Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12614000732684
Ethics application status
Approved
Date submitted
14/05/2014
Date registered
10/07/2014
Date last updated
18/12/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
The Aboriginal Cardiovascular Omega-3 Randomised Controlled Trial
Scientific title
The effect of omega-3 supplementation on adverse cardiovascular (CV) events among Indigenous Australians with stable coronary artery disease: A randomized controlled trial
Secondary ID [1] 284601 0
Nil
Universal Trial Number (UTN)
Nil
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atherosclerosis 291903 0
factors associated with thrombus formation 291904 0
heart rate variability 291905 0
Coronary Artery Disease 292377 0
Condition category
Condition code
Cardiovascular 292248 292248 0 0
Coronary heart disease
Cardiovascular 292249 292249 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Arm 1
a. AlaskOmega® 400200 TG 1000mg (Bioriginal, Nehterlands) (containing 400mg EPA and 200mg DHA per capsule), ensuring the patients receive 1800 mg of n-3 LCPUFA

b. softgel oral capsule

c. 3 capsules once daily for minimum 6 months


All study drugs will be given to participants in a 28-day Webster pack. Participants will have their monthly supply delivered to them (at home or clinic) by a member of the clinical team. The study participant will be asked to return the used and unused containers at each visit. Accountability of IP consumption will be evaluated by a member of the clinical team through subject interview and the counting of unused study drug. Compliance (percent) = (the number consumed) ÷ (the number prescribed) x 100. Lost or discarded IP should not be included in the calculation. This information will be recorded on a standard reporting form and monitored across the program. If compliance is less than 80%, subjects will receive additional instructions about treatment regimens.
Intervention code [1] 289374 0
Treatment: Drugs
Comparator / control treatment
Arm 2
placebo
a. 1000 mg oil blend containing palm oil, gelatin, glycerol, sunflower oil, rapeseed oil, mixed tocopherols and a small amount of fish oil (for taste) to aid blinding

b. softgel oral capsule

c. 3 capsules once daily for minimum 6 months.
Control group
Placebo

Outcomes
Primary outcome [1] 292114 0
The impact of Omega 3 (n-3 PUFA) supplementation on non-HDL-C levels assessed by serum assay
Timepoint [1] 292114 0
6 months after randomisation
Secondary outcome [1] 308223 0
Assessment of the impact of Omega 3 (n-3 PUFA) supplementation on reducing blood levels of triglycerides, total cholesterol, and LDL cholesterol assessed by serum assay
Timepoint [1] 308223 0
6 months after randomisation
Secondary outcome [2] 309174 0
Assessment of the impact of Omega 3 (n-3 PUFA) supplementation on increasing HDL cholesterol levels assessed by serum assay
Timepoint [2] 309174 0
6 months after randomisation
Secondary outcome [3] 309175 0
Assessment of the impact of Omega 3 (n-3 PUFA) supplementation on improving lipid functionality as measured by cholesterol efflux and plasma cholesteryl ester transfer protein [CETP] activity.
Timepoint [3] 309175 0
12 months after randomisation
Secondary outcome [4] 309176 0
6 months after randomisation
Timepoint [4] 309176 0
6 months after randomisation
Secondary outcome [5] 309177 0
6 months after randomisation
Timepoint [5] 309177 0
6 months after randomisation
Secondary outcome [6] 309178 0
6 months after randomisation
Timepoint [6] 309178 0
6 months after randomisation
Secondary outcome [7] 309179 0
Assessment of the impact of Omega 3 (n-3 PUFA) supplementation on reducing the cumulative rate of combined Major Adverse Cardiac Events - including death, non-fatal myocardial infarction or unstable angina, non-fatal stroke, revascularisation (e.g. coronary artery bypass graft, percutaneous coronary intervention) and cardiac related hospital admissions.
Timepoint [7] 309179 0
6 months after randomisation

Eligibility
Key inclusion criteria
* Men or women, self-identified as Indigenous
* Aged over 18 years
* Have confirmed Coronary Artery Disease [CAD] (according to nationally consistent definitions):
* Prior hospitalisation for myocardial infarction/acute coronary syndrome
* Prior revascularisation
* Proven coronary stenosis >50%
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Non-residents of South Australia or Alice Springs, NT.
* Patients with significant neurological/cognitive impairment that prevents consent
* Hypersensitivity or documented allergy to the study drug
* Known bleeding disorder or end-stage renal disease requiring dialysis

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)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis
All analyses will be performed on an intention-to-treat basis. Comparison of baseline and end-point data will involve chi-square analysis (with calculation of OR and 95% CI) for discrete variables, Student’s t test for normally distributed continuous variables and Mann-Whitney tests for non-normally distributed variables. Kaplan-Meier survival curves will be constructed using time-dependent, all-cause survival and event-free survival data. Survival and event-free data will be further analysed (log-rank and Breslow test) for any differences in the number and/or timing of events. Where applicable, study end-points will be calculated as the frequency of events/patient/month of follow-up. The change from baseline markers will be analysed by a mixed-model, repeated measures ANOVA. The model will include effects of treatment, time period, and treatment-by-time interactions and changes from baseline to 12 months compared by a two-sample t-test.

Based on a two-sided alpha of 0.05, a total of 85 patients in each group (170 in total) will provide 90% power to detect a clinically significant 15% additional reduction in non-HDL cholesterol as the primary endpoint for those randomised to n-3 PUFA compared to placebo. 15% decreases in atherogenic lipid parameters are considered clinically relevant by contemporary trials and regulatory authorities for approval of lipid lowering drugs. We will aim to recruit a total of 220 participants (110:110) to allow for 25% loss to follow-up over the 12-month intervention period.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/10/2014
Actual
1/05/2015
Date of last participant enrolment
Anticipated
30/06/2017
Actual
13/04/2017
Date of last data collection
Anticipated
Actual
13/11/2017
Sample size
Target
220
Accrual to date
Final
89
Recruitment in Australia
Recruitment state(s)
NT,SA

Funding & Sponsors
Funding source category [1] 289231 0
Government body
Name [1] 289231 0
National Health and Medical Research Council
Country [1] 289231 0
Australia
Primary sponsor type
Other
Name
South Australian Health and Medical Research Institute
Address
North Terrace
Adelaide, SA 5000
Country
Australia
Secondary sponsor category [1] 287904 0
None
Name [1] 287904 0
Address [1] 287904 0
Country [1] 287904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291000 0
Aboriginal Health Research Ethics Committee
Ethics committee address [1] 291000 0
Ethics committee country [1] 291000 0
Australia
Date submitted for ethics approval [1] 291000 0
Approval date [1] 291000 0
10/04/2014
Ethics approval number [1] 291000 0
04-14-556
Ethics committee name [2] 291001 0
Royal Adelaide Research Ethics Committee
Ethics committee address [2] 291001 0
Ethics committee country [2] 291001 0
Australia
Date submitted for ethics approval [2] 291001 0
11/06/2014
Approval date [2] 291001 0
01/08/2014
Ethics approval number [2] 291001 0
Ethics committee name [3] 297429 0
Central Australian Human Research Ethics Committee
Ethics committee address [3] 297429 0
Ethics committee country [3] 297429 0
Australia
Date submitted for ethics approval [3] 297429 0
28/04/2016
Approval date [3] 297429 0
20/09/2016
Ethics approval number [3] 297429 0
HREC-16-381

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

Contacts
Principal investigator
Name 48406 0
Prof Alex Brown
Address 48406 0
Wardliparingga Aboriginal Research Unit, SAHMRI
PO Box 11060, Adelaide, SA 5001
Country 48406 0
Australia
Phone 48406 0
+61 8 8128 4210
Fax 48406 0
Email 48406 0
[email protected]
Contact person for public queries
Name 48407 0
Alex Brown
Address 48407 0
Wardliparingga Aboriginal Research Unit, SAHMRI
PO Box 11060, Adelaide, SA 5001
Country 48407 0
Australia
Phone 48407 0
+61 8 8128 4210
Fax 48407 0
Email 48407 0
[email protected]
Contact person for scientific queries
Name 48408 0
Alex Brown
Address 48408 0
Wardliparingga Aboriginal Research Unit, SAHMRI
PO Box 11060, Adelaide, SA 5001
Country 48408 0
Australia
Phone 48408 0
+61 8 8128 4210
Fax 48408 0
Email 48408 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.