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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT02104817




Registration number
NCT02104817
Ethics application status
Date submitted
2/04/2014
Date registered
4/04/2014

Titles & IDs
Public title
Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh CV Risk PatienTs With Hypertriglyceridemia
Scientific title
A Long-Term Outcomes Study to Assess STatin Residual Risk Reduction With EpaNova in HiGh Cardiovascular Risk PatienTs With Hypertriglyceridemia (STRENGTH)
Secondary ID [1] 0 0
2014-001069-28
Secondary ID [2] 0 0
D5881C00004
Universal Trial Number (UTN)
Trial acronym
STRENGTH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eligible Men or Women Considered High Risk for Atherosclerotic Cardiovascular Disease (CVD) 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Diseases of the vasculature and circulation including the lymphatic system
Metabolic and Endocrine 0 0 0 0
Other metabolic disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Epanova® (omega-3 carboxylic acids)
Treatment: Drugs - corn oil control

Experimental: EPANOVA - Epanova + statin, once daily

Active comparator: Corn oil - Corn oil + Statin


Treatment: Drugs: 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)

Treatment: Drugs: corn oil control
corn oil control arm
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
The Composite of Major Adverse Cardiovascular Events (MACE)
Timepoint [1] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [1] 0 0
The Composite of MACE in the Subgroup of Participants With Established CV Disease(CVD) at Baseline
Timepoint [1] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [2] 0 0
The Composite of CV Events
Timepoint [2] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [3] 0 0
The Composite of CV Events in the Subgroup of Participants With Established CV Disease (CVD) at Baseline
Timepoint [3] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [4] 0 0
The Composite of Coronary Events
Timepoint [4] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [5] 0 0
The Composite of Coronary Events in the Subgroup of Participants With Established CVD at Baseline
Timepoint [5] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [6] 0 0
CV Death
Timepoint [6] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [7] 0 0
CV Death in the Subgroup of Participants With Established CVD at Baseline
Timepoint [7] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [8] 0 0
All-cause Death
Timepoint [8] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure
Secondary outcome [9] 0 0
All-cause Death in the Subgroup of Participants With Established CVD at Baseline
Timepoint [9] 0 0
From the date of randomization and up to completion of the end-of-treatment visit (Month 60) or at study closure

Eligibility
Key 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
Minimum age
18 Years
Maximum age
99 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
30/10/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
27/05/2020
Sample size
Target
Accrual to date
Final
13078
Recruitment in Australia
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Research Site - Blacktown
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Research Site - Wollongong
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5000 - Adelaide
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2148 - Blacktown
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3128 - Box Hill
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2794 - Cowra
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2871 - Forbes
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6160 - Fremantle
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4029 - Herston
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6027 - Joondalup
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2035 - Maroubra
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4064 - Milton
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4101 - South Brisbane
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4215 - Southport
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2500 - Wollongong
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Monterrey
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Hoofddorp
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Netherlands
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Maastricht
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Tilburg
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Netherlands
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Netherlands
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Netherlands
State/province [241] 0 0
Zwijndrecht
Country [242] 0 0
New Zealand
State/province [242] 0 0
Auckland
Country [243] 0 0
New Zealand
State/province [243] 0 0
Christchurch
Country [244] 0 0
New Zealand
State/province [244] 0 0
Havelock North
Country [245] 0 0
New Zealand
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Rotorua
Country [246] 0 0
New Zealand
State/province [246] 0 0
Wellington
Country [247] 0 0
Poland
State/province [247] 0 0
Bialystok
Country [248] 0 0
Poland
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Chorzów
Country [249] 0 0
Poland
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Elblag
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Poland
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Gdansk
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Poland
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Gdynia
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Poland
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Katowice
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Poland
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Kraków
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Breyton
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Brits
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Durban
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George
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South Africa
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Paarl
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United Kingdom
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United Kingdom
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Edinburgh
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Exeter
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United Kingdom
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Glasgow
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Hexham
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Leicester
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Liverpool
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United Kingdom
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London
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Manchester
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Romford
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Stevenage
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Swansea
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Torquay

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AstraZeneca
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Cleveland Clinic
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
IQVIA RDS Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Steven Nissen, MD
Address 0 0
The Cleveland Clinic
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
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.

Supporting document/s available: Study protocol, Statistical analysis plan (SAP)
When will data be available (start and end dates)?
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.
Available to whom?
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.
Available for what types of analyses?
How or where can data be obtained?
IPD available at link: https://astrazenecagroup-dt.pharmacm.com/DT/Home


What supporting documents are/will be available?




Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT02104817