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Design of the Dialysis Access Consortium (DAC) clopidogrel prevention of early AV fistula thrombosis trial

Renal Section, Boston University School of Medicine, EBRC 504, 650 Albany Street, Boston, MA 02118 USA ldember{at}bu.edu

James S Kaufman

Boston University School of Medicine, Boston, MA, USA

Gerald J Beck

Cleveland Clinic Foundation, Cleveland, OH, USA

Bradley S Dixon

University of Iowa, Iowa City, IA, USA

Jennifer J Gassman

Tom Greene

Cleveland Clinic Foundation, Cleveland, OH, USA

Jonathan Himmelfarb

Maine Medical Center, Portland, Maine, USA

Lawrence G Hunsicker

University of Iowa, Iowa City, IA, USA

John W Kusek

National Institute of Diabetes and Digestive and Kidney Disease, Bethesda, MD, USA

Jeffrey H Lawson

John P Middleton

Duke University Medical Center, Durham, NC, USA

Milena Radeva

Cleveland Clinic Foundation, Cleveland, OH, USA

Steve J Schwab

Medical College of Georgia, Augusta, GA, USA

James F Whiting

Maine Medical Center, Portland, Maine, USA

Harold I Feldman

University of Pennsylvania School of Medicine, Philadelphia, PA, USA

Background The Dialysis Access Consortium (DAC) was developed to investigate interventions to improve hemodialysis vascular access outcomes. The autogenous arteriovenous fistula created by direct connection of native artery to vein is the recommended vascular access for hemodialysis. However, it fails frequently due to clotting after surgery.

Purpose The DAC Early AV Fistula Thrombosis Trial tests the hypothesis that clopidogrel can prevent early fistula failure and increase the number of fistulas that ultimately become usable for hemodialysis access. This is one of two initial and concurrent trials being performed by the DAC. The companion trial investigates pharmacologic approaches to prevent venous stenosis leading to AV graft failure.

Methods This is a multicenter, randomized, double-blind, placebo-controlled trial that will enroll 1284 patients over four years. Patients undergoing creation of a new native arteriovenous (AV) fistula are randomized to treatment with clopidogrel or placebo for six weeks following fistula creation surgery. The primary outcome is fistula patency at six weeks. The major secondary outcome is fistula suitability for dialysis.

Results This paper examines key aspects of this study that have broad relevance to trial design including: 1) the selection of an intermediate event as the primary outcome, 2) timing of the intervention to balance efficacy and safety concerns, 3) ethical considerations arising from required modifications of concomitant drug therapy, and 4) choosing an efficacy or effectiveness evaluation of the intervention.

Conclusions This is the first, large, multicenter trial evaluating a pharmacologic approach to prevent early AV fistula failure and promote more usable fistulas for hemodialysis. The methodologic challenges identified and addressed during the development of this trial should help to inform the design of future vascular access trials, and are relevant to clinical trials addressing a wide range of questions.

Clinical Trials, Vol. 2, No. 5, 413-422 (2005)
DOI: 10.1191/1740774505cn118oa


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