Clinical trial NCT02104817: Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Official title: A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD)
Keywords: omega-3 carboxylic acid
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
Collaborators: name: The Cleveland Clinic
name: IQVIA RDS Inc.
First posted: 2014-04-04
Enrollment: 13078
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 determined when the number of MACE outcomes is reached.


Eligibility criteria: 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.

Primary outcomes:
measure: The Composite of Major Adverse Cardiovascular Events (MACE)
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcomes:
measure: The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: The Composite of CV Events
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: The Composite of Coronary Events
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: CV Death
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: CV Death in the Subgroup of Participants With Established CVD at Baseline
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: All-cause Death
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: All-cause Death in the Subgroup of Participants With Established CVD at Baseline
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Other outcomes:
measure: Emergent/Elective Coronary Revascularization
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: Hospitalization for Unstable Angina
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: Non-fatal Myocardial Infarction
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
measure: Non-fatal Stroke
timeFrame: From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Locations:
city: Birmingham
country: United States
facility: Research Site
state: Alabama
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Yokohama-shi
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facility: Research Site
city: Busan
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facility: Research Site
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facility: Research Site
city: Incheon
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facility: Research Site
city: Seongnam-si
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facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Seoul
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facility: Research Site
city: Seoul
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facility: Research Site
city: Ulsan
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Chihuahua
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facility: Research Site
city: Cuautitlan Izcalli
country: Mexico
facility: Research Site
city: Culiacan
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Guadalajara
country: Mexico
facility: Research Site
city: Merida
country: Mexico
facility: Research Site
city: Mexico
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facility: Research Site
city: Monterrey
country: Mexico
facility: Research Site
city: Zapopan, Jalisco
country: Mexico
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city: Almelo
country: Netherlands
facility: Research Site
city: Almere
country: Netherlands
facility: Research Site
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country: Netherlands
facility: Research Site
city: Amsterdam
country: Netherlands
facility: Research Site
city: Apeldoorn
country: Netherlands
facility: Research Site
city: Arnhem
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facility: Research Site
city: Beek
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facility: Research Site
city: Delft
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facility: Research Site
city: EDE
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Eindhoven
country: Netherlands
facility: Research Site
city: Harderwijk
country: Netherlands
facility: Research Site
city: Heerlen
country: Netherlands
facility: Research Site
city: Hilversum
country: Netherlands
facility: Research Site
city: Hoofddorp
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facility: Research Site
city: Hoogeveen
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facility: Research Site
city: Hoorn
country: Netherlands
facility: Research Site
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country: Netherlands
facility: Research Site
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facility: Research Site
city: Rotterdam
country: Netherlands
facility: Research Site
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country: Netherlands
facility: Research Site
city: Sneek
country: Netherlands
facility: Research Site
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country: Netherlands
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country: Netherlands
facility: Research Site
city: Utrecht
country: Netherlands
facility: Research Site
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country: Netherlands
facility: Research Site
city: Zoetermeer
country: Netherlands
facility: Research Site
city: Zwijndrecht
country: Netherlands
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country: New Zealand
facility: Research Site
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country: New Zealand
facility: Research Site
city: Auckland
country: New Zealand
facility: Research Site
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country: New Zealand
facility: Research Site
city: Christchurch
country: New Zealand
facility: Research Site
city: Havelock North
country: New Zealand
facility: Research Site
city: Rotorua
country: New Zealand
facility: Research Site
city: Wellington
country: New Zealand
facility: Research Site
city: Białystok
country: Poland
facility: Research Site
city: Chorzów
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Gdańsk
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facility: Research Site
city: Gdańsk
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Lodz
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facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Oświęcim
country: Poland
facility: Research Site
city: Parczew
country: Poland
facility: Research Site
city: Piaseczno
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Poznań
country: Poland
facility: Research Site
city: Puławy
country: Poland
facility: Research Site
city: Ruda Śląska
country: Poland
facility: Research Site
city: Rzeszów
country: Poland
facility: Research Site
city: Sobótka
country: Poland
facility: Research Site
city: Sopot
country: Poland
facility: Research Site
city: Staszów
country: Poland
facility: Research Site
city: Toruń
country: Poland
facility: Research Site
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country: Poland
facility: Research Site
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facility: Research Site
city: Wrocław
country: Poland
facility: Research Site
city: Zamość
country: Poland
facility: Research Site
city: Zgierz
country: Poland
facility: Research Site
city: Łódź
country: Poland
facility: Research Site
city: Barnaul
country: Russian Federation
facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Russian Federation
facility: Research Site
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country: Russian Federation
facility: Research Site
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country: Russian Federation
facility: Research Site
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country: Russian Federation
facility: Research Site
city: Saint Petersburg
country: Russian Federation
facility: Research Site
city: Saint-Petersburg
country: Russian Federation
facility: Research Site
city: St Petersburg
country: Russian Federation
facility: Research Site
city: St-Petersburg
country: Russian Federation
facility: Research Site
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country: Russian Federation
facility: Research Site
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country: Russian Federation
facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: South Africa
facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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facility: Research Site
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country: Taiwan
facility: Research Site
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facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
country: Taiwan
facility: Research Site
city: Taipei
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facility: Research Site
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facility: Research Site
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facility: Research Site
city: Kharkiv Region
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facility: Research Site
city: Kharkiv Region
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facility: Research Site
city: Kharkiv Region
country: Ukraine
facility: Research Site
city: Kharkiv Region
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facility: Research Site
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facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
city: Lutsk
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Lviv
country: Ukraine
facility: Research Site
city: Mykolaiv
country: Ukraine
facility: Research Site
city: Odesa
country: Ukraine
facility: Research Site
city: Poltava
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Uzhhorod
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Vinnytsia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Zaporizhzhia
country: Ukraine
facility: Research Site
city: Zhytomyr
country: Ukraine
facility: Research Site
city: Airdrie
country: United Kingdom
facility: Research Site
city: Bournemouth
country: United Kingdom
facility: Research Site
city: Cardiff
country: United Kingdom
facility: Research Site
city: Chelmsford
country: United Kingdom
facility: Research Site
city: Chorley
country: United Kingdom
facility: Research Site
city: East Kilbride
country: United Kingdom
facility: Research Site
city: Edgbaston
country: United Kingdom
facility: Research Site
city: Edinburgh
country: United Kingdom
facility: Research Site
city: Exeter
country: United Kingdom
facility: Research Site
city: Glasgow
country: United Kingdom
facility: Research Site
city: Hexham
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: Liverpool
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: London
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
city: Reading
country: United Kingdom
facility: Research Site
city: Romford
country: United Kingdom
facility: Research Site
city: Stevenage
country: United Kingdom
facility: Research Site
city: Swansea
country: United Kingdom
facility: Research Site
city: Torquay
country: United Kingdom
facility: Research Site
Study officials:
affiliation: The Cleveland Clinic
name: Steven Nissen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Michael Lincoff, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: MonashHeart
name: Stephen Nicholls, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.