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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.

Viecelli AK, Pascoe E, Polkinghorne KR, Hawley C, Paul-Brent PA, Badve SV, Cass A, Heritier S, Kerr PG, Mori TA, Robertson A, Seong HL, Irish AB, FAVOURED study te - BMC Nephrol (2015)

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. andrea.viecelli@health.qld.gov.au.

ABSTRACT

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 enroll 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).

No MeSH data available.


Related in: MedlinePlus

Screening log data
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Related In: Results  -  Collection

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Fig2: Screening log data

Mentions: Recruitment for the FAVOURED trial started on the 21st of August 2008. As shown in Fig. 2, a total of 4242 patients were screened. Of the 2334 patients that were screened prior to the study protocol amendment in June 2011, 1842 were excluded, mainly due to the use of anticoagulants or anti-platelet agents including use of aspirin or fish oil (39 %, exclusion criteria 2 [26 %] and 4 [13 %]). Of the 492 patients deemed suitable, 184 (37 %) were enrolled. The two main reasons the remaining 308 patients were not enrolled were patient disinterest (37 %) and unknown reasons (28 %). After introduction of the updated study protocol in June 2011 with the inclusion of open-label aspirin use for those taking aspirin and unable to cease, almost half of patients screened (909 out of 1908 participants) were deemed suitable and of these 384 were enrolled in the trial. Only 10 % of the patients screened after the protocol amendments (197 out of 999) were excluded due to use of anti-platelet or thrombolytic agents including aspirin and fish oil.Fig. 2


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 AK, Pascoe E, Polkinghorne KR, Hawley C, Paul-Brent PA, Badve SV, Cass A, Heritier S, Kerr PG, Mori TA, Robertson A, Seong HL, Irish AB, FAVOURED study te - BMC Nephrol (2015)

Screening log data
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4482267&req=5

Fig2: Screening log data
Mentions: Recruitment for the FAVOURED trial started on the 21st of August 2008. As shown in Fig. 2, a total of 4242 patients were screened. Of the 2334 patients that were screened prior to the study protocol amendment in June 2011, 1842 were excluded, mainly due to the use of anticoagulants or anti-platelet agents including use of aspirin or fish oil (39 %, exclusion criteria 2 [26 %] and 4 [13 %]). Of the 492 patients deemed suitable, 184 (37 %) were enrolled. The two main reasons the remaining 308 patients were not enrolled were patient disinterest (37 %) and unknown reasons (28 %). After introduction of the updated study protocol in June 2011 with the inclusion of open-label aspirin use for those taking aspirin and unable to cease, almost half of patients screened (909 out of 1908 participants) were deemed suitable and of these 384 were enrolled in the trial. Only 10 % of the patients screened after the protocol amendments (197 out of 999) were excluded due to use of anti-platelet or thrombolytic agents including aspirin and fish oil.Fig. 2

Bottom Line: 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.

View Article: PubMed Central - PubMed

Affiliation: Department of Nephrology, Princess Alexandra Hospital, Brisbane, QLD, Australia. andrea.viecelli@health.qld.gov.au.

ABSTRACT

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 enroll 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).

No MeSH data available.


Related in: MedlinePlus