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The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications
BACKGROUND: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failu...
Autores principales: | , , , , , , , , , , , , |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2015
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482267/ https://www.ncbi.nlm.nih.gov/pubmed/26116581 http://dx.doi.org/10.1186/s12882-015-0089-2 |
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author | Viecelli, Andrea K. Pascoe, Elaine Polkinghorne, Kevan R. Hawley, Carmel Paul-Brent, Peta-Anne Badve, Sunil V. Cass, Alan Heritier, Stephane Kerr, Peter G. Mori, Trevor A. Robertson, Amanda Seong, Hooi L. Irish, Ashley B. |
author_facet | Viecelli, Andrea K. Pascoe, Elaine Polkinghorne, Kevan R. Hawley, Carmel Paul-Brent, Peta-Anne Badve, Sunil V. Cass, Alan Heritier, Stephane Kerr, Peter G. Mori, Trevor A. Robertson, Amanda Seong, Hooi L. Irish, Ashley B. |
author_sort | Viecelli, Andrea K. |
collection | PubMed |
description | BACKGROUND: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design. METHODS/DESIGN: The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome ‘early thrombosis’ at 3 months following AVF creation was broadened to a more clinically relevant outcome of ‘AVF access failure’; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure. DISCUSSION: This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enrol a more representative cohort of haemodialysis patients, who are significantly older with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of the study. TRIAL REGISTRATION: Australia & New Zealand Clinical Trial Register (ACTRN12607000569404) |
format | Online Article Text |
id | pubmed-4482267 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2015 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-44822672015-06-27 The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications Viecelli, Andrea K. Pascoe, Elaine Polkinghorne, Kevan R. Hawley, Carmel Paul-Brent, Peta-Anne Badve, Sunil V. Cass, Alan Heritier, Stephane Kerr, Peter G. Mori, Trevor A. Robertson, Amanda Seong, Hooi L. Irish, Ashley B. BMC Nephrol Study Protocol BACKGROUND: The FAVOURED study is an international multicentre, double-blind, placebo-controlled trial which commenced recruitment in 2008 and examines whether omega-3 polyunsaturated fatty acids (omega-3 PUFAs) either alone or in combination with aspirin will effectively reduce primary access failure of de novo arteriovenous fistulae (AVF) in patients with stage 4 and 5 chronic kidney disease. Publication of new evidence derived from additional studies of clopidogrel and a high screen failure rate due to prevalent aspirin usage prompted an updated trial design. METHODS/DESIGN: The original trial protocol published in 2009 has undergone two major amendments, which were implemented in 2011. Firstly, the primary outcome ‘early thrombosis’ at 3 months following AVF creation was broadened to a more clinically relevant outcome of ‘AVF access failure’; a composite of thrombosis, AVF abandonment and cannulation failure at 12 months. Secondly, participants unable to cease using aspirin were allowed to be enrolled and randomised to omega-3 PUFAs or placebo. The revised primary aim of the FAVOURED study is to test the hypothesis that omega-3 PUFAs will reduce rates of AVF access failure within 12 months following AVF surgery. The secondary aims are to examine the effect of omega-3 PUFAs and aspirin on the individual components of the primary end-point, to examine the safety of study interventions and assess central venous catheter requirement as a result of access failure. DISCUSSION: This multicentre international clinical trial was amended to address the clinically relevant question of whether the usability of de novo AVF at 12 months can be improved by the early use of omega-3 PUFAs and to a lesser extent aspirin. This study protocol amendment was made in response to a large trial demonstrating that clopidogrel is effective in safely preventing primary AVF thrombosis, but ineffective at increasing functional patency. Secondly, including patients taking aspirin will enrol a more representative cohort of haemodialysis patients, who are significantly older with a higher prevalence of cardiovascular disease and diabetes which may increase event rates and the power of the study. TRIAL REGISTRATION: Australia & New Zealand Clinical Trial Register (ACTRN12607000569404) BioMed Central 2015-06-27 /pmc/articles/PMC4482267/ /pubmed/26116581 http://dx.doi.org/10.1186/s12882-015-0089-2 Text en © Viecelli et al. 2015 This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/4.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Study Protocol Viecelli, Andrea K. Pascoe, Elaine Polkinghorne, Kevan R. Hawley, Carmel Paul-Brent, Peta-Anne Badve, Sunil V. Cass, Alan Heritier, Stephane Kerr, Peter G. Mori, Trevor A. Robertson, Amanda Seong, Hooi L. Irish, Ashley B. The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title | The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title_full | The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title_fullStr | The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title_full_unstemmed | The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title_short | The Omega-3 fatty acids (Fish Oils) and Aspirin in Vascular access OUtcomes in REnal Disease (FAVOURED) study: the updated final trial protocol and rationale of post-initiation trial modifications |
title_sort | omega-3 fatty acids (fish oils) and aspirin in vascular access outcomes in renal disease (favoured) study: the updated final trial protocol and rationale of post-initiation trial modifications |
topic | Study Protocol |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4482267/ https://www.ncbi.nlm.nih.gov/pubmed/26116581 http://dx.doi.org/10.1186/s12882-015-0089-2 |
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