
  • Brescia, Italy, 25100
    • Research Site
  • Cinisello Balsamo, Italy, 20092
    • Research Site
  • Cona, Italy, 44124
    • Research Site
  • L'Aquila, Italy, 67100
    • Research Site
  • Milano, Italy, 20132
    • Research Site
  • Milano, Italy, 20162
    • Research Site
  • Milano, Italy, 20138
    • Research Site
  • Napoli, Italy, 80131
    • Research Site
  • Parma, Italy, 43100
    • Research Site
  • Pavia, Italy, 27100
    • Research Site
  • Perugia, Italy, 06156
    • Research Site
  • Roma, Italy, 00133
    • Research Site
  • San Giovanni Rotondo, Italy, 71013
    • Research Site
  • Trieste, Italy, 34142
    • Research Site
• Japan
  • Adachi-ku, Japan, 120-0006
    • Research Site
  • Adachi-ku, Japan, 120-0022
    • Research Site
  • Akishima-shi, Japan, 196-0003
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  • Akita-shi, Japan, 010-1423
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  • Amagasaki-shi, Japan, 660-0807
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  • Chikushi-gun, Japan, 811-1244
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  • Chikushino-shi, Japan, 818-8516
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  • Chuo-ku, Japan, 104-0031
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  • Chuo-ku, Japan, 103-0027
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  • Fujisawa-shi, Japan, 251-8550
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  • Gifu-shi, Japan, 500-8384
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  • Hachioji-shi, Japan, 192-0918
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  • Hachioji-shi, Japan, 193-0811
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  • Hakusan-shi, Japan, 924-8588
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  • Ichikawa-shi, Japan, 272-8516
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  • Imabari-shi, Japan, 794-0006
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  • Itoshima-shi, Japan, 819-1104
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  • Kasugai-shi, Japan, 487-0031
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  • Kawanishi-shi, Japan, 666-0125
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  • Kishiwada-shi, Japan, 596-8522
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  • Kitakyushu-shi, Japan, 802-0001
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  • Kochi-shi, Japan, 780-8522
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  • Kyoto-shi, Japan, 607-8062
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  • Maebashi-shi, Japan, 371-0004
    • Research Site
  • Matsudo-shi, Japan, 270-2251
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  • Matsumoto-shi, Japan, 390-1401
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  • Matsuyama-shi, Japan, 790-0067
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  • Meguro-ku, Japan, 153-0051
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  • Minato-ku, Japan, 108-0075
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  • Nagoya-shi, Japan, 462-0825
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  • Nakagami-gun, Japan, 901-2393
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  • Niigata-shi, Japan, 956-0025
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  • Oita-shi, Japan, 870-0192
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  • Onga-gun, Japan, 807-0051
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  • Osaka-shi, Japan, 530-0001
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  • Osaka-shi, Japan, 532-0003
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  • Saga-shi, Japan, 849-0917
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  • Sapporo-shi, Japan, 003-0026
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  • Sapporo-shi, Japan, 006-0811
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  • Sapporo-shi, Japan, 060-0031
    • Research Site
  • Sendai-shi, Japan, 980-0803
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  • Shinagawa-ku, Japan, 141-0032
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  • Shinjuku-ku, Japan, 169-0073
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  • Takamatsu-shi, Japan, 760-8538
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  • Takasaki-shi, Japan, 370-0036
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  • Tokorozawa-shi, Japan, 359-1141
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  • Toshima-ku, Japan, 171-0014
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  • Tsuchiura-shi, Japan, 300-0028
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  • Yokohama-shi, Japan, 236-0004
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  • Yokohama-shi, Japan, 231-8682
    • Research Site
• Korea, Republic of
  • Busan, Korea, Republic of, 47392
    • Research Site
  • Busan, Korea, Republic of, 49201
    • Research Site
  • Gwangju, Korea, Republic of, 501-757
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  • Incheon, Korea, Republic of, 405-760
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  • Seongnam-si, Korea, Republic of, 13620
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  • Seoul, Korea, Republic of, 03722
    • Research Site
  • Seoul, Korea, Republic of, 05505
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  • Seoul, Korea, Republic of, 03080
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  • Seoul, Korea, Republic of, 06351
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  • Seoul, Korea, Republic of, 06591
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  • Seoul, Korea, Republic of, 03312
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  • Seoul, Korea, Republic of, 05278
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  • Seoul, Korea, Republic of, 07061
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  • Ulsan, Korea, Republic of, 44033
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• Lithuania
  • Alytus, Lithuania, 62381
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  • Kaunas, Lithuania, 50009
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  • Kaunas, Lithuania, 48259
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  • Kaunas, Lithuania, 49387
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  • Kaunas, Lithuania, 49449
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  • Kaunas, Lithuania, LT-47144
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  • Klaipeda, Lithuania, 91131
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  • Klaipeda, Lithuania, LT-92231
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  • Panevezys, Lithuania, 35144
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  • Siauliai, Lithuania, LT-76231
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  • Vilnius, Lithuania, 08661
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• Mexico
  • Chihuahua, Mexico, 31237
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  • Cuautitlan Izcalli, Mexico, 54769
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  • Culiacan, Mexico, 80230
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  • Guadalajara, Mexico, 44670
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  • Guadalajara, Mexico, 44130
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  • Guadalajara, Mexico, 44150
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  • Merida, Mexico, 97129
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  • Mexico, Mexico, 06700
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  • Monterrey, Mexico, 64710
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  • Zapopan, Jalisco, Mexico, 45200
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• Netherlands
  • Almelo, Netherlands, 7600SZ
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  • Almere, Netherlands, 1311 RL
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  • Amsterdam, Netherlands, 1105 AZ
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  • Amsterdam, Netherlands, 1061 AE
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  • Apeldoorn, Netherlands, 7334 DZ
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  • Arnhem, Netherlands, 6815 AD
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  • Beek, Netherlands, 6191 JW
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  • Delft, Netherlands, 2625 AD
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  • EDE, Netherlands, 6716 RP
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  • Eindhoven, Netherlands, 5611 NV
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  • Eindhoven, Netherlands, 5623EJ
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  • Harderwijk, Netherlands, 3844 DG
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  • Heerlen, Netherlands, 6419 PC
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  • Hilversum, Netherlands, 1213 XZ
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  • Hoofddorp, Netherlands, 2134 TM
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  • Hoogeveen, Netherlands, 7909 AA
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  • Hoorn, Netherlands, 1625 HV
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  • Maastricht, Netherlands, 6229 HX
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  • Nijmegen, Netherlands, 6525 EC
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  • Rotterdam, Netherlands, 3021 HC
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  • Rotterdam, Netherlands, 3045 PM
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  • Schiedam, Netherlands, 3118 JH
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  • Sneek, Netherlands, 8601 ZK
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  • Tilburg, Netherlands, 5042AD
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  • Utrecht, Netherlands, 3584 CX
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  • Utrecht, Netherlands, 3511 NH
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  • Venlo, Netherlands, 5912 BL
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  • Zoetermeer, Netherlands, 2725 NA
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  • Zwijndrecht, Netherlands, 3331 LZ
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• New Zealand
  • Auckland, New Zealand, 1023
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  • Auckland, New Zealand, 2025
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  • Auckland, New Zealand, 0626
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  • Christchurch, New Zealand, 8011
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  • Christchurch, New Zealand, 8024
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  • Havelock North, New Zealand, 4130
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  • Rotorua, New Zealand, 3010
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  • Wellington, New Zealand, 6011
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• Poland
  • Białystok, Poland, 15-879
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  • Chorzów, Poland, 41-500
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  • Elbląg, Poland, 82-300
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  • Gdańsk, Poland, 80-952
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  • Gdańsk, Poland, 80-286
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  • Gdańsk, Poland, 80-382
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  • Gdynia, Poland, 81-157
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• Russian Federation
  • Barnaul, Russian Federation, 656055
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  • Kemerovo, Russian Federation, 650066
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  • Kemerovo, Russian Federation, 650000
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  • Kemerovo, Russian Federation, 650002
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  • Moscow, Russian Federation, 125367
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  • Moscow, Russian Federation, 107014
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  • Moscow, Russian Federation, 117556
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  • Moscow, Russian Federation, 121374
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  • Moscow, Russian Federation, 127473
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  • Novosibirsk, Russian Federation, 630008
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  • Novosibirsk, Russian Federation, 630047
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  • Novosibirsk, Russian Federation, 630054
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  • Novosibirsk, Russian Federation, 630089
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  • Saint Petersburg, Russian Federation, 196247
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  • St Petersburg, Russian Federation, 197341
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• South Africa
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  • Soweto, South Africa, 2013
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• Taiwan
  • Kaohsiung, Taiwan
    • Research Site
  • Kaohsiung, Taiwan, 80756
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  • Taipei, Taiwan, 11101
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• Ukraine
  • Cherkasy, Ukraine, 18009
    • Research Site
  • Ivano-Frankivsk, Ukraine, 76005
    • Research Site
  • Kharkiv Region, Ukraine, 61039
    • Research Site
  • Kharkiv Region, Ukraine, 61103
    • Research Site
  • Kharkiv Region, Ukraine, 61157
    • Research Site
  • Kharkiv Region, Ukraine, 61176
    • Research Site
  • Kyiv, Ukraine, 01601
    • Research Site
  • Kyiv, Ukraine, 04114
    • Research Site
  • Kyiv, Ukraine, 01103
    • Research Site
  • Kyiv, Ukraine, 02002
    • Research Site
  • Kyiv, Ukraine, 02091
    • Research Site
  • Kyiv, Ukraine, 02232
    • Research Site
  • Kyiv, Ukraine, 02660
    • Research Site
  • Kyiv, Ukraine, 03037
    • Research Site
  • Kyiv, Ukraine, 03049
    • Research Site
  • Kyiv, Ukraine, 03115
    • Research Site
  • Kyiv, Ukraine, 03680
    • Research Site
  • Lutsk, Ukraine, 43024
    • Research Site
  • Lviv, Ukraine, 79059
    • Research Site
  • Lviv, Ukraine, 79034
    • Research Site
  • Mykolaiv, Ukraine, 54003
    • Research Site
  • Odesa, Ukraine, 65114
    • Research Site
  • Poltava, Ukraine, 36011
    • Research Site
  • Uzhhorod, Ukraine, 88009
    • Research Site
  • Uzhhorod, Ukraine, 88014
    • Research Site
  • Vinnytsia, Ukraine, 21029
    • Research Site
  • Vinnytsia, Ukraine, 21018
    • Research Site
  • Zaporizhzhia, Ukraine, 69001
    • Research Site
  • Zaporizhzhia, Ukraine, 69096
    • Research Site
  • Zhytomyr, Ukraine, 10002
    • Research Site
• United Kingdom
  • Airdrie, United Kingdom, ML6 0JS
    • Research Site
  • Bournemouth, United Kingdom, BH7 7DW
    • Research Site
  • Cardiff, United Kingdom, CF14 5GJ
    • Research Site
  • Chelmsford, United Kingdom, CM1 7ET
    • Research Site
  • Chorley, United Kingdom, PR7 7NA
    • Research Site
  • East Kilbride, United Kingdom, G75 8RG
    • Research Site
  • Edgbaston, United Kingdom, B15 2SQ
    • Research Site
  • Edinburgh, United Kingdom, EH16 4SA
    • Research Site
  • Exeter, United Kingdom, EX2 5DW
    • Research Site
  • Glasgow, United Kingdom, G20 OSP
    • Research Site
  • Hexham, United Kingdom, NE46 1QJ
    • Research Site
  • Leicester, United Kingdom, LE3 9QP
    • Research Site
  • Liverpool, United Kingdom, L7 8XP
    • Research Site
  • Liverpool, United Kingdom, L22 0LG
    • Research Site
  • London, United Kingdom, NW3 2QG
    • Research Site
  • London, United Kingdom, EC1M 6BQ
    • Research Site
  • Manchester, United Kingdom, M15 6SX
    • Research Site
  • Reading, United Kingdom, RG2 0TG
    • Research Site
  • Romford, United Kingdom, RM7 0AG
    • Research Site
  • Stevenage, United Kingdom, SG1 4AB
    • Research Site
  • Swansea, United Kingdom, SA6 6NL
    • Research Site
  • Torquay, United Kingdom, TQ2 7AA
    • Research Site
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35205
      • Research Site
    • Birmingham, Alabama, United States, 35235
      • Research Site
    • Birmingham, Alabama, United States, 35211
      • Research Site
    • Birmingham, Alabama, United States, 35233
      • Research Site
    • Huntsville, Alabama, United States, 35801
      • Research Site
    • Muscle Shoals, Alabama, United States, 35662
      • Research Site
  • Arizona
    • Chandler, Arizona, United States, 85224
      • Research Site
    • Gilbert, Arizona, United States, 85295
      • Research Site
    • Glendale, Arizona, United States, 85308
      • Research Site
    • Mesa, Arizona, United States, 85206
      • Research Site
    • Mesa, Arizona, United States, 85213
      • Research Site
    • Phoenix, Arizona, United States, 85032
      • Research Site
    • Tempe, Arizona, United States, 85283
      • Research Site
    • Tucson, Arizona, United States, 85712
      • Research Site
    • Tucson, Arizona, United States, 85741
      • Research Site
    • Tucson, Arizona, United States, 85710
      • Research Site
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Research Site
    • Little Rock, Arkansas, United States, 72211
      • Research Site
  • California
    • Carlsbad, California, United States, 92008
      • Research Site
    • Fresno, California, United States, 93720
      • Research Site
    • Fresno, California, United States, 93721
      • Research Site
    • Greenbrae, California, United States, 94904
      • Research Site
    • Long Beach, California, United States, 90807
      • Research Site
    • Los Angeles, California, United States, 90069
      • Research Site
    • Milpitas, California, United States, 95035
      • Research Site
    • Newport Beach, California, United States, 92663
      • Research Site
    • Northridge, California, United States, 91325-4139
      • Research Site
    • Palm Springs, California, United States, 92262
      • Research Site
    • San Diego, California, United States, 92103-6204
      • Research Site
    • Santa Ana, California, United States, 92705
      • Research Site
    • Santa Rosa, California, United States, 95405
      • Research Site
    • Tarzana, California, United States, 91356
      • Research Site
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Research Site
    • Denver, Colorado, United States, 80239-3133
      • Research Site
    • Denver, Colorado, United States, 80239
      • Research Site
    • Denver, Colorado, United States, 80246
      • Research Site
  • Connecticut
    • Waterbury, Connecticut, United States, 06708
      • Research Site
  • Florida
    • Boca Raton, Florida, United States, 33431
      • Research Site
    • Clearwater, Florida, United States, 33756
      • Research Site
    • Coral Gables, Florida, United States, 33134
      • Research Site
    • Davie, Florida, United States, 33330
      • Research Site
    • Delray Beach, Florida, United States, 33446
      • Research Site
    • Fort Lauderdale, Florida, United States, 33308
      • Research Site
    • Hialeah, Florida, United States, 33012
      • Research Site
    • Homestead, Florida, United States, 33130
      • Research Site
    • Jacksonville, Florida, United States, 32216
      • Research Site
    • Jacksonville, Florida, United States, 32277
      • Research Site
    • Lake Worth, Florida, United States, 33461
      • Research Site
    • Lakeland, Florida, United States, 33805
      • Research Site
    • Miami, Florida, United States, 33173
      • Research Site
    • Miami, Florida, United States, 33176
      • Research Site
    • Miami, Florida, United States, 33142
      • Research Site
    • New Port Richey, Florida, United States, 34652
      • Research Site
    • Pembroke Pines, Florida, United States, 33026
      • Research Site
    • Pembroke Pines, Florida, United States, 33027
      • Research Site
    • Pensacola, Florida, United States, 32501
      • Research Site
    • Pinellas Park, Florida, United States, 33781
      • Research Site
    • Port Charlotte, Florida, United States, 33952
      • Research Site
    • Spring Hill, Florida, United States, 34609
      • Research Site
    • Tamarac, Florida, United States, 33321
      • Research Site
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Research Site
    • Marietta, Georgia, United States, 30067
      • Research Site
    • Sandy Springs, Georgia, United States, 30328
      • Research Site
    • Savannah, Georgia, United States, 31405
      • Research Site
  • Illinois
    • Arlington Heights, Illinois, United States, 60005
      • Research Site
    • Blue Island, Illinois, United States, 60406
      • Research Site
    • Champaign, Illinois, United States, 61820
      • Research Site
    • Chicago, Illinois, United States, 60637
      • Research Site
    • Chicago, Illinois, United States, 60654
      • Research Site
    • Evanston, Illinois, United States, 60201
      • Research Site
    • Naperville, Illinois, United States, 60566-7226
      • Research Site
    • Oakbrook Terrace, Illinois, United States, 60181
      • Research Site
    • Sterling, Illinois, United States, 61081
      • Research Site
  • Indiana
    • Anderson, Indiana, United States, 46011
      • Research Site
    • Avon, Indiana, United States, 46123
      • Research Site
    • Elkhart, Indiana, United States, 46514
      • Research Site
    • Evansville, Indiana, United States, 47714
      • Research Site
    • Evansville, Indiana, United States, 47715
      • Research Site
    • Fort Wayne, Indiana, United States, 46845
      • Research Site
    • Franklin, Indiana, United States, 46131
      • Research Site
    • Greenfield, Indiana, United States, 46140
      • Research Site
    • Muncie, Indiana, United States, 47304
      • Research Site
    • Valparaiso, Indiana, United States, 46383
      • Research Site
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • Research Site
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Research Site
    • Overland Park, Kansas, United States, 66210
      • Research Site
  • Kentucky
    • Louisville, Kentucky, United States, 40213
      • Research Site
  • Louisiana
    • Monroe, Louisiana, United States, 71203
      • Research Site
    • Shreveport, Louisiana, United States, 71101
      • Research Site
    • Slidell, Louisiana, United States, 70458
      • Research Site
  • Maine
    • Auburn, Maine, United States, 04210
      • Research Site
  • Maryland
    • Baltimore, Maryland, United States, 21228
      • Research Site
    • Baltimore, Maryland, United States, 21229
      • Research Site
    • Elkridge, Maryland, United States, 21075
      • Research Site
  • Massachusetts
    • Hyannis, Massachusetts, United States, 02601
      • Research Site
    • Quincy, Massachusetts, United States, 02169
      • Research Site
  • Michigan
    • Bay City, Michigan, United States, 48708
      • Research Site
    • Cadillac, Michigan, United States, 49601
      • Research Site
    • Kalamazoo, Michigan, United States, 49048
      • Research Site
    • Saginaw, Michigan, United States, 48602
      • Research Site
    • Saginaw, Michigan, United States, 48601
      • Research Site
    • Traverse City, Michigan, United States, 49684
      • Research Site
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • Research Site
    • Minneapolis, Minnesota, United States, 55455
      • Research Site
  • Mississippi
    • Port Gibson, Mississippi, United States, 39150
      • Research Site
    • Tupelo, Mississippi, United States, 38801
      • Research Site
  • Missouri
    • Bridgeton, Missouri, United States, 63044
      • Research Site
    • Hazelwood, Missouri, United States, 63042
      • Research Site
  • Nebraska
    • Omaha, Nebraska, United States, 68114
      • Research Site
    • Omaha, Nebraska, United States, 68131
      • Research Site
    • Omaha, Nebraska, United States, 68144
      • Research Site
    • Omaha, Nebraska, United States, 68114-1119
      • Research Site
  • Nevada
    • Las Vegas, Nevada, United States, 89120
      • Research Site
  • New Jersey
    • Bridgewater, New Jersey, United States, 08807
      • Research Site
    • Camden, New Jersey, United States, 08103
      • Research Site
    • Elmer, New Jersey, United States, 08318
      • Research Site
    • Haddon Heights, New Jersey, United States, 08035
      • Research Site
    • Sewell, New Jersey, United States, 08080
      • Research Site
    • Sicklerville, New Jersey, United States, 08081
      • Research Site
  • New York
    • Albany, New York, United States, 12208
      • Research Site
    • Albany, New York, United States, 12205
      • Research Site
    • Albany, New York, United States, 12211
      • Research Site
    • Binghamton, New York, United States, 13901
      • Research Site
    • Laurelton, New York, United States, 11413
      • Research Site
    • Lawrence, New York, United States, 11559
      • Research Site
    • New York, New York, United States, 10029
      • Research Site
    • Saratoga Springs, New York, United States, 12866
      • Research Site
    • Southampton, New York, United States, 11968
      • Research Site
    • Troy, New York, United States, 12180
      • Research Site
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Research Site
    • Cary, North Carolina, United States, 27518
      • Research Site
    • Charlotte, North Carolina, United States, 28277
      • Research Site
    • Charlotte, North Carolina, United States, 28207
      • Research Site
    • Charlotte, North Carolina, United States, 28209
      • Research Site
    • Charlotte, North Carolina, United States, 28204
      • Research Site
    • Greensboro, North Carolina, United States, 27408
      • Research Site
    • Greenville, North Carolina, United States, 27834
      • Research Site
    • Hickory, North Carolina, United States, 28602
      • Research Site
    • Mooresville, North Carolina, United States, 28117
      • Research Site
    • Morganton, North Carolina, United States, 28655
      • Research Site
    • Raleigh, North Carolina, United States, 27607
      • Research Site
    • Rocky Mount, North Carolina, United States, 27804
      • Research Site
    • Salisbury, North Carolina, United States, 28144
      • Research Site
    • Wilmington, North Carolina, United States, 28401
      • Research Site
    • Winston-Salem, North Carolina, United States, 27103
      • Research Site
  • North Dakota
    • Grand Forks, North Dakota, United States, 58201
      • Research Site
  • Ohio
    • Akron, Ohio, United States, 44311
      • Research Site
    • Cincinnati, Ohio, United States, 45236
      • Research Site
    • Cincinnati, Ohio, United States, 45219
      • Research Site
    • Cincinnati, Ohio, United States, 45227
      • Research Site
    • Cincinnati, Ohio, United States, 45246
      • Research Site
    • Cleveland, Ohio, United States, 44195
      • Research Site
    • Columbus, Ohio, United States, 43210
      • Research Site
    • Marion, Ohio, United States, 43302
      • Research Site
    • Maumee, Ohio, United States, 43537
      • Research Site
    • Middleburg Hts, Ohio, United States, 44130
      • Research Site
  • Oklahoma
    • Midwest City, Oklahoma, United States, 73110
      • Research Site
    • Norman, Oklahoma, United States, 73069
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73112-4703
      • Research Site
    • Oklahoma City, Oklahoma, United States, 73135
      • Research Site
  • Oregon
    • Bend, Oregon, United States, 97701
      • Research Site
    • Corvallis, Oregon, United States, 97330
      • Research Site
    • Portland, Oregon, United States, 97239
      • Research Site
    • Portland, Oregon, United States, 97229
      • Research Site
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18103
      • Research Site
    • Beaver, Pennsylvania, United States, 15009
      • Research Site
    • Danville, Pennsylvania, United States, 17822
      • Research Site
    • Doylestown, Pennsylvania, United States, 18901
      • Research Site
    • Ephrata, Pennsylvania, United States, 17522
      • Research Site
    • Flourtown, Pennsylvania, United States, 19031
      • Research Site
    • Johnstown, Pennsylvania, United States, 15905
      • Research Site
    • Natrona Heights, Pennsylvania, United States, 15065
      • Research Site
    • Newport, Pennsylvania, United States, 17011
      • Research Site
    • Philadelphia, Pennsylvania, United States, 19104
      • Research Site
    • Port Matilda, Pennsylvania, United States, 16870-7153
      • Research Site
    • Tipton, Pennsylvania, United States, 16684
      • Research Site
    • Wilkes-Barre, Pennsylvania, United States, 18711
      • Research Site
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • Research Site
    • Charleston, South Carolina, United States, 29425
      • Research Site
    • Charleston, South Carolina, United States, 29407
      • Research Site
    • Fountain Inn, South Carolina, United States, 29681
      • Research Site
    • Greer, South Carolina, United States, 29651
      • Research Site
    • Greer, South Carolina, United States, 29650
      • Research Site
    • Mount Pleasant, South Carolina, United States, 29464
      • Research Site
    • Rock Hill, South Carolina, United States, 29732
      • Research Site
    • Simpsonville, South Carolina, United States, 29681
      • Research Site
    • Spartanburg, South Carolina, United States, 29302
      • Research Site
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Research Site
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Research Site
    • Chattanooga, Tennessee, United States, 37421
      • Research Site
    • Johnson City, Tennessee, United States, 37604
      • Research Site
    • Kingsport, Tennessee, United States, 37660
      • Research Site
    • Knoxville, Tennessee, United States, 37934
      • Research Site
    • Knoxville, Tennessee, United States, 37912
      • Research Site
  • Texas
    • Arlington, Texas, United States, 76012
      • Research Site
    • Austin, Texas, United States, 78758
      • Research Site
    • Corpus Christi, Texas, United States, 78413
      • Research Site
    • Dallas, Texas, United States, 75390
      • Research Site
    • Fort Worth, Texas, United States, 76107
      • Research Site
    • Fort Worth, Texas, United States, 76117
      • Research Site
    • Fort Worth, Texas, United States, 76132
      • Research Site
    • Houston, Texas, United States, 77030
      • Research Site
    • Houston, Texas, United States, 77070
      • Research Site
    • Houston, Texas, United States, 77079
      • Research Site
    • Irving, Texas, United States, 75061
      • Research Site
    • Mission, Texas, United States, 78572
      • Research Site
    • Odessa, Texas, United States, 79761
      • Research Site
    • Plano, Texas, United States, 75093
      • Research Site
    • San Antonio, Texas, United States, 78212
      • Research Site
    • San Antonio, Texas, United States, 78217
      • Research Site
    • San Antonio, Texas, United States, 78228
      • Research Site
    • Victoria, Texas, United States, 77901
      • Research Site
  • Utah
    • Clinton, Utah, United States, 84015
      • Research Site
    • Ogden, Utah, United States, 84405
      • Research Site
    • Orem, Utah, United States, 84058
      • Research Site
    • Salt Lake City, Utah, United States, 84107
      • Research Site
    • Salt Lake City, Utah, United States, 84124
      • Research Site
    • Salt Lake City, Utah, United States, 84102
      • Research Site
  • Virginia
    • Burke, Virginia, United States, 22015
      • Research Site
    • Danville, Virginia, United States, 24541
      • Research Site
    • Herndon, Virginia, United States, 20171
      • Research Site
    • Lynchburg, Virginia, United States, 24501
      • Research Site
    • Manassas, Virginia, United States, 20110
      • Research Site
    • Manassas, Virginia, United States, 20109
      • Research Site
  • Washington
    • Port Orchard, Washington, United States, 98366
      • Research Site
  • Wisconsin
    • Green Bay, Wisconsin, United States, 54301
      • Research Site
    • La Crosse, Wisconsin, United States, 54601
      • Research Site
    • Madison, Wisconsin, United States, 53715
      • Research Site
    • Wausau, Wisconsin, United States, 54401
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Men or women, ≥18 years of age.

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.

Key Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EPANOVA; Epanova + statin, once daily	Drug: 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); Other Names: omega-3 carboxylic acids
Active Comparator: Corn oil; Corn oil + Statin	Drug: corn oil control; corn oil control arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	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).	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).	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).	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	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.	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	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.	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	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emergent/Elective Coronary Revascularization	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).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Non-fatal Myocardial Infarction	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).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
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).	From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: The Cleveland Clinic; IQVIA RDS Inc.
• Investigators: Principal Investigator: Steven Nissen, MD, The Cleveland Clinic; Principal Investigator: Michael Lincoff, MD, The Cleveland Clinic; Principal Investigator: Stephen Nicholls, MD, MonashHeart

Publications and helpful links

General 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 ω-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 May 16. doi: 10.1001/jamacardio.2021.1157. [Epub ahead of print]
• 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.

Helpful Links

• redacted CSP
• redacted SAP

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2014
• Primary Completion (Actual): May 27, 2020
• Study Completion (Actual): May 27, 2020

Study Registration Dates

• First Submitted: April 2, 2014
• First Submitted That Met QC Criteria: April 2, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 16, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Keywords: omega-3 carboxylic acid
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Cardiovascular Diseases; Atherosclerosis; Hypertriglyceridemia
• Other Study ID Numbers: D5881C00004; 2014-001069-28 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

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.

• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved AstraZeneca will provide access to the de-identified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)