The Aboriginal Cardiovascular Omega-3 Randomised Controlled Trial

Phase 4

Completed

• Conditions: atherosclerosis; factors associated with thrombus formation; heart rate variability; Coronary Artery Disease; Cardiovascular - Coronary heart disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12614000732684
• Lead Sponsor: South Australian Health and Medical Research Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-07-10
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 220

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%

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

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The impact of Omega 3 (n-3 PUFA) supplementation on non-HDL-C levels assessed by serum assay[6 months after randomisation]