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
Andrea K Viecelli, Elaine Pascoe, Kevan R Polkinghorne, Carmel Hawley, Peta-Anne Paul-Brent, Sunil V Badve, Alan Cass, Stephane Heritier, Peter G Kerr, Trevor A Mori, Amanda Robertson, Hooi L Seong, Ashley B Irish
BMC Nephrology | BMC | Published : 2015
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. F..View full abstract
Awarded by Australian & New Zealand Clinical Trials Register
The study is funded by a National Health and Medical Research Council (NHMRC) Project Grant and registered with the Australian & New Zealand Clinical Trials Register (ACTRN12607000569404). The trial is supported by unrestricted grants provided by Abbott Products Operations AG and Amgen Australia Pty Ltd. The authors gratefully acknowledge the contributions of all members of the FAVOURED Trial Study Group, dialysis nursing staff, trial co-ordinators, research staff and participants. The authors are grateful to Bayer Healthcare for supplying the aspirin and matched placebo and Abbott Products for supplying the Omacor capsules and matched placebo.